Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
Condition: Relapsed/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: KITE-585; Cyclophosphamide; Fludarabine
Intervention description: A single infusion of KITE-585 autologous anti-BCMA CAR T cells; Administered intravenously; Administered intravenously
Intervention MeSH terms: Cyclophosphamide; Fludarabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose-Escalation and Dose Expansion
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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