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OncoMatch/Clinical Trials/NCT06197672

Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant

Is NCT06197672 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD4CAR for acute myeloid leukemia.

Phase 1RecruitingHuda SalmanNCT06197672Data as of May 2026

Treatment: CD4CAR — This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory AML. The study will evaluate safety in this patient population and also the presence of efficacy signal described by elimination of residual disease to qualify patients for stem cell transplant.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: CD4 positive

Prior therapy

Min 1 prior line

Must have received: intensive induction chemotherapy — first line

must have failed standard induction/ first line treatment such as intensive induction

Must have received: hypomethylating agent plus venetoclax (azacitidine, venetoclax) — first line

less intensive hypomethylation and venetoclax first line

Cannot have received: gene therapy

Any previous treatment with any gene therapy products

Lab requirements

Kidney function

Creatinine clearance > 60ml/min (or otherwise non clinically significant, per study investigator)

Liver function

ALT/AST < 3 x ULN; Bilirubin < 2 x ULN

Cardiac function

Ejection fraction ≥50% by echocardiogram

Creatinine clearance of > 60ml/min (or otherwise non clinically significant, per study investigator); alanine aminotransferase/ aspartate aminotransferase ALT/AST < 3 x ULN; Bilirubin < 2 x ULN (UPPER LIMIT OF NORMAL); Adequate echocardiogram with EJECTION FRACTION, EF, of ≥50%

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

US trial sites

  • University of Miami Sylvester Comprehensive Cancer Center · Miami, Florida
  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, Indiana
  • Riley Hospital for Children · Indianapolis, Indiana
  • The University of Texas MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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