Trial of Myeloma Therapy KLN-1010 Gets FDA Green Light to Expand to US

Trial of Myeloma Therapy KLN-1010 Gets FDA Green Light to Expand to US
Trial of Myeloma Therapy KLN-1010 Gets FDA Green Light to Expand to US
Clinical Trials / Oncology January 28, 2026

Trial of Myeloma Therapy KLN-1010 Gets FDA Green Light to Expand to US

Study at a Glance
  • Trial Name: inMMyCAR
  • ID: NCT07075185
  • Sponsor: Kelonia Therapeutics
  • Therapy: KLN-1010
  • Type: Genetic Therapy
  • Target: Anti-BCMA CAR-T

A clinical trial in Australia that’s testing the genetic therapy KLN-1010 in people with hard-to-treat multiple myeloma has won regulatory approval to add new study sites in the U.S.

Phase 1 Study: inMMyCAR (NCT07075185)

The Phase 1 study, dubbed inMMyCAR (NCT07075185), will soon start enrolling patients in the U.S. It will be recruiting 40 adults with multiple myeloma that is relapsed or refractory, meaning the disease has failed to respond to previous treatments or has come back after initially responding.

The use of KLN-1010, being developed by Kelonia Therapeutics, which is sponsoring the ongoing trial, provides a distinct advantage: it does not require patients to first undergo chemotherapy before treatment.

Study Goal: All participants in the study will receive a single infusion of KLN-1010, with the main goal of evaluating safety outcomes for as long as 15 years of follow-up.

Patient Eligibility Criteria

To be eligible for the study, patients must have had at least three prior lines of treatment, involving:

  • An immunomodulatory medication
  • A proteasome inhibitor
  • An anti-CD38 antibody

Mechanism: In Vivo Anti-BCMA CAR-T

KLN-1010 is an investigational, envelope-modified, replication-incompetent, self-inactivating lentiviral vector gene therapy. Designed for in vivo generation of anti-BCMA CAR-T cells, it directly targets and modifies T cells within the patient's body to treat multiple myeloma.

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