CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies

Phase 1

• Conditions: Refractory T-Cell Lymphoma; T Cell Lymphoma in Relapse
• Interventions: Biological: CD4 CAR T cells

• Registration Number: NCT04162340
• 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 CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.

Detailed Description

CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.

Study Timeline

• Study Start: 2019-07-11
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-19
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CD4 CAR T cells	CD4 CAR T cells	Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg

Primary Outcome Measures

Name	Time	Method
Number of adverse events after CD4 CAR T cells cell infusion	2 years particularly the first 28 days after infusion	Determine the toxicity profile of CD4 CAR T cell therapy

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	up to 6 months	Incidence of treatment-emergent adverse events
Progression-Free Survival (PFS)	up to 2 years	Progression-Free Survival (IMWG criteria)
Disease Free Survival (DFS)	up to 2 years	Disease Free Survival (DFS) (IMWG criteria)
Overall Survival (OS)	up to 2 years	overall survival

Trial Locations

Locations (2)

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

Chengdu Military General Hospital; 🇨🇳 Chengdu, Sichuan, China