Clinical Trial 24145

• Overview

  Study Title:

  A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-BCMA CAR-T Cells in Patients with Relapsed and Refractory Multiple Myeloma

  Summary:

  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.

  Objective:

  The primary objective is: To determine the safety, tolerability, maximum tolerated dose (MTD), and/or recommended Phase 2 dose (RP2D) of KLN-1010 Secondary: To characterize the pharmacokinetics (PK) and pharmacodynamics of KLN-1010 To determine the preliminary antitumor activity of KLN-1010 Exploratory: To evaluate biomarkers relating to mechanism of action, immune response, safety, and activity following administration of KLN-1010 To evaluate the immunophenotype of chimeric antigen receptor (CAR) and endogenous T cells To describe determinants of response based on patient baseline characteristics, characteristics of myeloma, or drug product attributes

• Treatments

  Therapies:

  Cell Therapy; Gene Therapy

  Medications:

  KLN-1010 ()

• Inclusion Criteria

  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
  • Other criteria may apply

• Exclusion Criteria

  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
  • Other exclusions may apply

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