CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas (NCT07022964) | Clinical Trial Compass
RecruitingPhase 1/2
CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas
China36 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
14 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 arrhythm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/Phase 2 trial and the primary outcomes being measured are dose-limiting toxicity and adverse events, what does that mean about how much is still unknown about the safety of this CD5 CAR T-cell therapy, and how does that uncertainty compare to my current treatment options?
2CAR T-cell therapies can cause serious immune reactions — given that this trial is specifically targeting CD5, which is found on healthy T-cells as well as the lymphoma cells, should I be concerned about my immune system being significantly weakened, and how would that be managed?
3This trial is for relapsed or refractory T-cell lymphoma — does my specific diagnosis, whether it's a PTCL subtype or a CTCL subtype, make me a better or worse candidate for this kind of CD5-targeted approach compared to other options you might recommend?
4CAR T-cell therapy typically requires a significant commitment — hospitalization, close monitoring, and follow-up — so what would the practical demands of this trial look like for me and my family over the weeks and months after treatment?
5Are there any standard or approved treatments I haven't yet tried that you would recommend I consider before discussing enrollment in a Phase 1/Phase 2 trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.