OncoMatch/Clinical Trials/NCT06633354
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL
Is NCT06633354 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CD5 CAR T-cells for t-acute lymphoblastic leukemia.
Treatment: CD5 CAR T-cells — A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD5 overexpression (>90%)
CD5 expression rate was >90%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy
No CR after standard chemotherapy; The first induction reaches CR, but CR ≤ 12 months; Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments; Multiple recurrences.
Cannot have received: gene therapy
Before using any gene therapy products
Cannot have received: systemic corticosteroids
Exception: glucocorticoid physiological replacement therapy, such as prednisone < 10 mg/d or equivalent
treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone < 10 mg/d or an equivalent dose of the drug)
Cannot have received: small molecule targeted therapy
received within 72 hours of small molecule targeted therapy
Cannot have received: systemic chemotherapy
Exception: pretreatment
2 weeks received systemic chemotherapy except (pretreatment)
Cannot have received: radiation therapy
four weeks received radiotherapy
Lab requirements
Kidney function
creatinine ≤176.8 (mol/L)
Liver function
Total bilirubin ≤51 (mol/L), ALT/AST ≤ 3x ULN
Cardiac function
LVEF ≥50%
Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L); Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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