CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma

Study Overview
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Brief Summary
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This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.

Official Title
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Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma

Conditions
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Refractory and Relapsed T Cell Lymphoma

Intervention / Treatment
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* Biological: Humanized CD7 CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry The expressions of both CD4 and CD8 are negative in patients with bone marrow involved The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points The main organ functions need to meet the following conditions: A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 > 90% Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion Expected survival exceeds 3 months Written informed consent could be acquired Exclusion Criteria: Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years Patients with uncontrolled active infection Active hepatitis B or hepatitis C infection Patients with HIV infection Severe acute or chronic graft-versus-host disease (GVHD) Participated in any other drug research clinical trials within 30 days before enrollment Prior CAR-T cells therapy within 3 months before enrollment Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment Uncontrolled other tumor Women in pregnancy, lactation or planning to become pregnant The researcher considers inappropriate to participate in this research

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD7 positive relapsed or refractory T cell lymphoma<br>Humanized CD7 CAR-T cells intravenously infused to patient with R/R T-NHL[ at a dose of (0.5- 5)x10^6 CD7 CAR-T cells/kg | Biological: Humanized CD7 CAR-T cells<br>* Patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria. | 1 year | 
| Number of Adverse Events | Adverse events are evaluated with CTCAE V5.0 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete relapse rate(CR) | Number of patients who achieved complete response after treatment by CD7 CAR-T cell. | 1 year | 
| Duration of overall response (DOR) | Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up. | 1 year | 
| Progression-free survival(PFS) | PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up. | 1 year | 
| Overall survival(OS) | OS will be assessed from the CAR-T cell infusion to death or last follow-up. | 1 year |