Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies

Study Overview
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Brief Summary
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Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells

Detailed Description
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CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.

Official Title
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Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared

Conditions
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Refractory, Relapsed, B Cell Lymphoma, B Cell Leukemia

Intervention / Treatment
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* Biological: CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: expected lifespan >3 months patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails KPS >70 for patients with lymphoma, at least one measurable lesion according to RECIST 1.1 enough function of heart, liver, kidney and bone marrow no history of severy allergy no other serious diseases that conflict with this plan no other history of malignancy no serious mental illness patients and their families members agree to participate in this clinical study and sign the Informed Consent Form Exclusion Criteria: pregnant or lactating women vevere infectious or viral diseases active hepatitis B or C viral hepatitis Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks participated in other clinical studies in the past 3 months or who have been treated with other gene products; others that other investigators consider not suitable for this clinical study

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: CAR-T cell group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>cord blood derived CAR T cells group | Biological: CAR-T cells<br>* collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg<br>* Other names: cord blood derived CAR-T cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of study related adverse events | safety of CAR-T cells | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | the proportion of patients with CR or PR | three months | 
| progression-free survival | from the date of enrollment to the first date of progression detected | one year | 
| overall survival | from the date of enrollment to the date of death | one year | 
| copy number of CAR-T | copy number of CAR-T in blood and bone marrow | six months |