CAR T-Cell Therapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will test the safety of the study treatment, MCARH109, at different doses, to see which dose is safest in people, and to look for any good and bad effects of this treatment. The study treatment could stop the growth of the cancer, but it could also cause side effects.
Will I have to stop taking my current medications?
The trial requires a 14-day period without myeloma therapies before certain procedures, so you may need to stop some medications. It's best to discuss your specific medications with the trial team to understand what changes might be necessary.
Is GPRC5D-targeted CAR T-cell therapy safe for humans?
How is the treatment MCARH109 different from other treatments for multiple myeloma?
MCARH109 is a unique CAR T-cell therapy that targets the GPRC5D protein on multiple myeloma cells, offering a new approach for patients who have relapsed or are resistant to existing BCMA-targeting therapies. This treatment has shown promising results, with all patients in a study responding to the therapy.12346
What data supports the effectiveness of the treatment MCARH109, a GPRC5D-targeted CAR T-cell therapy, for multiple myeloma?
Research shows that GPRC5D-targeted CAR T-cell therapy has been effective in treating patients with relapsed or resistant multiple myeloma, with one study reporting a 100% response rate in 10 patients. This suggests that targeting the GPRC5D protein on myeloma cells can be a promising approach for this condition.12346
Who Is on the Research Team?
Sham Mailankody, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with multiple myeloma that's come back or hasn't responded to treatment, including a proteasome inhibitor, an immunomodulatory drug, and a CD38 monoclonal antibody. They should have had at least three prior treatments and meet specific health criteria like good organ function and blood counts.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and T Cell Modification
Patients undergo leukapheresis for T cell enrichment, activation, and genetic modification using a lentiviral vector encoding a GPRC5D targeted CAR (MCARH109).
Conditioning Chemotherapy
Participants receive conditioning chemotherapy prior to T cell infusion.
T Cell Infusion
Modified T cells are infused 2-7 days following completion of conditioning chemotherapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including bone marrow aspirate and biopsy at approximately 1 and 4 weeks following the T cell infusion.
Long-term Follow-up
Participants are observed for a minimum of 30 days before dose escalation and monitored for up to 1 year to determine the maximum tolerated dose.
What Are the Treatments Tested in This Trial?
Interventions
- MCARH109
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor