Anti-BCMA CAR-T Cells for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an open-label study to determine the safety of anti-B-cell maturation antigen (BCMA) Chimeric antigen receptor T-cell (CAR T) therapy in participants with Relapsed or Refractory Multiple Myeloma (RRMM).
Will I have to stop taking my current medications?
The trial requires that you stop taking anti-multiple myeloma therapy, including systemic corticosteroids, at least 14 days before starting the chemotherapy that prepares you for the CAR-T cell treatment.
Is Anti-BCMA CAR-T cell therapy safe for humans?
Anti-BCMA CAR-T cell therapy has shown promising safety results in clinical trials for multiple myeloma, with some patients experiencing reversible side effects like cytokine-release syndrome (a condition where the immune system becomes overly active). Early trials have demonstrated that this treatment can be safe and effective, but ongoing research is needed to fully understand its safety profile.12345
How is the Anti-BCMA CAR-T cell treatment different from other treatments for multiple myeloma?
The Anti-BCMA CAR-T cell treatment is unique because it uses genetically modified T cells to specifically target and destroy multiple myeloma cells by recognizing the BCMA protein on their surface. This approach is different from traditional treatments as it offers a targeted mechanism of action, potentially leading to better outcomes for patients with relapsed or refractory multiple myeloma.12678
What data supports the effectiveness of the Anti-BCMA CAR-T Cells treatment for Multiple Myeloma?
Research shows that Anti-BCMA CAR-T cells have a high response rate in treating multiple myeloma, with 81% of patients responding to the treatment and 63% achieving a very good partial response or complete response. This treatment has shown substantial activity against heavily treated relapsed/refractory multiple myeloma, encouraging further development of CAR T-cell therapies for this condition.1291011
Who Is on the Research Team?
Thomas Martin, MD
Principal Investigator
University of California, San Francisco
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. They must have tried at least three therapies, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. Participants need good organ function and can't be pregnant or breastfeeding. People with active CNS issues, autoimmune diseases needing recent treatment, uncontrolled illnesses, another cancer (except certain skin cancers), or active hepatitis B/C are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and CAR-T Cell Manufacturing
Participants undergo apheresis for collection of autologous peripheral blood mononuclear cells to generate CAR-T cells
Lymphodepleting Chemotherapy
Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by 2-5 days of rest
CAR-T Cell Infusion
A single infusion of anti-BCMA CAR-T cells is administered
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are followed up annually for up to 15 years to monitor overall survival and long-term effects
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Fludarabine
- Manufactured Anti-BCMA CAR-T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Martin, MD
Lead Sponsor
University of California, Davis
Collaborator
Eugia Pharma Specialities Limited
Collaborator
Actavis Inc.
Industry Sponsor
Brent Saunders
Actavis Inc.
Chief Executive Officer since 2014
B.A. from the University of Pittsburgh, MBA and J.D. from Temple University
Nesli Basgoz
Actavis Inc.
Chief Medical Officer since 2014
MD from McGill University