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

NCT ID: NCT04594135

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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T-cell Acute Lymphoblastic Leukemia T-cell Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anti-CD5 CAR T cells

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

Group Type EXPERIMENTAL

anti-CD5 CAR T cells

Intervention Type DRUG

anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells

Interventions

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anti-CD5 CAR T cells

anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iCAR Bio Therapeutics Ltd.

INDUSTRY

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

iCell Gene Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongyu Zhang, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Shenzhen Hospital, China

Locations

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Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kevin G Pinz, MS

Role: CONTACT

6315386218

Facility Contacts

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Hongyu Zhang, MD/PhD

Role: primary

Other Identifiers

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ICG190-001

Identifier Type: -

Identifier Source: org_study_id

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