Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma

A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects With Relapsed/Refractory Multiple Myeloma

The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell maturation antigen (BCMA), as measured by the incidence of dose-limiting toxicities (DLTs). Participants will be given a 3 day course of conditioning chemotherapy followed by a single infusion of KITE-585.

Participants with relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, ECG and echocardiogram of the heart, brain MRI, and blood draws. Eligible participants have white blood cells collected by leukapheresis. These cells are genetically modified to make the experimental treatment KITE-585. Participants receive conditioning chemotherapy prior to the KITE-585 infusion. After the KITE-585 infusion, participants will be followed for side effects and effect of KITE-585 on their myeloma. Study procedures may be performed while hospitalized and/or in the outpatient setting. Participants who received an infusion of KITE-585 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Key Inclusion Criteria:

1. Measurable relapsed or refractory myeloma as defined by the International Myeloma Working Group (IMWG) Consensus Criteria following treatment with at least 3 lines of therapy including with both a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or progressive myeloma that is refractory to a regimen containing both a PI and an IMiD.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

3. Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:

   • Absolute neutrophil count (ANC) ≥ 1,000/µL
   • Platelet count ≥ 75,000/µL
   • Absolute lymphocyte count ≥ 100/µL
   • Creatinine clearance above limits set in the protocol for each cohort
   • Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
   • Baseline oxygen saturation > 92% on room air and no clinically significant pleural effusion

Key Exclusion Criteria:

1. Plasma cell leukemia
2. Non-secretory multiple myeloma
3. History of Central nervous system (CNS) involvement by multiple myeloma
4. Prior CAR therapy or other genetically modified T cells
5. Inadequate washout from prior therapy
6. Autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant
7. History of active autoimmune disease
8. History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment
9. Recent history of other (non multiple myeloma) cancer
10. Active viral, fungal, bacterial or other infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply