Official Title: A Phase I Study of Adoptive Immunotherapy for Advanced B-Cell Maturation Antigen BCMA Multiple Myeloma With Autologous CD4 and CD8 T Cells Engineered to Express a BCMA-Specific Chimeric Antigen Receptor
Status: COMPLETED
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment T cells are a type of white blood cell and a major component of the immune system T-cells that have been genetically modified in the laboratory express BCMA and may kill cancer cells with the protein BCMA on their surface Giving chemotherapy before BCMA CAR-T cells may reduce the amount of disease and to cause a low lymphocyte white blood cell count in the blood which may help the infused BCMA CAR-T cells survive and expand
Detailed 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
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
Study Oversight
Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID
Type
Domain
Link
NCI-2017-01932
REGISTRY
None
None
9762
OTHER
None
None
RG9217023
OTHER
None
None
P01CA018029
NIH
Fred HutchUniversity of Washington Cancer Consortium