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Recruiting NCT07022964

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

Phase I / Phase II Interventional T-Cell Non-Hodgkin Lymphoma T-cell Lymphoma (PTCL and CTCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD5 CAR-T cells infusion.
Who it may be relevant to
Registry conditions: T-Cell Non-Hodgkin Lymphoma, T-cell Lymphoma (PTCL and CTCL). Basic parameters: 14 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: 21 days]
  • Adverse events (AEs) [Time frame: 21 days]
Secondary outcome measures (2)
  • Objective Response Rate (ORR) [Time frame: 21, 90 days]
  • Duration of response (DOR) [Time frame: up to 2 years]

Eligibility criteria

Inclusion Criteria (Patients who met all the inclusion criteria were eligible for enrolment):

  • 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 who fulfil any of the following criteria may not be enrolled):

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Beijing GoBroad Hospital — Beijing
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
  • Shanghai Liquan Hospital — Shanghai

Identifiers

NCT: NCT07022964 · BJGBYY-IIT-LCYJ-2025-032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗