C-CAR011 Treatment in Subjects With ALL After HSCT

Study Overview
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Brief Summary
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This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT

Detailed Description
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A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10^6CAR+T cells/kg

Official Title
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A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）

Conditions
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Acute Lymphoblastic Leukemia(ALL)

Intervention / Treatment
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* Biological: C-CAR011


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 15-65 years old, male or female. Volunteered to participate in this study and signed informed consent. Meet the two populations above. Histologically diagnosed as CD19+B-ALL. 100% T lymphocytes of donor. Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy. Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias. Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection. Expected survival ≧ 3 months. Eastern cooperative oncology group (ECOG) performance status of 0 or 1. Exclusion Criteria: History of allergy to cellular products. Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L. The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD. Severe uncontrolled infection (mycotic, bacterial, virus and so on). Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible. The subjects were treated CART cells or DLI after HSCT. Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation. Any genetically modified T cell therapy. History of heavy drinking, drug taking or mental disease. Participated in any other clinical trial within one month prior to enrollment. Women who are pregnant or lactating or have breeding intent in 6 months. The investigators believe that any increase in the risk of the subject or interference with the results of the trial.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-CAR011<br>The amount of cells received：1.0-5.0×10^6 CAR+T cells/kg | Biological: C-CAR011<br>* CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)<br>* Other names: Anti-CD19 chimeric antigen receptor T cells (C-CAR011);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEAEs | TEAEs evaluated after C-CAR011 infusion | 2 months | 
| GVHD | GVHD evaluated after C-CAR011 infusion | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence rate | 6 and 12 months | 
| OS | Overall survival (OS) after C-CAR011 infusion | 12 months | 
| PFS | Progression free survival（PFS）after C-CAR011 infusion | 12 months | 
| Remission rate | MRD negative after C-CAR011 infusion | 2 weeks to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute lymphoblastic leukemia, Hematopoietic stem cell transplantation, Anti-CD19 chimeric antigen receptor T-cell