Clinical trial NCT03741127: Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101
Official title: Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: CAR-T cells
Lead sponsor: Poseida Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
First posted: 2018-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Subjects are enrolled in this study following completion or early discontinuation from a Poseida sponsored or supported study of P-BCMA-101 T cells and will be followed for a total of 15 years post treatment from the last P-BCMA-101 treatment. Subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (AEs) and assess long-term efficacy, and PK and quantification of P-BCMA-101 T cells. Rimiducid may be administered as indicated.

Detailed description: Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (FDA, 2006; Guidance for Industry, Gene Therapy Clinical Trials-Observing Subjects for Delayed Adverse Events), long term safety and efficacy follow up of treated subjects is required. Subjects are enrolled in this study following completion or early discontinuation from a Poseida sponsored or supported study of P-BCMA-101 T cells and will be followed for a total of 15 years post treatment from the last P-BCMA-101 treatment. Subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (AEs) and assess long-term efficacy, and PK and quantification of P-BCMA-101 T cells. Rimiducid may be administered as indicated.

Study visits Subjects will only enter this protocol after completing or discontinuing from their primary P-BCMA-101 protocol.

Once enrolled in this protocol a subject will return for regular follow-up depending on when they last received P-BCMA-101 on their primary protocol:

* Every 3 months until the end of the first year after P-BCMA-101 treatment
* Every 6 months until the end of the third year after P-BCMA-101 treatment
* Then yearly until the end of the 15th year after P-BCMA-101 treatment (ie. if a subject discontinues from their primary protocol 2 years after receiving P-BCMA-101, they will be entering this study at the beginning of the 3rd year, and will remain on this study for 13 years).

Subjects will undergo serial assessment of safety, chemistry, hematology, and disease response as specified in the Schedule of Events. Subjects will further undergo a physical exam and medical history, and anti-myeloma medications, related AEs, new malignancies, new or exacerbated clinically significant neurologic, hematologic, rheumatologic or other autoimmune disorders will be recorded. After progressive disease (PD) has been confirmed for a subject after P-BCMA-101 administration, visits may be performed remotely (AEs collected by telephone and laboratory studies completed at a local facility).

Eligibility criteria: Inclusion Criteria:

* Subjects who have received P-BCMA-101 and completed or discontinued early from a Poseida sponsored treatment protocol.
* Subject has provided informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Treatment with P-BCMA-101 through year 15
Secondary outcomes:
measure: Anti-myeloma effect of P-BCMA-101 (Response Rate)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Anti-myeloma effect of P-BCMA-101 (Time to Response)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Anti-myeloma effect of P-BCMA-101 (Duration of Response)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Anti-myeloma effect of P-BCMA-101 (Progression Free Survival)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Anti-myeloma effect of P-BCMA-101 (Overall Survival)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Concentration of P-BCMA-101 cells
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Biomarkers for P-BCMA-101 (BCMA Cells)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Biomarkers for P-BCMA-101 (Cell Count)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Biomarkers for P-BCMA-101 (Expansion)
timeFrame: Treatment with P-BCMA-101 through year 15
measure: Incidence of adverse events related to rimiducid, if indicated
timeFrame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable
measure: Effect of rimiducid on grade of P-BCMA-101-related adverse events
timeFrame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California Davis
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Wayne State - Karmanos Cancer Institute
state: Michigan
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute at Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Sponsor Executive Medical Director
name: Rajesh Belani, M.D.
role: STUDY_DIRECTOR
References: