Actively Recruiting
CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas
Led by Beijing GoBroad Hospital · Updated on 2025-06-15
36
Participants Needed
3
Research Sites
156 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 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.
CONDITIONS
Official Title
CD5 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 previously treated with standard chemotherapy and lacking effective treatment options
- Male or female aged 14 to 70 years
- Eastern Cooperative Oncology Group (ECOG) Physical Status Score between 0 and 2
- Life expectancy of at least 60 days
- Ability to understand and sign informed consent (with legal guardian consent for ages 14-18) and willingness to follow study procedures
You will not qualify if you...
- History of allogeneic HSCT without available donor peripheral blood mononuclear cells and peripheral blood tumor load over 30%
- Peripheral blood tumor load over 30% without prior allogeneic HSCT
- Intracranial hypertension or impaired consciousness
- Symptomatic heart failure or severe arrhythmia
- Severe respiratory failure symptoms
- Presence of other malignancies
- Diffuse intravascular coagulation
- Serum creatinine or urea nitrogen levels 1.5 times or more above normal
- Sepsis or uncontrollable infection
- Uncontrolled diabetes mellitus
- Severe mental disorders
- Significant intracranial lesions on cranial MRI
- History of organ transplantation (excluding HSCT)
- Female patients of childbearing potential with positive blood HCG test
- Positive screening for hepatitis B, hepatitis C, AIDS, or syphilis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Beijing GoBroad Hospital
Beijing, China, 102200
Actively Recruiting
2
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Actively Recruiting
3
Shanghai Liquan Hospital
Shanghai, 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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