Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL
Recruiting now · Phase 1/Phase 2
Conditions studied: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, T - Cell Lymphoma, PTCL
In brief
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
Key facts
- Study ID
- NCT06874946
- Run by
- Peking University People's Hospital
- People needed
- 30
- Starts
- 2025-02-14
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-07
Who can join
Age: 3 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The 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 (inclusive).
- 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 (R/R T-ALL/NHL) confirmed at screening and meeting at least one of the following criteria:
- Bone marrow involvement: Morphologic examination shows ≥5% lymphoblasts, and/or
- Cerebrospinal fluid (CSF) involvement: Tumor cells detected in CSF, and/or
- Extramedullary disease: Presence of measurable lesions (lymph node/mass ≥1.5 cm in axial diameter or extranodal lesion ≥1 cm in axial diameter).
- CD5 expression: Tumor cells in bone marrow, peripheral blood, or CSF are CD5-positive by flow cytometry, and/or lymph node/mass or extranodal lesions are CD5-positive by pathology.
- Adequate major organ function, defined as:
- AST and ALT ≤5× upper limit of normal (ULN).
- Total bilirubin ≤2× ULN.
- Renal function: Serum creatinine clearance ≥60 mL/min (Cockcroft-Gault formula) or creatinine ≤1.5× ULN.
- Blood oxygen saturation >92%.
- Reproductive health requirements:
- 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 (pre-menopausal or within 2 years post-menopause) must have a negative blood pregnancy test at screening.
You may not qualify if…
- History of central nervous system (CNS) diseases, including but not limited to:
- Epilepsy
- Paralysis
- Aphasia
- Stroke
- Severe brain injury
- Dementia
- Parkinson's disease
- Neuropathy
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:
- Crohn's disease
- Rheumatoid arthritis
- Systemic lupus erythematosus (SLE)
- Systemic sclerosis
- Inflammatory bowel disease (IBD)
- Vasculitis
- Psoriasis
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.
- Positive virological or infectious disease markers, including:
- Hepatitis B virus (HBV): Subjects with positive HBsAg or HBcAb-positive at screening must have undetectable HBV DNA in peripheral blood to be eligible; otherwise, they should be excluded.
- Hepatitis C virus (HCV): Subjects with positive HCV antibodies and detectable HCV RNA should be excluded.
- Human immunodeficiency virus (HIV) antibody-positive subjects should be excluded.
- Cytomegalovirus (CMV) DNA test-positive subjects should be excluded.
- Epstein-Barr virus (EBV) DNA test-positive subjects should be excluded.
- Positive serological or non-specific antibodies for Treponema pallidum (syphilis).
Where it is running
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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