CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age14-70
SponsorBeijing GoBroad Hospital
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- CD7 CAR-T cells infusion
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov