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

Refractory T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162340
• Other study ID #: ICG155-001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 11, 2019
• Est. completion date: October 2021

Study information

• Verified date: May 2021
• Source: iCell Gene Therapeutics
• Contact: Kevin Pinz, MS
• Phone: 6315386218
• Email: kevin.pinz[@]icellgene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Refractory T-Cell Lymphoma
• T Cell Lymphoma in Relapse

Intervention

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

Locations

Country	Name	City	State
China	Chengdu Military General Hospital	Chengdu	Sichuan
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
iCell Gene Therapeutics	iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events	up to 6 months
Secondary	Disease Free Survival (DFS)	Disease Free Survival (DFS) (IMWG criteria)	up to 2 years
Secondary	Progression-Free Survival (PFS)	Progression-Free Survival (IMWG criteria)	up to 2 years
Secondary	Overall Survival (OS)	overall survival	up to 2 years