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Recruiting

CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas

NCT06925464 · Beijing GoBroad Hospital
In plain English

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Official title
A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas
About this study
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.
Study design
Enrollment target: 36 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-04-01
Estimated completion: 2027-04-01
Last updated: 2025-05-13
Interventions
Drug: CD7 CAR-T cells infusion
Primary outcomes
  • Dose-limiting toxicity (DLT) (21 days)
  • Adverse events (AEs) (21 days)
Sponsor
Beijing GoBroad Hospital · other
With: Ruijin Hospital, Shanghai Liquan Hospital
Contacts & investigators
ContactHaiyang LU, Ph.D · contact · lhy13062@rjh.com.cn · 86+ 18221015770
All locations (4)
Beijing GoBroad HospitalRecruiting
Beijing, Beijing Municipality, China
湛江中心人民医院Recruiting
Zhanjiang, Guangdong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Shanghai Liquan HospitalRecruiting
Shanghai, Shanghai Municipality, China