CD5 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CD5 CAR-T cells infusion
DrugApproximately 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.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: CD5 CAR-T therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity (DLT)
Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD5CAR-T infusion.
Time frame
21 days2
Adverse events (AEs)
Total number, incidence and severity of adverse events (AEs) within 21 days of CD5 CAR-T infusion.
Time frame
21 daysSecondary outcomes
1
Objective Response Rate (ORR)
The assessment of ORR by dose group at 21 and 90 Days after CD5 CAR T infusion.
Time frame
21, 90 days2
Duration of response (DOR)
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
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov