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

NCT07022964 | Recruiting Phase 1 DMC

• 1 other identifier: BJGBYY-IIT-LCYJ-2025-032
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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)

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD7 CAR-T infusion.

  21 days

• Adverse events (AEs)

  Total number, incidence and severity of adverse events (AEs) within 21 days of CD7 CAR-T infusion.

  21 days

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  21, 90 days

• Duration of response (DOR)

  up to 2 years

Study Arms (1)

CD5 CAR-T therapy

EXPERIMENTAL

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

Drug: CD5 CAR-T cells infusion

Interventions

CD5 CAR-T cells infusion 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.

CD5 CAR-T therapy

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Liquan Hospital: collaborator

Study Sites (3)

Beijing GoBroad Hospital

Beijing, 102200, China

RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

Shanghai Liquan Hospital

Shanghai, 200435, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous

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

Study Officials

• Tengyu Wang, Ph.D

  Beijing GoBroad Hospital, Beijing, Beijing 102200

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyang LU, Ph.D

CONTACT

86+ 18221015770; lhy13062@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dept of Hemato-Oncology and Immunotherapy

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

CN (3)