Health TrialsbyHealthPanel

Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies (1b Dose Expansion)

ConditionsAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvenCell Europe GmbH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Up to third relapse 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.

Without prior myeloproliferative neoplasm (MPN) or MDS/MPN (including leukemic transformation of MPN, "blast phase", and "accelerated phase" MPN), and without hyperproliferative disease requiring cytoreductive treatment within 4 weeks from the screening or with WBC above ULN at screening.

Exceptions to minimum CD123 expression are not allowed. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy of at least 3 months in the judgment of the investigator. 6. Adequate renal and hepatic laboratory assessments. 7. Adequate cardiac function. 8. Long-term central venous access existing (e.g., tunneled CV catheter or port-system) or willing to have such a device inserted to ensure continuous R-TM123 administration.

Disqualifiers

Acute promyelocytic leukemia (t15;17) or myeloproliferative neoplasm (MPN) per WHO 2022 diagnostic criteria.

AML with only extramedullary manifestations (e.g., chloroma, primary myeloid sarcoma).

Active manifestation of AML in the central nervous system.

Bone marrow failure syndromes.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cyclophosphamide (Non-IMP, Lymphodepletion)

    Other intervention

    Intravenous infusion over 3 days (d-5 to d-3)

  • Fludarabine (Non-IMP, Lymphodepletion)

    Other intervention

    Intravenous infusion over 3 days (d-5 to d-3)

  • R-TM123

    Drug

    Intravenous infusion over 20 days

  • Allo-RevCAR01-T

    Drug

    Allo-RevCAR01-T will be administered as IV infusion on Treatment Day 1

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Allo-RevCAR01-T-CD123 treatmentExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Safety and tolerability

Incidence and intensity of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), tumor lysis syndrome, and graft versus host disease (GvHD), which will be graded according to widely accepted specialized criteria

Time frame
At the end of cycle 1 (in total 28 days, given no treatment interruptions)

Secondary outcomes

1

Response rate to consolidation treatment cycles

* Complete remission (CR, CRc, CRh, CRi, CRMRDneg, CRMRDpos) * Morphologic leukemia free state (MLFS), * Partial remission (PR) * Overall response rate (ORR) * Best response rate * Duration of response

Time frame
At any timepoint until end of study (6 months after the end of last R-TM123 administration)
2

Survival rates

* Progression free survival * Overall survival

Time frame
At end of study visit (6 months after the end of last R-TM123 administration)
3

Evidence of biological and clinical activity including best response rate

* Complete remission (CR, CRh, CRi, CRMRDneg, CRMRDpos) * Morphologic leukemia free state (MLFS) * Partial remission (PR) * Overall response rate (ORR) * Best response rate * Duration of response * PFS * OS

Time frame
At any timepoint until end of study (6 months after the end of last R-TM123 administration)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AvenCell Europe GmbH

Lead sponsor

Allucent (NL) BV

Collaborator

Source ClinicalTrials.gov
Apply now