CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas

NCT ID: NCT07022964

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-06-01

Brief Summary

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

Conditions

T-Cell Non-Hodgkin Lymphoma; T-cell Lymphoma (PTCL and CTCL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD5 CAR-T therapy

Enrolled patients were treated with anti-CD7 CAR-T cells, with or without allo-HSCT bridging.

Group Type: EXPERIMENTAL

CD5 CAR-T cells infusion

Intervention Type: DRUG

Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

Interventions

CD5 CAR-T cells infusion

Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or chemotherapy);
• Male or female, age 14-70;
• Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
• life expectancy is at least 60 days;
• Subjects should be capable of understanding and signing the informed consent form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately.

Exclusion Criteria

• Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load >30%; patients without history of allogeneic HSCT and peripheral blood tumour load >30%;
• Intracranial hypertension or cerebral impaired consciousness;
• Symptomatic heart failure or severe arrhythmia;
• Symptoms of severe respiratory failure;
• With other types of malignancy;
• Diffuse intravascular coagulation;
• Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
• With sepsis or other uncontrollable infection;
• Suffering from uncontrollable diabetes mellitus;
• Severe mental disorders;
• Have significant intracranial lesions on cranial MRI;
• Organ transplantation (excluding haematopoietic stem cell transplantation) history;
• Female patients (patients of childbearing potential) with positive blood HCG test;
• Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Shanghai Liquan Hospital

OTHER

Sponsor Role: collaborator

Beijing GoBroad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing Pan

Director of Dept of Hemato-Oncology and Immunotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tengyu Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beijing GoBroad Hospital, Beijing, Beijing 102200

Locations

Beijing GoBroad Hospital

Beijing, , China

Site Status: RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Shanghai Liquan Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyang LU, Ph.D

Role: CONTACT

lhy13062@rjh.com.cn

86+ 18221015770

Facility Contacts

Tengyu Wang, Ph.D

Role: primary

miaosc@gobroadhealthcare.com

86+18831006667

Haiyang LU, Ph.D

Role: primary

lhy13062@rjh.com

86+18221015770

Su LI, Ph.D

Role: primary

86+4000215005

Other Identifiers

BJGBYY-IIT-LCYJ-2025-032

Identifier Type: -

Identifier Source: org_study_id