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