Clinical trial · Interventional
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
NCT07075185CI-TRIAL-00124581inMMyCARrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Protein Disorders | — | UNRESOLVED | — |
| Gene Therapy | — | UNRESOLVED | — |
| Hematologic Disease and Disorders | — | UNRESOLVED | — |
| Hemostatic Disorders | — | UNRESOLVED | — |
| Immune System Disease | — | UNRESOLVED | — |
| Immunoproliferative Disorders | — | UNRESOLVED | — |
| Lymphoproliferative Disorders | — | UNRESOLVED | — |
| Multiple Myeloma in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Multiple Myeloma Progression | — | UNRESOLVED | — |
| Myeloma Multiple | Multiple Myeloma | ALIAS | 0.90 |
| Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KLN-1010 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KLN-1010
- description
- Drug: KLN-1010 specified dose given once
- interventionNames
- Drug: KLN-1010
Primary outcomes (1)
- measure
- Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose
- timeFrame
- Up to 15 years from dosing of KLN-1010
- description
- All adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria
Secondary outcomes (7)
- measure
- Pharmacokinetics of KLN-1010 after dosing.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.