Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances

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 non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia

Detailed Description
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Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.

Official Title
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Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances

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

Intervention / Treatment
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* Biological: CD7 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: 18 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-CD7 CAR T cells<br>anti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg. | Biological: CD7 CAR T cells<br>* Non-gene edited anti-CD7 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity (DLT) | Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | The first 28 days after infusion | 
| Type of dose-limiting toxicity (DLT) | Type of dose-limiting toxicity (DLT) | The first 28 days after infusion | 
| Adverse event by severity | Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate of ant-CD7 CAR | Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies | 1 year | 
| Progression-free survival (PFS) | Progression-free survival (PFS) | 1 year | 
| Overall survival | Overall survival | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-CD7 CAR, CD7CAR, T cell leukoma/lymphoma, T-ALL, T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma