NCT06925464 CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas
| NCT ID | NCT06925464 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing GoBroad Hospital |
| Condition | T-Cell Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06925464 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 70 Years, studying T-Cell Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06925464 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06925464 currently recruiting?
Yes, NCT06925464 is actively recruiting participants. Contact the research team at lhy13062@rjh.com.cn for enrollment information.
Where is the NCT06925464 trial being conducted?
This trial is being conducted at Beijing, China, Zhanjiang, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06925464 clinical trial?
NCT06925464 is sponsored by Beijing GoBroad Hospital. The trial plans to enroll 36 participants.