Clinical Trial 19331

Cancer Type:
Interventions:KITE-585; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Frederick Locke

Overview

Study Title

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

Summary

To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell product targeting a protein commonly found on myeloma cells called BCMA. Participants will be given a 3 day course of chemotherapy followed by a single infusion of KITE-585.

Objective

Primary Objective: The primary objective of this study is to evaluate the safety and tolerability of KITE-585, as measured by the incidence of DLTs as outline in Section 9.6.1. Secondary Objectives: The secondary objective of this study is to gain insight into additional features of safety and efficacy of KITE-585 in subjects with both normal and moderately compromised renal function, including depth and durability of response, minimal residual disease (MRD), survival, and toxicity of the regimen.

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
  • Additional criteria may apply

  • Exclusion Criteria

  • Plasma cell leukemia
  • Non-secretory multiple myeloma
  • Active or prior history of central nervous system (CNS) or meningeal involvement by malignant plasma cells.
  • 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
  • Additional criteria may apply