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CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Primary Purpose

B-NHL, B-Non Hodgkin Lymphoma, Acute Lymphocytic Leukemia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fludarabine
cyclophosphamide
CD19/CD22-CAR-transduced T cells
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-NHL focused on measuring Philadelphia chromosome + ALL, Lymphoma, CD-22 Expressing Tumor, CD-19 expressing tumor, Adoptive Immunotherapy, B-All, B-precursor ALL, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, B-Non Hodgkin Lymphoma

Eligibility Criteria

3 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers
  • INCLUSION CRITERIA:

Diagnosis

  • Participant must have:

    • Pathology confirmed B cell ALL (inclusive of CML with ALL transformation) or high- grade lymphoma (e.g., Burkitt s lymphoma, B-lymphoblastic lymphoma, diffuse large B- cell lymphoma)

      ---Patients with low-grade lymphoma (e.g., follicular lymphoma or mantle cell lymphoma) will be excluded unless there is transformation to high-grade disease

    • Participants must have a disease that is relapsed or refractory after at least one standard chemotherapy regimen and at least one salvage treatment and must either be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT.
    • Participants who have undergone autologous SCT will be eligible, and participants that have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they have no evidence of graft-versus- host disease (GVHD) and have been without immunosuppressive agents for at least 30 days.
    • Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor.
    • Participants must have measurable or evaluable disease at the time of enrollment, defined by any evidence of minimal residual disease or PET-avid disease (lymphoma).
  • CD22/CD19 expression

    • CD9 must be detected on >15% of the malignant cells by immunohistochemistry or > 80% by flow cytometry. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples, and the most easily available tissue sample in each participant will be used.
    • CD22 must be detected and expression levels will be documented when available, but a specific level of expression is not an eligibility requirement; it may be documented as positive.
  • Age >= 3 years of age and <= 35 years of age at time of enrollment.
  • Clinical Performance status: Participants >=16 years of age: Karnofsky >= 50%; Participants < 16 years of age: Lansky scale >= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.
  • Participants must have adequate organ and marrow function as defined below:

    • leukocytes >= 750/mcL*
    • platelets >= 50,000/mcL*
    • total bilirubin <= 2 X ULN (except in the case of participants with documented Gilbert s disease > 3x ULN)
    • AST(SGOT)/ALT(SGPT) <= 10 X institutional upper limit of normal
    • creatinine <= the maximum for age listed in the table below

OR

  • measured creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above the max listed below per age.

    • Age (Years) <= 5 Maximum Serum Creatinine (mg/dL) <= 0.8
    • Age (Years) 6 to <= 10 Maximum Serum Creatinine (mg/dL) <= 1.0
    • Age (Years) >10 Maximum Serum Creatinine (mg/dL) <=1.2

      • a participant will not be excluded because of pancytopenia >= Grade 3 if it is due to underlying bone marrow involvement by leukemia

        • Central nervous system (CNS) Status

          1. Participants with leukemia with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:
  • CNS 1, defined as absence of blasts in CSF on cytospin preparation, regardless of the number of WBCs;
  • CNS 2, defined as presence of < 5/uL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm:

    • CNS 2a: < 10/uL RBCs; < 5/uL WBCs and cytospin positive for blasts;
    • CNS 2b: >=10/uL RBCs; < 5/uL WBCs and cytospin positive for blasts;
    • CNS 2c: >=10/uL RBCs; >=5/uL WBCs and cytospin positive for blasts but negative by Steinherz/Bleyer algorithm.

      • Participants of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving lymphodepletion (LD)
      • Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding while on study therapy and until 1 month after the administration of CAR.
      • Cardiac function: Left ventricular ejection fraction >= 45% or fractional shortening >=28%
      • Pulmonary Function
  • Baseline oxygen saturation >92% on room air at rest
  • Participants with respiratory symptoms must have a DLCO/adjusted > 45%. For children who are unable to cooperate for PFTs they must not have dyspnea at rest or known requirement for supplemental oxygen.

    • Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
    • Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.

EXCLUSION CRITERIA:

Participants meeting any of the following criteria are not eligible for participation in the study:

  • Recurrent or refractory ALL limited to isolated testicular or isolated CNS disease.
  • Participants with radiologically detected active CNS lymphoma or isolated CNS disease
  • Hyperleukocytosis (>= 50,000 blasts/microliter)
  • Participant pregnancy (confirmed with beta-HCG serum or urine pregnancy test performed at screening).
  • Participants will be excluded related to the following prior therapy criteria:

Systemic chemotherapy, anti-neoplastic investigational agents, or antibody based therapies <= 2 weeks (6 weeks for clofarabine or nitrosoureas) prior to apheresis with the following exception:

-No time restriction with prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects.

Radiation therapy <= 3 weeks prior to apheresis with the following exception:

-No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable/evaluable disease outside the radiation window.

History of allogeneic stem cell transplantation prior to apheresis that meet the any of the following criteria:

  • Less than 100 days post-transplant
  • Evidence of active graft-versus-host disease (GVHD)
  • Taking immunosuppressive agents within 30 days prior to apheresis.

Less than 6 weeks post donor lymphocyte infusion (DLI)

History of prior CAR therapy or other adoptive cell therapies prior to apheresis that meet either of the two the following criteria:

  • Less than 30 days post-infusion
  • Circulating CAR T cells (or genetically modified cells) >5% by flow cytometry in peripheral blood
  • Current/active HIV infection, as measured by seropositivity for HIV antibody.
  • Current/active HBV/HCV Infection as measured by seropositivity for hepatitis C or positive for Hepatitis B surface antigen (HbsAG).
  • Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission;
  • History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.
  • Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant;

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1/Phase I Dose Escalation-with standard LD

2/Phase I Dose Escalation- with intensified LD

3/Phase II Dose Expansion- with standard LD

4/Phase II Dose Expansion- with intensified LD

Arm Description

CD19/CD22-CAR-transduced T cells at escalating dose + standard LD

CD19/CD22-CAR-transduced T cells + standard LD

CD19/CD22-CAR-transduced T cells + standard LD

CD19/CD22-CAR-transduced T cells + intensified LD

Outcomes

Primary Outcome Measures

Safety
Assess the safety of administering escalating doses of autologous CD19/CD22-CAR engineered T cells in children and young adults who are CAR-naive/have received interim HSCT or who are CAR-pre-treated with CD19+CD22+ B cell ALL or lymphoma following a cyclophosphamide/fludarabine LD.
Efficacy
Determine the efficacy of CD19/CD22 therapy in participants who are CAR-naive/interim HSCT or who are CAR pre-treated.

Secondary Outcome Measures

Overall response rate
Phase I: Evaluate the ability of CD19/CD22-CAR T cells to mediate clinical activity in children and young adults with CD19+CD22+ B cell ALL or lymphoma.
Progression free survival (PFS) and Overall survival (OS)
Evaluate PFS and OS in participants, separately by phase II cohort
Persistence and expansion
Evaluate persistence and expansion of C19/CD22-CAR T cells in children and young adults with CD19+CD22+ B-ALL or lymphoma
Adverse Events
Phase II: Assess the safety of CD19/CD22 therapy in participants who are CAR-naive/interim HSCT or who are CAR pre-treated.
Feasibility
Determine the feasibility of producing CD19/CD22-CAR T cells meeting the established release criteria.

Full Information

First Posted
July 1, 2022
Last Updated
October 21, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05442515
Brief Title
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
Official Title
Phase 1/2 Dose Escalation Study of CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 19, 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
July 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 35 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....
Detailed Description
Background: Despite improvements in therapy, acute lymphoblastic leukemia (ALL) contributes to significant morbidity and mortality for children and young adults with cancer. CD19-CAR and CD22-CAR therapy have proven highly effective in inducing remission in patients with relapsed/refractory disease. Immune escape has been observed by several groups following CD19-CAR and CD22- CAR therapy for B-ALL. Investigation of this phenomenon reveals a complex biology responsible for loss or downregulation of CD19 and/or CD22 expression observed in these cases. The challenges encountered with currently available CD19- and CD22-directed CAR T cells in B-ALL demonstrates the need for combinatorial treatment strategies simultaneously targeting two antigens, such as CD19 and CD22, to enhance the long-term effectiveness of CARs. We have previously treated patients with B-ALL on a phase 1/2 clinical trial using a bivalent CD19/22 CAR T-cell as a first combinatorial treatment strategy. This CAR T-cell construct is well-tolerated and has yielded responses however there has been limited CAR T cell expansion and persistence. Additionally, the previously tested CD19/CD22 bivalent CAR T-cell construct is limited in its ability to target CD22. This new CD19/22 targeted construct being tested in this clinical trial has improved dual targeting capability based on preclinical data/evaluation. Objectives: Phase I: Assess the safety of administering escalating doses of autologous CD19/CD22- CAR engineered T cells in children and young adults with B cell ALL (stratified by disease burden) or lymphoma following a cyclophosphamide/fludarabine conditioning regimen. Phase II: Determine the efficacy of CD19/CD22 therapy in participants stratified by disease burden. Eligibility: -Participants between >= 3 years and <= 35 years of age, with CD19+/CD22+ B cell ALL or lymphoma who have relapsed or have refractory disease after at least one standard chemotherapy regimen and one salvage regimen, with no alternative curative options. Design: Phase I, 3 + 3 dose escalation design across 3 cohorts (B-ALL: A/ B-lymphoblastic lymphoma: A: low-disease burden (<25 % marrow blasts without extramedullary disease) vs. B: high-disease burden (>= 25 % marrow blasts or with EMD): C: B-cell non-Hodgkin lymphoma using the following dose levels: -2: 1 x 10^5 transduced T cells/kg (+/- 20%); -1: 3 x 0^55 transduced T cells/kg (+/- 20%); 1: 1 x 10^6 transduced T cells/kg (+/- 20%); and 2: 3x 10^6 transduced T cells/kg (+/- 20%). Cohorts will enroll concurrently. Participants will be treated based on disease burden and will receive 1 of 2 lymphodepleting preparative regimens: Lymphodepleting preparative regimen number 1: Fludarabine (30 mg/m^2/d x 3 on Days -4, -3, -2) and cyclophosphamide (900 mg/m^2/d x 1 on Day -2) followed by infusion of CD19/CD22-CAR T-cells on D0. Lymphodepleting preparative regimen #2: Fludarabine (30 mg/m2/d x 4 on Days -5, -4, -3, -2) and cyclophosphamide (600 mg/m2/d x 2 on Days -3, -2) followed by infusion of CD19/CD22-CAR T-cells on D0. Determination for use of LD regimen #1 versus #2 will be based on pre-treatment absolute lymphocyte count, pre-existing cytopenias, receipt of prior CAR T-cell therapy, high disease burden and assessment of infection risk. Participants will be evaluated sequentially for toxicity, antitumor effects, CAR expansion and persistence, and other biologic correlatives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-NHL, B-Non Hodgkin Lymphoma, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, B-precursor ALL, B-All, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, B Cell, B-Cell Lymphoma, B-Cell Leukemia, Acute Lymphoid Leukemia
Keywords
Philadelphia chromosome + ALL, Lymphoma, CD-22 Expressing Tumor, CD-19 expressing tumor, Adoptive Immunotherapy, B-All, B-precursor ALL, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, B-Non Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1/Phase I Dose Escalation-with standard LD
Arm Type
Experimental
Arm Description
CD19/CD22-CAR-transduced T cells at escalating dose + standard LD
Arm Title
2/Phase I Dose Escalation- with intensified LD
Arm Type
Experimental
Arm Description
CD19/CD22-CAR-transduced T cells + standard LD
Arm Title
3/Phase II Dose Expansion- with standard LD
Arm Type
Experimental
Arm Description
CD19/CD22-CAR-transduced T cells + standard LD
Arm Title
4/Phase II Dose Expansion- with intensified LD
Arm Type
Experimental
Arm Description
CD19/CD22-CAR-transduced T cells + intensified LD
Intervention Type
Drug
Intervention Name(s)
fludarabine
Intervention Description
Fludarabine is administered as an IV infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on BSA (25 mg/m2/dose)
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the patient s body weight, at 900 mg/m2/dose after fludarabine infusion.
Intervention Type
Biological
Intervention Name(s)
CD19/CD22-CAR-transduced T cells
Intervention Description
CD19/CD22-CAR-transduced T cells on D0 after lymphodepleting preparative regimen
Primary Outcome Measure Information:
Title
Safety
Description
Assess the safety of administering escalating doses of autologous CD19/CD22-CAR engineered T cells in children and young adults who are CAR-naive/have received interim HSCT or who are CAR-pre-treated with CD19+CD22+ B cell ALL or lymphoma following a cyclophosphamide/fludarabine LD.
Time Frame
30 days post CAR T infusion
Title
Efficacy
Description
Determine the efficacy of CD19/CD22 therapy in participants who are CAR-naive/interim HSCT or who are CAR pre-treated.
Time Frame
Monthly until 3 months post CAR T infusion and then at 6 months and every 6 months after that, for 2 years post-infusion for each participant, up to 2 years after the entry date of the last participant.
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Phase I: Evaluate the ability of CD19/CD22-CAR T cells to mediate clinical activity in children and young adults with CD19+CD22+ B cell ALL or lymphoma.
Time Frame
Monthly until 3 months post infusion and then at 6 months and every 6 months after that, for 2 years post-infusion for each participant, for up to two years from the entry date of the last participant
Title
Progression free survival (PFS) and Overall survival (OS)
Description
Evaluate PFS and OS in participants, separately by phase II cohort
Time Frame
Up to two years after the last participant has entered.
Title
Persistence and expansion
Description
Evaluate persistence and expansion of C19/CD22-CAR T cells in children and young adults with CD19+CD22+ B-ALL or lymphoma
Time Frame
Up to two years after the last participant has entered.
Title
Adverse Events
Description
Phase II: Assess the safety of CD19/CD22 therapy in participants who are CAR-naive/interim HSCT or who are CAR pre-treated.
Time Frame
30 days post CAR T infusion
Title
Feasibility
Description
Determine the feasibility of producing CD19/CD22-CAR T cells meeting the established release criteria.
Time Frame
Up to two years after the last participant has entered.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- INCLUSION CRITERIA: -Diagnosis Participant must: Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt s lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and Have no evidence of graft-versus- host disease (GVHD) and have been without immunosuppressive agents for at least 30 days prior to apheresis, if undergone prior allogeneic SCT; and Be unable to access (in a timely manner), ineligible for, or have relapsed/failed after or not responded to a commercially available CD19 CAR T-cell construct; and Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment. CD22/CD19 expression CD19 must be detected on >15% of the malignant cells by immunohistochemistry or > 80% by flow cytometry. CD22 positivity must be confirmed. Age >= 3 years of age and <=35 years of age at time of enrollment. Clinical Performance status: Participants >= 16 years of age: Karnofsky >= 50%; Participants < 16 years of age: Lansky scale >= 50%. Participants must have adequate organ and marrow function as defined below: leukocytes >=750/mcL platelets >=50,000/mcL total bilirubin <=2 X ULN (except in the case of participants with documented Gilbert s disease > 3x ULN) AST(SGOT)/ALT(SGPT) <=10 X institutional upper limit of normal creatinine <= the maximum for age listed in the table below OR ---measured creatinine clearance >=60 mL/min/1.73 m^2 for participants with creatinine levels above the max listed below per age. Age (Years) <= 5 <TAB>Maximun Serum Creatinine (mg/dL) <= 0.8 Age (Years) 6 to <= 10 <TAB>Maximun Serum Creatinine (mg/dL) <= 1.0 Age (Years) >10 <TAB> Maximun Serum Creatinine (mg/dL) <=1.2 a participant will not be excluded because of pancytopenia >= Grade 3 if it is due to underlying bone marrow involvement by leukemia Central nervous system (CNS) Status a. Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until four months following lymphodepletion (LD) Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding while on study therapy and until 1 month after the administration of CAR. Cardiac function: Left ventricular ejection fraction >= 45% or fractional shortening >=28% Pulmonary Function Baseline oxygen saturation >92% on room air at rest Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials. EXCLUSION CRITERIA: Participants meeting any of the following criteria are not eligible for participation in the study: Participants with CNS3 disease, neurologic signs of CNS disease, radiologically detected active CNS lymphoma Hyperleukocytosis (>= 50,000 blasts/microL) Positive serum or urine <=-HCG pregnancy test performed at screening. Participants will be excluded based on prior therapy if they fail to meet following washout criteria: Therapy <TAB> Washout <TAB> Exceptions Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies <TAB> >=2 weeks <TAB> 6 weeks for clofarabine or nitrosoureas No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects Radiation <TAB>>= 3 weeks <TAB>No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable/evaluable disease outside the radiation window Allogeneic Stem Cell Transplant <TAB> >= 100 days since SCT >= 30 days since completion of immunosuppression >= 6 weeks since donor lymphocyte infusion (DLI) <TAB> Cannot have evidence of active graft-versus-host disease (GVHD) CAR T-Cell Therapy or other Adoptive Cell Therapy <TAB> > 30 days post infusion <TAB> For patients previously treated with CAR T-cells without interim HSCT (cohorts B1 and D1) cannot have circulating CAR T cells (or genetically modified cells) >5% by flow cytometry in peripheral blood Washout: Time between therapy and apheresis Positive HIV antibodies consistent with active HIV. Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current/active HCV/HBV. Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission. History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells. Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NCI Pediatric Leukemia, Lymphoma Transpl
Phone
(240) 760-6970
Email
ncilltct@mail.nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Nirali N Shah, M.D.
Phone
(240) 760-6970
Email
shahnn@mail.nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirali N Shah, M.D.
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone
888-624-1937

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
.All IPD recorded in the medical record will be shared with intramural investigators upon request.
IPD Sharing Time Frame
Clinical data available during the study and indefinitely.
IPD Sharing Access Criteria
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000324-C.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

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