Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed/Refractory Disease
NCT07541391 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-04-30
Summary
The study proposed here intends to evaluate the safety and efficacy of escalating doses of autologous PMCC-COE-KMA CAR T-cells administered to patients with relapsed/refractory multiple myeloma that expresses the KMA. The PMCC-COE-KMA CAR T-cells will be produced using LV and administered to patients after lymphodepleting conditioning chemotherapy. Considering the poor prognosis of myeloma patients who have relapsed after ≥ 2 lines of therapy, combined with evidence of PMCC-COE-KMA CAR T-cell specificity, as well as the efficacy and manageable toxicity of PMCC-COE-KMA, investigators believe the potential benefits outweigh the risks of this trial.
Conditions
Interventions
- BIOLOGICAL
-
PMCC-COE-KMA
PMCC-COE-KMA is a cellular immunotherapy derived from autologous mononuclear cells that have undergone ex vivo modification to target KMA on the surface of cancer cells. Autologous T-cells are genetically programmed using LV transduction to express a CAR, which comprises an antigen recognition moiety liked to a T-cell receptor signalling domain. This makes the CAR T-cells capable of recognising KMA on tumour cells and triggering target cell destruction in a major histocompatibility complex-independent manner.
Sponsors & Collaborators
-
HaemalogiX Ltd
collaborator UNKNOWN -
Peter MacCallum Cancer Centre, Australia
lead OTHER
Principal Investigators
-
Mark Dowling, MBBS, PhD · Peter MacCallum Cancer Centre, Australia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2028-09-30
- Completion
- 2030-01-31
Countries
- Australia
Study Locations
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