A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma (inMMyCAR)

Kelonia Therapeutics, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Gene Therapy

Multiple Myeloma Progression

Immunoproliferative Disorders

Hematologic Disease and Disorders

Neoplasms by Histologic Type

Neoplasm

Multiple Myeloma in Relapse

Blood Protein Disorders

Myeloma Multiple

Immune System Disease

Vascular Disorder

Hemostatic Disorders

Paraproteinemias

Lymphoproliferative Disorders

Treatments

Drug: KLN-1010

Study type

Interventional

Funder types

Industry

Identifiers

NCT07075185

KLN-001

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease
Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody
Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1
Participants must have acceptable laboratory values as defined by the protocol

Exclusion criteria

Participants must not have known central nervous system (CNS) involvement with myeloma
Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis
Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy
Participants cannot require systemic steroids for any condition