Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

December 31, 2025

Study Completion Date

December 22, 2027

Conditions
Multiple Myeloma
Interventions
BIOLOGICAL

TAA-specific CTLs

"Groups A and B only: Each patient will receive 2 infusions at the same dose, 14 days apart, according to the following dosing schedules:~Dose Level One:~Day 0: 5 x 10\^6 cells/m2 and Day 14: 5 x 10\^6 cells/m2~Dose Level Two:~Day 0: 1 x 10\^7 cells/m2 and Day 14: 1 x 10\^7 cells/m2~Dose Level Three:~Day 0 2 x 10\^7 cells/m2 and Day 14 2 x 10\^7 cells/m2~If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion."

BIOLOGICAL

TAA-specific CTLs- fixed dose

"Fixed dose of 2 infusions of 2 x 10\^7 cells/m2 administered 2 weeks apart.~If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion."

Trial Locations (3)

77030

RECRUITING

Harris Health Ben Taub Hospital, Houston

RECRUITING

Harris Health Smith Clinic, Houston

RECRUITING

Houston Methodist Hospital, Houston

All Listed Sponsors
collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

Harris County Hospital District

OTHER_GOV

lead

Baylor College of Medicine

OTHER