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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: 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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95618
      • University of California Davis
    • San Diego, California, United States, 92121
      • University of California, San Diego
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Comprehensive Cancer Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State - Karmanos Cancer Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute at Tennessee Oncology
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: P-BCMA-101 treated; Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.	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.; Other Names: Rimiducid (safety switch activator)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Biomarkers for P-BCMA-101 (Cell Count)	Absolute B and T lymphocyte count	Treatment with P-BCMA-101 through year 15
Biomarkers for P-BCMA-101 (Expansion)	Expansion and/or persistence of P-BCMA-101 T cells	Treatment with P-BCMA-101 through year 15
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
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

Collaborators and Investigators

• Sponsor: Poseida Therapeutics, Inc.
• Collaborators: California Institute for Regenerative Medicine (CIRM)
• Investigators: Study Director: Maika Onishi,, M.D., P.h.D, Sponsor Medical Director

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: CAR-T cells
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: P-BCMA-101-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No