OncoMatch/Clinical Trials/NCT06874946
Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/LBL
Is NCT06874946 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CD5-targeted CAR-T cells for precursor t-cell lymphoblastic leukemia-lymphoma.
Treatment: CD5-targeted CAR-T cells — 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/LBL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD5 overexpression (CD5-positive by flow cytometry or pathology)
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.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational drug therapy
Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).
Cannot have received: systemic antitumor therapy
Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).
Cannot have received: extensive radiotherapy
Exception: palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study
Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study.
Lab requirements
Kidney function
Serum creatinine clearance ≥60 mL/min (Cockcroft-Gault formula) or creatinine ≤1.5× ULN
Liver function
AST and ALT ≤5× upper limit of normal (ULN); Total bilirubin ≤2× ULN
Cardiac function
QTc interval <480 ms (Fridericia correction formula); LVEF ≥50%; NYHA Class I heart failure only; no unstable angina or acute MI within 6 months; no poorly controlled hypertension; no clinically significant arrhythmias
Adequate major organ function, defined as: AST and ALT ≤5× ULN; Total bilirubin ≤2× ULN; Renal function: Serum creatinine clearance ≥60 mL/min (Cockcroft-Gault formula) or creatinine ≤1.5× ULN. QTc interval ≥480 ms (Fridericia correction formula), NYHA Class II or higher heart failure, unstable angina or acute myocardial infarction within 6 months prior to signing the ICF, LVEF <50%, poorly controlled hypertension, clinically significant arrhythmias or those requiring antiarrhythmic treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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