Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma
Eligibility Criteria
Key Inclusion Criteria:
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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:
- Plasma cell leukemia
- Non-secretory multiple myeloma
- History of Central nervous system (CNS) involvement by multiple myeloma
- Prior CAR therapy or other genetically modified T cells
- Inadequate washout from prior therapy
- Autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant
- History of active autoimmune disease
- History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment
- Recent history of other (non multiple myeloma) cancer
- Active viral, fungal, bacterial or other infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- David Geffen School of Medicine at UCLA
- H. Lee Moffitt Cancer Center
- Winship Cancer Institute, Emory University
- University of Chicago Medical Center
- Dana-Farber Cancer Institute
- Mayo Clinic
- Memorial Sloan Kettering Cancer Center
- Vanderbilt University Medical Center
- The University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Dose Escalation: 3 x 10^7 KITE-585
Dose Escalation: 1 x 10^8 KITE-585
Dose Escalation: 3 x 10^8 KITE-585
Dose Escalation: 1 x 10^9 KITE-585
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
Participants with relapsed/refractory multiple myeloma (RRMM), will receive conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day intravenous (IV) infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10^7 autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells on Day 0. Participants may also receive an optional bridging therapy at the investigator's discretion, up to 7 days before initiation of conditioning chemotherapy. Participants will then have a post-treatment assessment period and long-term follow-up period from Week 2 to Month 3 and after Month 3 to Year 15, respectively.
Participants with RRMM, will receive conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10^8 autologous anti-BCMA CAR T cells on Day 0. Participants may also receive an optional bridging therapy at the investigator's discretion, up to 7 days before initiation of conditioning chemotherapy. Participants will then have a post-treatment assessment period and long-term follow-up period from Week 2 to Month 3 and after Month 3 to Year 15, respectively.
Participants with RRMM, will receive conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10^8 autologous anti-BCMA CAR T cells on Day 0. Participants may also receive an optional bridging therapy at the investigator's discretion, up to 7 days before initiation of conditioning chemotherapy. Participants will then have a post-treatment assessment period and long-term follow-up period from Week 2 to Month 3 and after Month 3 to Year 15, respectively.
Participants with RRMM, will receive conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10^9 autologous anti-BCMA CAR T cells on Day 0. Participants may also receive an optional bridging therapy at the investigator's discretion, up to 7 days before initiation of conditioning chemotherapy. Participants will then have a post-treatment assessment period and long-term follow-up period from Week 2 to Month 3 and after Month 3 to Year 15, respectively.
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min [Grade 2 chronic kidney disease]) will receive a conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 24 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a tolerable dose of 3 x 10^7 autologous anti-BCMA CAR T cells on Day 0. Participants may also receive an optional bridging therapy at the investigator's discretion, up to 7 days before initiation of conditioning chemotherapy. Participants then had a post-treatment assessment period and long-term follow-up period from Week 2 to Month 3 and after Month 3 to Year 15, respectively.