Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
25

Summary

Conditions
  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To evaluate the safety of adoptive therapy with ex vivo expanded autologous CD8+ plus CD4+ T cells transduced to express a human B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) for patients with relapsed or treatment refractory multiple myeloma. SECON...

PRIMARY OBJECTIVE: I. To evaluate the safety of adoptive therapy with ex vivo expanded autologous CD8+ plus CD4+ T cells transduced to express a human B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) for patients with relapsed or treatment refractory multiple myeloma. SECONDARY OBJECTIVES: I. To determine the duration of in vivo persistence and the phenotype of long lived CAR-T cells. II. To determine the degree to which adoptively transferred T cells traffic to multiple myeloma (MM) cells in the bone marrow (BM) and function in vivo. III. To estimate the antitumor activity of adoptively transferred BCMA-specific CAR-expressing T lymphocytes (BCMA CAR-T cells). OUTLINE: This is a dose-escalation study of BCMA-specific CAR-expressing T lymphocytes. Patients undergo leukapheresis to obtain their immune cells, from which CAR-T cells are produced. A few weeks later, patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning 36-96 hours after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes intravenously (IV) over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). After completion of study treatment, patients are followed up at 60, 90, 120, 180, and 365 days and then annually up to 15 years.

Tracking Information

NCT #
NCT03338972
Collaborators
  • Juno Therapeutics, Inc.
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Damian J. Green Fred Hutch/University of Washington Cancer Consortium