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huCART19-IL18 in CD19+ Cancers

Primary Purpose

Chronic Lymphocytic Leukemia, Non-hodgkin Lymphoma, Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
huCART19-IL18
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, NHL, CAR-T cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent form
  2. Documentation of CD19 expression on malignant cells

    1. CLL: At time of most recent relapse
    2. NHL: Within 6 months of physician-investigator confirmation of eligibility as long as there has been no intervening CD19 directed therapy since expression confirmed. Results outside of this window may be used, if there is no accessible tumor site and the subject did not receive intervening CD19 directed therapy since CD19 expression was confirmed.
  3. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:

    1. Have no active GVHD and require no immunosuppression
    2. Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility
  4. Adequate organ function defined as:

    a. Creatinine ≤ 1.6 mg/dl b. ALT/AST ≤ 3x upper limit of normal range c. Direct bilirubin ≤ 2.0 mg/dl, unless the subject has Gilbert's syndrome (≤3.0 mg/dl) d. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air e. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA

  5. Evidence of active disease. This could include circulating disease in the blood, disease in the bone marrow by standard morphology, or in NHL patients, measurable disease per Lugano criteria.
  6. Male or female age ≥ 18 years.
  7. ECOG Performance Status that is either 0 or 1.
  8. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol
  9. Disease-specific criteria:

    a. Chronic Lymphocytic Leukemia (CLL): i. Patients with relapsed/refractory disease after at least 2 prior lines of appropriate therapy; and ii. Patients must have previously received, or be intolerant to an approved BTK inhibitor and venetoclax, unless a BTK inhibitor or venetoclax is contraindicated.

    b. Non-Hodgkin Lymphoma (NHL): i. Patients with any of the following diagnoses: Diffuse Large B-cell Lymphoma not otherwise specified (DLBCL NOS), germinal center or activated B-cell types; Primary Cutaneous DLBCL; Primary Mediastinal (thymic) Large B-cell Lymphoma; ALK+ Anaplastic Large B-cell Lymphoma; High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangements (i.e. "Double or Triple Hit"); High-grade B-cell Lymphoma, NOS; T-cell Rich B-cell Lymphoma; Transformed Follicular Lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma.

1. Patients must have either relapsed after, or be ineligible for, prior CAR T cell therapy, and meet one of the following criteria:

  1. Relapsed/refractory disease after at least 2 prior lines of appropriate therapy and are ineligible for autologous stem cell transplant or commercial CAR T cell therapy.
  2. Relapsed/refractory disease after autologous SCT.
  3. Relapsed/refractory disease after allogeneic SCT. ii. Follicular lymphoma 1. Patients who have received at least 2 prior lines of appropriate therapy (not including single agent monoclonal antibody therapy) and progressed within 2 years after second or higher line of therapy.

iii. Mantle cell lymphoma

  1. Patients must have either failed or be ineligible for standard of care Tecartus™ (brexucabtagene autoleucel) or other investigational CAR T cell product; and
  2. Patients must also meet one of the following criteria:

    1. Relapsed/refractory disease after at least 2 prior lines of appropriate therapy, including a BTK inhibitor. Single-agent monoclonal antibody therapy does not count towards prior lines of therapy.
    2. Relapsed/refractory disease after prior autologous SCT.
    3. Relapsed/refractory disease after prior allogeneic SCT. iv. Large cell transformation of CLL (Richter's Transformation)

1. Patients must be primary refractory or received at least 1 prior line of treatment.

Exclusion Criteria:

  1. Active hepatitis B, active hepatitis C, or other active, uncontrolled infection.
  2. Class III/IV cardiovascular disability according to the New York Heart Association Classification
  3. Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
  4. Active acute or chronic GVHD requiring systemic therapy.
  5. Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications
  6. Receipt of immune checkpoint inhibitors within 4 months prior to physician-investigator confirmation of eligibility.
  7. Receipt of prior huCART19 therapy.
  8. Active CNS disease. Note: Patients with a history of CNS involvement that was successfully treated are eligible. A CNS evaluation is only required for eligibility if a subject is experiencing signs/symptoms of CNS involvement.
  9. Pregnant or nursing (lactating) women.
  10. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to their cancer or previous cancer treatment.
  11. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

NHL Dose Level 1a (DL1a)

NHL Dose Level -1 (DL-1)

NHL Dose Level 1b (DL1b)

NHL Dose Level 2 (DL2)

NHL Dose Level 3 (DL3)

NHL Dose Level 4 (DL4)

NHL Dose Level 5 (DL5)

CLL Dose Level 1b (DL1b)

CLL Dose Level 2 (DL2)

CLL Dose Level 3 (DL3)

CLL Dose Level 4 (DL4)

CLL Dose Level 5 (DL5)

ALL Dose Level 1b (DL1b)

ALL Dose Level 2 (DL2)

ALL Dose Level 3 (DL3)

ALL Dose Level 4 (DL4)

ALL Dose Level 5 (DL5)

Arm Description

3x10^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push

7x10^5 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 1a.

3x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

7x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

7x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 2.

7x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

7x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 2.

7x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

7x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

3x10^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.

Secondary Outcome Measures

Occurrence of dose-limiting toxicities (DLTs).
Determination of Maximum Tolerated Dose (MTD)
Percentage of manufacturing products that meet release criteria.
Overall Response Rate (ORR).
Cohort A (NHL) and Cohort B (CLL)
Overall Remission Rate (ORR).
Cohort C (ALL)
Best Overall Response (BOR)
Cohort A (NHL) and Cohort B (CLL)
Best Overall Response (BOR)
Duration of Response (DOR)
Overall Survival (OS)
Progression free survival (PFS)
Event Free Survival (EFS)
Cohort C (ALL)
Characterize low level disease and B cell assessment in response to huCART19-IL18 cells
Polychromatic flow cytometry-based assessment of leukemia and B cells, extent and duration of leukemic response
Characterize low level disease and B cell assessment in response to huCART19-IL18 cells
Presence or absence of malignant B cells by Next-Generation Immunoglobulin heavy chain Sequencing (NGIS)

Full Information

First Posted
December 11, 2020
Last Updated
June 20, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04684563
Brief Title
huCART19-IL18 in CD19+ Cancers
Official Title
Phase I Trial of huCART19-IL18 Cells in Patients With Relapsed or Refractory CD19+ Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
May 2036 (Anticipated)
Study Completion Date
May 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to find the maximum dose of huCART19-IL18 cells that is safe for use in humans with CD19+ cancers.
Detailed Description
This is a Phase I dose finding study to determine the maximum tolerated dose (MTD) and assess the safety, tolerability, manufacturing feasibility, pharmacokinetics, and preliminary efficacy of huCART19-IL18 cells in patients with CD19+ cancers. Up to 7 total dose levels will be evaluated using the Bayesian Optimal Interval (BOIN) design with accelerated titration in order to determine the maximum tolerated dose (MTD) of huCART19-IL18 cells within each of the following disease-specific cohorts: Cohort A: Non-Hodgkin Lymphoma (NHL) Cohort B: Chronic Lymphocytic Leukemia (CLL) Cohort C: Acute Lymphoblastic Leukemia (ALL)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Non-hodgkin Lymphoma, Acute Lymphoblastic Leukemia
Keywords
CLL, NHL, CAR-T cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This trial will evaluate up to 7 dose levels using the Bayesian Optimal Interval (BOIN) design with accelerated titration to determine the maximum tolerated dose (MTD) of huCART19-IL18 cells. Subjects will be assigned to a dose level prior to study treatment based on available safety experience at the current and prior dose levels.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NHL Dose Level 1a (DL1a)
Arm Type
Experimental
Arm Description
3x10^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push
Arm Title
NHL Dose Level -1 (DL-1)
Arm Type
Experimental
Arm Description
7x10^5 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 1a.
Arm Title
NHL Dose Level 1b (DL1b)
Arm Type
Experimental
Arm Description
3x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
NHL Dose Level 2 (DL2)
Arm Type
Experimental
Arm Description
7x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
NHL Dose Level 3 (DL3)
Arm Type
Experimental
Arm Description
3x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
NHL Dose Level 4 (DL4)
Arm Type
Experimental
Arm Description
7x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
NHL Dose Level 5 (DL5)
Arm Type
Experimental
Arm Description
3x10^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
CLL Dose Level 1b (DL1b)
Arm Type
Experimental
Arm Description
3x10^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 2.
Arm Title
CLL Dose Level 2 (DL2)
Arm Type
Experimental
Arm Description
7x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
CLL Dose Level 3 (DL3)
Arm Type
Experimental
Arm Description
3x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
CLL Dose Level 4 (DL4)
Arm Type
Experimental
Arm Description
7x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
CLL Dose Level 5 (DL5)
Arm Type
Experimental
Arm Description
3x10^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
ALL Dose Level 1b (DL1b)
Arm Type
Experimental
Arm Description
3x10^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 2.
Arm Title
ALL Dose Level 2 (DL2)
Arm Type
Experimental
Arm Description
7x10^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
ALL Dose Level 3 (DL3)
Arm Type
Experimental
Arm Description
3x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
ALL Dose Level 4 (DL4)
Arm Type
Experimental
Arm Description
7x10^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Arm Title
ALL Dose Level 5 (DL5)
Arm Type
Experimental
Arm Description
3x10^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Intervention Type
Biological
Intervention Name(s)
huCART19-IL18
Intervention Description
autologous Chimeric Antigen Receptor (CAR) T cells directed against the human CD19 antigen that also express human Interleukin 18 (IL-18)
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Occurrence of dose-limiting toxicities (DLTs).
Time Frame
3 months
Title
Determination of Maximum Tolerated Dose (MTD)
Time Frame
3 months
Title
Percentage of manufacturing products that meet release criteria.
Time Frame
3 months
Title
Overall Response Rate (ORR).
Description
Cohort A (NHL) and Cohort B (CLL)
Time Frame
3 months
Title
Overall Remission Rate (ORR).
Description
Cohort C (ALL)
Time Frame
1 months
Title
Best Overall Response (BOR)
Description
Cohort A (NHL) and Cohort B (CLL)
Time Frame
3 months
Title
Best Overall Response (BOR)
Time Frame
6 months
Title
Duration of Response (DOR)
Time Frame
12 months
Title
Overall Survival (OS)
Time Frame
12 months
Title
Progression free survival (PFS)
Time Frame
12 months
Title
Event Free Survival (EFS)
Description
Cohort C (ALL)
Time Frame
12 months
Title
Characterize low level disease and B cell assessment in response to huCART19-IL18 cells
Description
Polychromatic flow cytometry-based assessment of leukemia and B cells, extent and duration of leukemic response
Time Frame
12 months
Title
Characterize low level disease and B cell assessment in response to huCART19-IL18 cells
Description
Presence or absence of malignant B cells by Next-Generation Immunoglobulin heavy chain Sequencing (NGIS)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent form Documentation of CD19 expression on malignant cells a. Cohort A (NHL): Within 6 months of physician-investigator confirmation of eligibility as long as there has been no intervening CD19 directed therapy since expression confirmed. Results outside of this window may be used, if there is no accessible tumor site and the subject did not receive intervening CD19 directed therapy since CD19 expression was confirmed. b. Cohorts B (CLL) and C (ALL): At time of most recent relapse Patients with relapsed disease after prior allogeneic SCT must meet the following criteria: Have no active GVHD and require no immunosuppression Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility Adequate organ function defined as: Creatinine ≤ 1.6 mg/dl ALT/AST ≤ 3x upper limit of normal range Direct bilirubin ≤ 2.0 mg/dl, unless the subject has Gilbert's syndrome (≤3.0 mg/dl) Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA Evidence of active disease within 12 weeks of physician-investigator confirmation of eligibility. . Male or female age ≥ 18 years. ECOG Performance Status that is either 0 or 1. Subjects of reproductive potential must agree to use acceptable birth control methods. Disease-specific criteria: a. Cohort A (NHL): i. Patients with any of the following diagnoses: Diffuse Large B-cell Lymphoma not otherwise specified (DLBCL NOS), germinal center or activated B-cell types; Primary Cutaneous DLBCL; Primary Mediastinal (thymic) Large B-cell Lymphoma; ALK+ Anaplastic Large B-cell Lymphoma; High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangements (i.e. "Double or Triple Hit"); High-grade B-cell Lymphoma, NOS; T-cell Rich B-cell Lymphoma; Transformed Follicular Lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma. 1. Patients must have either relapsed after, or be ineligible for, prior CAR T cell therapy, and meet one of the following criteria: Relapsed/refractory disease after at least 2 prior lines of appropriate therapy and are ineligible for autologous stem cell transplant; OR Relapsed/refractory disease after autologous SCT; OR Relapsed/refractory disease after allogeneic SCT. ii. Follicular lymphoma Patients must have either relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND Received at least 2 prior lines of appropriate therapy (not including single agent monoclonal antibody therapy) and progressed within 2 years after second or higher line of therapy. iii. Mantle cell lymphoma Patients must have either failed standard of care CAR T cell therapy (e.g. Tecartus™, etc) or other investigational CAR T cell product, OR be ineligible for standard of care Tecartus™; and Patients must also meet one of the following criteria: Relapsed/refractory disease after at least 2 prior lines of appropriate therapy, including a BTK inhibitor. Single-agent monoclonal antibody therapy does not count towards prior lines of therapy; OR Relapsed/refractory disease after prior autologous SCT; OR Relapsed/refractory disease after prior allogeneic SCT. iv. Large cell transformation of CLL (Richter's Transformation) 1. Patients must be primary refractory or received at least 1 prior line of treatment. b. Cohort B (CLL): i. Patients with relapsed/refractory disease after at least 2 prior lines of appropriate therapy; AND ii. Patients must have previously received, or be intolerant to an approved BTK inhibitor and venetoclax, unless a BTK inhibitor or venetoclax is contraindicated. c. Cohort C (ALL): i. Patients with b-cell acute lymphoblastic leukemia. Note: Chronic myeloid leukemia (CML) lymphoid blast crisis is considered a sub-type of relapsed B-ALL, thus will be encompassed in our definition of B-ALL throughout; AND ii. Patients with 2nd or greater relapse or refractory disease as defined by one of the following criteria: Recurrent disease in the blood or bone marrow identified morphologically, by IHC or flow; OR Isolated CNS disease. Note: Patients with prior/current history of CNS3 disease will only be eligible for treatment if the CNS disease is responsive to therapy; OR Recurrent extramedullary disease at other (non-CNS) sites if disease response can be assessed radiographically. Note: Patients with recurrent extramedullary disease do not need to have detectable blood or bone marrow involvement; OR Any relapse after allogeneic SCT; OR Patients with refractory disease as defined by one of the following: Failure to achieve remission (<5% bone marrow blasts or ongoing extramedullary or CNS disease) after 2 cycles of induction chemotherapy; OR Patients that achieve remission but remain MRD+ after ≥2 cycles of induction chemotherapy. Exclusion Criteria: Active hepatitis B, active hepatitis C, or other active, uncontrolled infection. Class III/IV cardiovascular disability according to the New York Heart Association Classification. Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility. Active acute or chronic GVHD requiring systemic therapy. Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications. RETIRED WITH PROTOCOL AMENDMENT V7 Receipt of prior huCART19 therapy. CNS disease as defined by disease-cohort as follows: Cohorts A + B: Active CNS disease. Note: Patients with a history of CNS involvement that was successfully treated are eligible. A CNS evaluation is only required for eligibility if a subject is experiencing signs/symptoms of CNS involvement. Cohort C: CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity. Pregnant or nursing (lactating) women. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to their cancer or previous cancer treatment. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abramson Cancer Center Clinical Trials Service
Phone
855-216-0098
Email
PennCancerTrials@careboxhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Svoboda, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abramson Cancer Center Clinical Trials Service
Phone
855-216-0098
Email
PennCancerTrials@careboxhealth.com

12. IPD Sharing Statement

Plan to Share IPD
No

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huCART19-IL18 in CD19+ Cancers

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