Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies (CD5CAR-T)

iCell Gene Therapeutics

Status and phase: Unknown; Phase 1

Conditions: T-cell Acute Lymphoblastic Leukemia; T-cell Non-Hodgkin Lymphoma

Treatments: Drug: anti-CD5 CAR T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04594135

ICG190-001

Details and patient eligibility

About

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.

Full description

Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.

Enrollment: 20 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

anti-CD5 CAR T cells

Experimental group

Description:

Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg

Treatment:

Drug: anti-CD5 CAR T cells