Actively Recruiting
To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT
Led by Peking University People's Hospital · Updated on 2025-12-12
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 T-lymphoblastic leukaemia/lymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation
CONDITIONS
Official Title
To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legal guardian voluntarily signs informed consent.
- Male or female aged 3 years or older at consent.
- Expected survival of at least 12 weeks.
- ECOG performance status score between 0 and 2.
- Confirmed relapsed or refractory T-cell leukemia or lymphoma.
- Bone marrow shows less than 5% immature lymphocytes and positive minimal residual disease by flow cytometry.
- Tumor cells in bone marrow or blood are CD7 positive.
- Liver enzymes AST and ALT are no more than 5 times the upper limit of normal.
- Total bilirubin is no more than 2 times the upper limit of normal.
- Kidney function meets age-specific creatinine limits.
- Blood oxygen saturation above 92%.
- Participants with reproductive capacity agree to use effective contraception from consent until 2 years after study drug use; females of childbearing age have a negative pregnancy test at screening.
You will not qualify if you...
- History of central nervous system diseases such as epilepsy, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, or neuropathy.
- Any uncontrolled active infection within 4 weeks before consent or apheresis.
- Positive hepatitis B, hepatitis C, HIV, cytomegalovirus, Epstein-Barr virus, or syphilis markers with active infection.
- Significant cardiovascular diseases including prolonged QTc interval (≥480 ms), heart failure class II or higher, recent unstable angina or myocardial infarction, low left ventricular ejection fraction (<50%), uncontrolled hypertension, or serious arrhythmias.
- Allergy to any study drug components.
- Recent investigational or systemic anti-tumor treatments within 4 weeks before apheresis, except bridging chemotherapy.
- Extensive radiotherapy within 4 weeks before consent, except local radiotherapy for symptom relief.
- Recent systemic corticosteroid or immunosuppressive drug use exceeding allowed doses.
- Major surgery within 4 weeks before consent or planned during study (except routine biopsies).
- Active tuberculosis infection within 1 year before consent.
- Recent or planned live attenuated vaccines within screening period.
- Conditions affecting protocol compliance or unsuitability as judged by investigator.
- Pregnant or breastfeeding individuals.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, China, 100044
Actively Recruiting
Research Team
J
Jing Liu
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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