OncoMatch/Clinical Trials/NCT06874946
Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/LBL
Is NCT06874946 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06874946 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug therapy, systemic antitumor therapy, extensive radiotherapy disqualifies patients from enrollment.
Does this trial require CD5?
Yes, CD5 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger and at least 3 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify