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OncoMatch/Clinical Trials/NCT06420076

Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

Is NCT06420076 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CD5/CD7 CAR-T for t cell lymphoma.

Phase 1/2RecruitingEssen BiotechNCT06420076Data as of May 2026

Treatment: CD5/CD7 CAR-TChimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD7 overexpression (≥70% by flow cytometry or immunohistochemistry)

Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%)

Required: CD5 overexpression (≥70% by flow cytometry or immunohistochemistry)

Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Lab requirements

Blood counts

HGB≥70g/L (can be transfused)

Liver function

Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.

Cardiac function

No atrial fibrillation; no myocardial infarction within the past 12 months; no prolonged QT syndrome or secondary QT prolongation; no clinically significant pericardial effusion; no cardiac insufficiency NYHA III or IV

HGB≥70g/L (can be transfused); Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value. One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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