OncoMatch

OncoMatch/Clinical Trials/NCT05949125

Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies

Is NCT05949125 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including R-TM123 and Allo-RevCAR01-T for acute myeloid leukemia, in relapse.

Phase 1RecruitingAvenCell Europe GmbHNCT05949125Data as of May 2026

Treatment: R-TM123 · Allo-RevCAR01-TThe Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R-TM123 functions as a bridging module between Allo-RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.

Check if I qualify

Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: IL3RA overexpression (≥20% of leukemic cells expressing CD123 at any point in the course of disease)

Participants with CD123+ AML (defined as ≥20% of leukemic cells expressing CD123 at any point in the course of disease)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard or life-extending therapies

for whom all standard or life-extending therapies have failed and for whom no potentially curative therapies are available or who are intolerant to such therapies

Cannot have received: allogeneic stem cell transplantation

Exception: allowed if >2 months prior and no GvHD requiring systemic immunosuppressive therapy

Allogeneic stem cell transplantation within last 2 months or GvHD requiring systemic immunosuppressive therapy

Cannot have received: gene modified cell products

Prior treatment with gene modified cell products

Cannot have received: investigational drug substance or experimental therapy

Treatment with any investigational drug substance or experimental therapy within 4 weeks or 5 half-lives (whichever is shorter) of the substance prior to lymphodepletion

Cannot have received: anti-leukemic therapy

Treatment with anti-leukemic therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to lymphodepletion

Cannot have received: checkpoint inhibitor

Use of checkpoint inhibitors within 5 half-lives of the specific drug

Lab requirements

Kidney function

adequate renal laboratory assessments

Liver function

adequate hepatic laboratory assessments

Cardiac function

adequate cardiac function

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

Could you qualify for this trial?

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

Check if I qualify