OVERVIEW
Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up
PROTOCOL SUMMARY
Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Relapsed and Refractory Multiple Myeloma
Gender
N/A
Date
December 2019 - October 2024
Study Type
Interventional
Study Phase
Phase 1
Product
anitocabtagene-autoleucel
Eligibility information
Inclusion criteria
- Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease
- Documented measurable disease
- Adequate organ function
- Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1
Exclusion criteria
- Plasma Cell Leukemia or History of Plasma Cell Leukemia
- Patients with a history of severe hypersensitivity to DMSO should be excluded
- Contraindication to fludarabine or cyclophosphamide
- Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities
- Active central nervous system disease involvement by malignancy or active CNS pathology
Locations
Locations (4)
Advanced Cellular Therapeutics Facility, DCAM 0800A
Chicago, Illinois, United States, 60637
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial