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.
Treatment: R-TM123 · Allo-RevCAR01-T — The 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 qualifyExtracted 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.
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