Actively Recruiting
Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL
Led by Peking University People's Hospital · Updated on 2026-05-07
30
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
H
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/NHL
CONDITIONS
Official Title
Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or guardian understands and voluntarily signs the informed consent form (ICF).
- Male or female, aged 3-70 years at the time of signing the ICF.
- Expected survival of at least 12 weeks.
- ECOG performance status of 0-2 at the time of ICF signing.
- Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia/lymphoma confirmed at screening with at least one of: bone marrow involvement (\u22655% lymphoblasts), cerebrospinal fluid involvement (tumor cells detected), or measurable extramedullary lesions.
- Tumor cells are CD5-positive by flow cytometry or pathology.
- Adequate major organ function: AST and ALT \u22645 times upper limit of normal, total bilirubin \u22642 times upper limit of normal, renal function with creatinine clearance \u226560 mL/min or creatinine \u22641.5 times upper limit of normal.
- Blood oxygen saturation above 92%.
- Fertile men and women of childbearing potential must agree to use effective contraception from ICF signing until 2 years after study drug administration.
- Women of childbearing potential must have a negative blood pregnancy test at screening.
You will not qualify if you...
- History of central nervous system diseases such as epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or neuropathy.
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to ICF signing, including Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, inflammatory bowel disease, vasculitis, or psoriasis.
- Presence of uncontrolled active infection at ICF signing or within 4 weeks prior to apheresis needing treatment.
- Positive tests for hepatitis B (unless undetectable HBV DNA), hepatitis C, HIV, cytomegalovirus, Epstein-Barr virus, or syphilis.
- Clinically significant cardiovascular diseases including prolonged QTc interval, heart failure (NYHA Class II or higher), recent unstable angina or heart attack, reduced left ventricular function, poorly controlled hypertension, or serious arrhythmias.
- History of severe allergy to any study drug components.
- Recent investigational drug therapy or systemic antitumor treatment within 4 weeks before apheresis.
- Extensive radiotherapy within 4 weeks prior to ICF signing, except limited palliative radiotherapy.
- Unresolved prior therapy toxicity above Grade 1 except hair loss or pigmentation.
- Use of systemic corticosteroids or immunosuppressive therapy above specified doses within 3 days prior to apheresis or during the study, except certain low-dose or localized steroids.
- Major surgery within 4 weeks prior to ICF signing or planned during the study.
- History of active tuberculosis within 1 year prior to ICF signing.
- History of other primary cancers within 5 years, except treated carcinoma in situ of the cervix or localized skin cancers.
- Receipt of live or inactivated vaccines within 4 weeks before ICF signing or planned during screening.
- Any condition judged by the investigator to interfere with study adherence or suitability.
- Pregnancy or breastfeeding.
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, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
M
MENG LV, MD PhD
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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