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

A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma

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.

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