Actively Recruiting
CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas
Led by Beijing GoBroad Hospital · Updated on 2025-05-13
36
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory CD7-positive T-cell lymphomas treated with standard chemotherapy with poor prognosis and no available treatment options such as HSCT or chemotherapy
- Male or female aged 14 to 70 years
- Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 to 2
- Life expectancy of at least 60 days
- Capable of understanding and signing informed consent; for ages 19-70, able to sign consent personally; for ages 14-18, legal guardian must also sign consent
You will not qualify if you...
- History of allogeneic HSCT without available peripheral blood mononuclear cells from prior donor and peripheral blood tumor load >30%, or no history of allogeneic HSCT with peripheral blood tumor load >30%
- Intracranial hypertension or impaired consciousness
- Symptomatic heart failure or severe arrhythmia
- Symptoms of severe respiratory failure
- Presence of other types of malignancy
- Diffuse intravascular coagulation
- Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value
- Sepsis or other uncontrollable infection
- Uncontrollable diabetes mellitus
- Severe mental disorders
- Significant intracranial lesions on cranial MRI
- History of organ transplantation excluding hematopoietic stem cell transplantation
- Female patients of childbearing potential with positive blood HCG test
- Hepatitis B or C infection, positive screening for AIDS or syphilis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
2
湛江中心人民医院
Zhanjiang, Guangdong, China, 524000
Actively Recruiting
3
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
4
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, China, 200435
Actively Recruiting
Research Team
H
Haiyang LU, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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