Changeflow GovPing Healthcare & Life Sciences Phase 1 CAR T-Cell Trial for Kappa Myeloma Anti...
Routine Notice Added Final

Phase 1 CAR T-Cell Trial for Kappa Myeloma Antigen in Relapsed/Refractory Multiple Myeloma

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Summary

The National Institutes of Health has registered a Phase 1 clinical trial (NCT07541391) evaluating the safety and efficacy of escalating doses of autologous PMCC-COE-KMA CAR T-cells in patients with relapsed/refractory multiple myeloma expressing the kappa myeloma antigen. The trial will assess CAR T-cell therapy produced using lentiviral vectors following lymphodepleting conditioning chemotherapy. This registry entry documents an investigational Phase 1 study and does not represent approval of the therapy or establishment of new regulatory obligations.

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What changed

This document adds a new clinical trial registration entry to ClinicalTrials.gov for a Phase 1 study of CAR T-cell therapy targeting the kappa myeloma antigen in patients with relapsed or refractory multiple myeloma. The registry entry provides study metadata including the phase classification, intervention type, and condition studied.

For compliance and regulatory affairs teams monitoring clinical development activity, this registry entry indicates that an investigational CAR T-cell product is entering early-phase clinical evaluation. Sponsors and investigators conducting similar cellular therapy programs for multiple myeloma may wish to monitor this trial for competitive intelligence purposes, but the registration does not impose any new compliance obligations on external parties.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed/Refractory Disease

Phase 1 NCT07541391 Kind: PHASE1 Apr 21, 2026

Abstract

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: Relapsed/Refractory Multiple Myeloma

Interventions: PMCC-COE-KMA

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Cellular therapy development Biologic manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Healthcare Medical Devices

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