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

NCT04162340 | Unknown Phase 1

• 1 other identifier: ICG155-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

T Cell Lymphoma in Relapse; Refractory T-Cell Lymphoma

Keywords

CD4-specific CAR T; T cell leukemia; T cell lymphoma; CD4CAR

Outcome Measures

Primary Outcomes (1)

• Number of adverse events after CD4 CAR T cells cell infusion

  Determine the toxicity profile of CD4 CAR T cell therapy

  2 years particularly the first 28 days after infusion

Secondary Outcomes (4)

• Incidence of treatment-emergent adverse events

  up to 6 months

• Disease Free Survival (DFS)

  up to 2 years

• Progression-Free Survival (PFS)

  up to 2 years

• Overall Survival (OS)

  up to 2 years

Study Arms (1)

CD4 CAR T cells

EXPERIMENTAL

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

Biological: CD4 CAR T cells

Interventions

CD4 CAR T cells BIOLOGICAL

CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

CD4 CAR T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iCell Gene Therapeutics: lead
• iCAR Bio Therapeutics Ltd.: collaborator
• Peking University Shenzhen Hospital: collaborator

Study Sites (2)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

Chengdu Military General Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Leukemia, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• Hongyu Zhang, MD/PhD

  Peking University Shenzhen Hospital, China

  PRINCIPAL INVESTIGATOR

• Fang Liu, MD/PhD

  Chengdu Military Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Pinz, MS

CONTACT

6315386218; kevin.pinz@icellgene.com

Yupo Ma, MD/PhD

CONTACT

7024658132; yupo.ma@icellgene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: July 11, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)