A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Launched by KITE, A GILEAD COMPANY · May 9, 2024

Keywords

ClinConnect Summary

This clinical trial, called iMMagine-3, is comparing a new treatment called anitocabtagene autoleucel to standard care for patients with multiple myeloma who have not responded to previous treatments. Multiple myeloma is a type of blood cancer that can come back even after treatment. In this study, researchers want to see if the new treatment can help patients live longer without their disease worsening compared to the usual therapies.

To participate in this trial, patients need to have been diagnosed with multiple myeloma and have already received 1 to 3 different treatments, including certain types of medications. Participants will be closely monitored to assess how well the treatment is working. This study is open to both men and women aged 65 and older. If you're considering participating, it's important to talk with your doctor to see if you meet the eligibility criteria and to understand what being part of this study would involve.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Documented historical diagnosis of multiple myeloma (MM)
• • Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
• • Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
• * Measurable disease at screening per IMWG, defined as any of the following:
• • Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
• • Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio
• • Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
• Key Exclusion Criteria:
• • Prior B-cell maturation antigen (BCMA)-targeted therapy
• • Prior T-cell engager therapy
• • Prior CAR therapy or other genetically modified T-cell therapy
• • Active or prior history of central nervous system (CNS) or meningeal involvement of MM
• • Cardiac atrial or cardiac ventricular MM involvement
• • History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
• • Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
• • Prior auto-SCT within 12 weeks before randomization
• • Prior allogeneic stem cell transplant (allo-SCT)
• • High-dose (eg, cumulative \> 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
• • Live vaccine ≤ 4 weeks before randomization
• • Contraindication to fludarabine or cyclophosphamide
• • History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
• • Life expectancy \< 12 weeks
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.