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

Sponsor

iCell Gene Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04934774

Collaborator

iCAR Bio Therapeutics Ltd. (Industry), Peking University Shenzhen Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
T-cell Acute Lymphoblastic Leukemia T-cell Acute Lymphoblastic Lymphoma T-cell Non-Hodgkin Lymphoma	Biological: CD7 CAR T cells	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anti-CD7 CAR T cells 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 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.

Arm

Intervention/Treatment

Experimental: anti-CD7 CAR T cells

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

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.

Outcome Measures

Primary Outcome Measures

Dose limiting toxicity (DLT) [The first 28 days after infusion]
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
Type of dose-limiting toxicity (DLT) [The first 28 days after infusion]
Type of dose-limiting toxicity (DLT)
Adverse event by severity [2 years]
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

Secondary Outcome Measures

Overall response rate of ant-CD7 CAR [1 year]
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
Progression-free survival (PFS) [1 year]
Progression-free survival (PFS)
Overall survival [1 year]
Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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