Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07022964

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

T-Cell Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type T-cell Lymphoma (PTCL and CTCL)

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing GoBroad Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Time frame: 21 days

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

  2. Adverse events (AEs)

    Time frame: 21 days

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

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 21, 90 days

    The assessment of ORR by dose group at 21 and 90 Days after CD7 CAR T infusion.

  2. Duration of response (DOR)

    Time frame: up to 2 years

    DOR is defined as the date when CR response criteria are first met to the date of relapse or death caused by T-NHL in the absence of documented relapse

Study contacts

Contact information is provided by the study sponsor or research team.

Haiyang LU, Ph.D

CONTACT

[email protected]

86+ 18221015770

Sponsors and collaborators

Lead sponsor

Beijing GoBroad Hospital

Other

Collaborators

  • Ruijin Hospital
  • Shanghai Liquan Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.