Actively Recruiting
To Observe the CD7-targeted CAR-T Therapy in the Treatment of r/r PTCL
Led by Peking University People's Hospital · Updated on 2025-08-27
18
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL.
CONDITIONS
Official Title
To Observe the CD7-targeted CAR-T Therapy in the Treatment of r/r PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 80 years
- Diagnosed with peripheral T-cell lymphoma according to NCCN 2022 guidelines
- Relapsed or refractory PTCL after at least one prior systemic treatment
- Histologically confirmed CD7 positive
- At least one evaluable tumor lesion with metabolic activity on enhanced CT and PET/CT
- Neutrophil count at least 1.0 x 10^9/L
- Platelet count at least 75 x 10^9/L and hemoglobin at least 80 g/L without bone marrow invasion
- Platelet count at least 50 x 10^9/L and hemoglobin at least 60 g/L with bone marrow invasion
- Creatinine clearance over 60 ml/min
- Serum total bilirubin no more than 1.5 times the upper normal limit
- Serum ALT and AST no more than 3 times the upper normal limit
- Left ventricular ejection fraction at least 50%
- Estimated survival time over 3 months
- ECOG performance status 0 or 1
- Voluntary participation with signed informed consent
You will not qualify if you...
- Primary cutaneous T-cell lymphoma including mycosis fungoides and Sezary syndrome
- T-lymphoblastic leukemia/lymphoma
- Primary central nervous system lymphoma or active CNS invasion
- Ongoing anti-tumor treatment with drugs not fully eliminated
- Known allergies to cellular product components
- Severe cardiac dysfunction (Class III or IV) or serious heart conditions within 12 months
- Prolonged QT interval or serious arrhythmia
- History of brain trauma, consciousness disorders, epilepsy, or cerebrovascular disease
- Uncontrolled severe active infections
- History of other primary cancers except specified
- Autoimmune diseases requiring treatment or immunosuppressive therapy
- Graft versus host disease or need for immunosuppressive therapy
- Live vaccination within 4 weeks before screening
- History of alcoholism, drug abuse, or mental illness
- Positive tests for certain viral infections including EBV, CMV, HBV, HCV, syphilis, AIDS
- Need for long-term systemic hormone treatment
- Participation in other clinical trials within 4 weeks before screening
- Pregnancy, lactation, or inability to use effective contraception
- Any condition increasing risk or interfering with study results as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaodong Mo, phd
CONTACT
N
Na Kuang
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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