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OncoMatch/Clinical Trials/NCT07109518

uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

Is NCT07109518 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies uCD7 CART for acute myeloid leukemia (aml).

Phase 1RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT07109518Data as of May 2026

Treatment: uCD7 CARTThe aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD7 overexpression (positive)

Cytology confirmed that the tumor cells were CD7 positive.

Performance status

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

Prior therapy

Cannot have received: systemic chemotherapy

Exception: except for pretreatment; within 1 week

Systemic chemotherapy (except for pretreatment) within 1 week

Cannot have received: monoclonal antibody therapy

Exception: last infusion less than 5 half-lives or 4 weeks (whichever is shorter) at screening

For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening

Cannot have received: donor lymphocyte infusion

Exception: within 6 weeks

Received donor lymphocyte infusion (DLI) within 6 weeks

Lab requirements

Kidney function

creatine clearance >60ml/min (cockcroft and gault formula)

Liver function

serum total bilirubin ≤3 times the upper limit of normal, serum alt and ast ≤5 times the upper limit of normal range for patients without liver invasion

Cardiac function

echocardiography showing left ventricular ejection fraction (lvef) ≥50%

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

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