Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101

Multiple Myeloma Clinical Trial

Official title:

Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03741127
• Other study ID #: P-BCMA-101-002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 29, 2018
• Est. completion date: November 2032

Study information

• Verified date: February 2024
• Source: Poseida Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 2032
• Est. primary completion date: August 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Drug:
• Rimiducid may be administered as indicated
Patients who received P-BCMA-101 in a previous trial will be evaluated in this trial for long term safety and efficacy. Rimiducid (safety switch activator) may be administered as indicated.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	University of Chicago	Chicago	Illinois
United States	University of California Davis	Davis	California
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Wayne State - Karmanos Cancer Institute	Detroit	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute at Tennessee Oncology	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California, San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	University of Kansas Cancer Center	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Poseida Therapeutics, Inc.	California Institute for Regenerative Medicine (CIRM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence and severity of treatment-emergent adverse events to evaluate the long-term safety of P-BCMA-101	Treatment with P-BCMA-101 through year 15
Secondary	Anti-myeloma effect of P-BCMA-101 (Response Rate)	Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma	Treatment with P-BCMA-101 through year 15
Secondary	Anti-myeloma effect of P-BCMA-101 (Time to Response)	Time from P-BCMA-101 administration to time of first documented response (PR or better) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.	Treatment with P-BCMA-101 through year 15
Secondary	Anti-myeloma effect of P-BCMA-101 (Duration of Response)	Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.	Treatment with P-BCMA-101 through year 15
Secondary	Anti-myeloma effect of P-BCMA-101 (Progression Free Survival)	Time from P-BCMA-101 treatment to progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, or death	Treatment with P-BCMA-101 through year 15
Secondary	Anti-myeloma effect of P-BCMA-101 (Overall Survival)	Duration of survival from time of treatment with P-BCMA-101	Treatment with P-BCMA-101 through year 15
Secondary	Concentration of P-BCMA-101 cells	Concentration of P-BCMA-101 cells in blood and bone marrow over time	Treatment with P-BCMA-101 through year 15
Secondary	Biomarkers for P-BCMA-101 (BCMA Cells)	The persistence of anti-tumor effect of P-BCMA-101 and its relationship to persistence of P-BCMA-101 cells, BCMA tumor surface expression and circulating BCMA.	Treatment with P-BCMA-101 through year 15
Secondary	Biomarkers for P-BCMA-101 (Cell Count)	Absolute B and T lymphocyte count	Treatment with P-BCMA-101 through year 15
Secondary	Biomarkers for P-BCMA-101 (Expansion)	Expansion and/or persistence of P-BCMA-101 T cells	Treatment with P-BCMA-101 through year 15
Secondary	Incidence of adverse events related to rimiducid, if indicated	Incidence of adverse events related to rimiducid, if indicated	Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable
Secondary	Effect of rimiducid on grade of P-BCMA-101-related adverse events	Effect of rimiducid on grade of P-BCMA-101-related adverse events as assessed by CTCAE v4.03, if indicated.	Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable