Clinical Trial Details
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Phase IInterventional
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
Protocol: 2026P000051NCT: NCT07075185
Overview
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.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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
