Status:
RECRUITING
CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas
Lead Sponsor:
Beijing GoBroad Hospital
Collaborating Sponsors:
Ruijin Hospital
Shanghai Liquan Hospital
Conditions:
T-Cell Non-Hodgkin Lymphoma
T-cell Lymphoma (PTCL and CTCL)
Eligibility:
All Genders
14-70 years
Phase:
PHASE1
PHASE2
Brief 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 CD7 CAR T-cell therapy. The primary objectiv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06925464
Start Date
April 1 2025
End Date
April 1 2027
Last Update
May 13 2025
Active Locations (4)
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1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
2
湛江中心人民医院
Zhanjiang, Guangdong, China, 524000
3
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
4
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, China, 200435