OncoMatch/Clinical Trials/NCT05949125
Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies (1b Dose Expansion)
Official title: Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T Cells Carrying Reverse Chimeric Antigen Receptors (Allo RevCAR01 T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123
Is NCT05949125 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IL3RA expression (≥20% of leukemic cells expressing CD123 at any point in the course of disease)
CD123 positivity is 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
Cannot have received: allogeneic stem cell transplantation
Exception: within last 2 months or 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
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.
Frequently asked questions
Is NCT05949125 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplantation, gene modified cell products disqualifies patients from enrollment.
Does this trial require IL3RA?
Yes, IL3RA expression is a required biomarker for enrollment.
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 qualifyRelated pages