Back to resultsAnti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
Primary Purpose
Acute Lymphoblastic Leukemia ,Lymphomas
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anti-CD19 CAR-T
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia ,Lymphomas focused on measuring acute lymphoblastic leukemia ;Lymphomas
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ，and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment < 2 years, The specific requirements are as follows:
- Male or female aged 18-70 years old ;
- Estimated Survival time > 12 weeks;
- Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging;
- Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas;
- Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level;
- Bilirubin<2.0mg/dl;
- Karnofsky Performance Status>50% at the time of screening;
- Adequate pulmonary, renal, hepatic, and cardiac function;
- Fail in autologous or allogenic haemopoietic stem cell transplantation;
- Not suitable for stem cell transplantation conditions or abandoned due to conditions;
- Free of leukocytes removal contraindications;
- Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent.
Exclusion Criteria:
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
- Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
- The patient is an active hepatitis B or hepatitis C infection;
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
- Abnormal vital signs;
- Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;
- Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2;
- General infection or local severe infection, or other infection that is not controlled;
- Dysfunction in lung, heart, kidney and brain;
- Severe autoimmune diseases;
- Other symptoms that are not applicable for CAR-T.
Sites / Locations
- The First Affiliated Hospital of Nangchang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-CD19 CAR-T
Arm Description
Anti-CD19 CAR-T
Outcomes
Primary Outcome Measures
Overall responce rate(ORR)
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Overall survival (OS)
Assessment of OS(Overall survival) at 6 months of treatment
Progression-free survival (PFS)
Assessment of PFS(Progression-free survival ) at 6 months of treatment
minimal residual disease（MRD）
Assessment of MRD negative overall response rate at 3 months of treatment
Secondary Outcome Measures
Safety (incidence of adverse events defined as dose-limited toxicity)
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Expression of CD19 CART cells
Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.
Detection of CD19 CART cells
Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Full Information
NCT ID
NCT04196205
First Posted
December 9, 2019
Last Updated
December 11, 2019
Sponsor
The First Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT04196205
Brief Title
Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
Official Title
Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
Detailed Description
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia ,Lymphomas
Keywords
acute lymphoblastic leukemia ;Lymphomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-CD19 CAR-T
Arm Type
Experimental
Arm Description
Anti-CD19 CAR-T
Intervention Type
Biological
Intervention Name(s)
Anti-CD19 CAR-T
Intervention Description
1 - 2×10^6 Anti-CD19 CAR-T cells/kg body weigh
Primary Outcome Measure Information:
Title
Overall responce rate(ORR)
Description
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Time Frame
2 years
Title
Overall survival (OS)
Description
Assessment of OS(Overall survival) at 6 months of treatment
Time Frame
2 years
Title
Progression-free survival (PFS)
Description
Assessment of PFS(Progression-free survival ) at 6 months of treatment
Time Frame
2 years
Title
minimal residual disease（MRD）
Description
Assessment of MRD negative overall response rate at 3 months of treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety (incidence of adverse events defined as dose-limited toxicity)
Description
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Time Frame
Study treatment until Week 24
Title
Expression of CD19 CART cells
Description
Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.
Time Frame
2 years
Title
Detection of CD19 CART cells
Description
Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ，and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment < 2 years, The specific requirements are as follows:
Male or female aged 18-70 years old ;
Estimated Survival time > 12 weeks;
Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging;
Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas;
Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level;
Bilirubin<2.0mg/dl;
Karnofsky Performance Status>50% at the time of screening;
Adequate pulmonary, renal, hepatic, and cardiac function;
Fail in autologous or allogenic haemopoietic stem cell transplantation;
Not suitable for stem cell transplantation conditions or abandoned due to conditions;
Free of leukocytes removal contraindications;
Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent.
Exclusion Criteria:
The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
The patient is an active hepatitis B or hepatitis C infection;
Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
Abnormal vital signs;
Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;
Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2;
General infection or local severe infection, or other infection that is not controlled;
Dysfunction in lung, heart, kidney and brain;
Severe autoimmune diseases;
Other symptoms that are not applicable for CAR-T.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Li, M.D., Ph.D.
Phone
+86-139-7003-8386
Email
yx021021@sina.com
Facility Information:
Facility Name
The First Affiliated Hospital of Nangchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li, M.D., Ph.D.
Phone
+86-139-7003-8386
Email
yx021021@sina.com
12. IPD Sharing Statement
Learn more about this trial
Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
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