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

Phase 1

• Conditions: T-cell Acute Lymphoblastic Lymphoma; T-cell Non-Hodgkin Lymphoma; T-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: CD7 CAR T cells

• Registration Number: NCT04934774
• Lead Sponsor: iCell Gene Therapeutics

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

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 Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-02-27
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-19
• Last Update Submitted: 2021-06-19
• Study First Posted: 2021-06-22
• Last Update Posted: 2021-06-22
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Signed written informed consent; Patients volunteer to participate in the research
2. Diagnosis is mainly based on the World Health Organization (WHO) 2008
3. Patients have exhausted standard therapeutic options
4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
5. Female must be not pregnant during the study

Exclusion Criteria

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
4. Any drug used for GVHD must be stopped >1 week

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
anti-CD7 CAR T cells	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.

Primary Outcome Measures

Name	Time	Method
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
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China