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OncoMatch/Clinical Trials/NCT05995028

Universal 4SCAR7U Targeting CD7-positive Malignancies

Is NCT05995028 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Universal CD7-specific CAR gene-engineered T cells for t-cell acute lymphoblastic leukemia.

Phase 1RecruitingShenzhen Geno-Immune Medical InstituteNCT05995028Data as of Jun 2026Location: China

Treatment: Universal CD7-specific CAR gene-engineered T cellsThe purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.

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Extracted eligibility criteria

Treatments studied

Other

Universal CD7-specific CAR gene-engineered T cells

Cancer type

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Acute Myeloid Leukemia

Biomarker criteria

Required: CD7 expression (positive)

Performance status

KARNOFSKY 81–100

Karnofsky performance status (KPS) score is higher than 80

Demographics

Ages 0–75

Prior therapy

Cannot have received: gene therapy

Previous treatment with any gene therapy products

Lab requirements

Blood counts

hgb≥80g/l

Kidney function

creatinine ≤ 2.5 × upper limit of normal

Liver function

ast and alt ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dl

Cardiac function

cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%

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

Frequently asked questions

Is NCT05995028 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior gene therapy disqualifies patients from enrollment.

Does this trial require CD7?

Yes, CD7 expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger and at least 0 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.

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