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OncoMatch/Clinical Trials/NCT06633354

Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

Is NCT06633354 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies CD5 CAR T-cells for t-acute lymphoblastic leukemia.

Early Phase 1RecruitingZhejiang UniversityNCT06633354Data as of Jun 2026Location: China

Treatment: CD5 CAR T-cellsA Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL

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Extracted eligibility criteria

Treatments studied

Other

CD5 CAR T-cells

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

Min 1 prior line

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.

Frequently asked questions

Is NCT06633354 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior gene therapy, systemic corticosteroids, small molecule targeted therapy disqualifies patients from enrollment.

Does this trial require CD5?

Yes, CD5 overexpression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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