Health Trials

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 group

Locations

4
Beijing GoBroad Hospital102200, BeijingBeijing Municipality, China
湛江中心人民医院524000, ZhanjiangGuangdong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine200025, ShanghaiShanghai Municipality, China
Shanghai Liquan Hospital200435, ShanghaiShanghai Municipality, China

Sponsors and collaborators

Beijing GoBroad Hospital

Lead sponsor

Ruijin Hospital

Collaborator

Shanghai Liquan Hospital

Collaborator

Source ClinicalTrials.gov