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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kite, A Gilead Company
• Treatments: Cyclophosphamide; Fludarabine

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