Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies

Study Overview
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Brief Summary
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This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.

Detailed Description
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Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.

Official Title
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Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies

Conditions
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T-cell Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: anti-CD5 CAR T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent; Patients volunteer to participate in the research Diagnosis is mainly based on the World Health Organization (WHO) 2008 Patients have exhausted standard therapeutic options Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks Female must be not pregnant during the study Exclusion Criteria: Patients declining to consent for treatment Prior solid organ transplantation Potentially curative therapy including chemotherapy or hematopoietic cell transplant Any drug used for GVHD must be stopped >1 week

Ages Eligible for Study
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Minimum Age: 8 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-CD5 CAR T cells<br>Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg | Drug: anti-CD5 CAR T cells<br>* anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events after anti-CD5 CAR T cells cell infusion | Determine the toxicity profile of anti-CD5 CAR T cell therapy | 2 years particularly the first 28 days after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent adverse events | up to 6 months | 
| Disease Free Survival (DFS) | Disease Free Survival (DFS) | up to 2 years | 
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) | up to 2 years | 
| Overall Survival (OS) | Overall Survival (OS) | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-CD5 CAR, T cell leukemia/lymphoma, T-ALL