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NCT06925464RecruitingPhase 1/2

CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas

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

Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 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 CD7 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
36 (estimated)
First submitted
6 Apr 2025
Start date
1 Apr 2025
Primary completion date
1 Apr 2026
Lead sponsor
Beijing GoBroad Hospital
NCT number
NCT06925464

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 36
  • From 1 Apr 2025 to the primary completion date, 1 Apr 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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%;
  • Organ transplantation (excluding haematopoietic stem cell transplantation) history;

Other illness

  • Intracranial hypertension or cerebral impaired consciousness;
  • Symptomatic heart failure or severe arrhythmia;
  • Symptoms of severe respiratory failure;
  • With other types of malignancy;
  • With sepsis or other uncontrollable infection;
  • Suffering from uncontrollable diabetes mellitus;
  • Severe mental disorders;
  • Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.

Lab values

  • Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;

Other

  • Diffuse intravascular coagulation;
  • Have significant intracranial lesions on cranial MRI;
  • Female patients (patients of childbearing potential) with positive blood HCG test;

Who the study is looking for

  • 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.

Age in the registry: 14 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beijing GoBroad Hospital
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BeijingChinaRecruiting
Shanghai Liquan Hospital
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ShanghaiChinaRecruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
湛江中心人民医院
Coordinator of this site? Confirm its status
ZhanjiangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.