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NCT Number: NCT03741127

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California Davis, Davis, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rimiducid may be administered as indicated

Drug

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)

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Treatment with P-BCMA-101 through year 15

    Incidence and severity of treatment-emergent adverse events to evaluate the long-term safety of P-BCMA-101

Secondary outcomes

  1. Anti-myeloma effect of P-BCMA-101 (Response Rate)

    Time frame: Treatment with P-BCMA-101 through year 15

    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

  2. Anti-myeloma effect of P-BCMA-101 (Time to Response)

    Time frame: Treatment with P-BCMA-101 through year 15

    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.

  3. Anti-myeloma effect of P-BCMA-101 (Duration of Response)

    Time frame: Treatment with P-BCMA-101 through year 15

    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.

  4. Anti-myeloma effect of P-BCMA-101 (Progression Free Survival)

    Time frame: Treatment with P-BCMA-101 through year 15

    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

  5. Anti-myeloma effect of P-BCMA-101 (Overall Survival)

    Time frame: Treatment with P-BCMA-101 through year 15

    Duration of survival from time of treatment with P-BCMA-101

  6. Concentration of P-BCMA-101 cells

    Time frame: Treatment with P-BCMA-101 through year 15

    Concentration of P-BCMA-101 cells in blood and bone marrow over time

  7. Biomarkers for P-BCMA-101 (BCMA Cells)

    Time frame: Treatment with P-BCMA-101 through year 15

    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.

  8. Biomarkers for P-BCMA-101 (Cell Count)

    Time frame: Treatment with P-BCMA-101 through year 15

    Absolute B and T lymphocyte count

  9. Biomarkers for P-BCMA-101 (Expansion)

    Time frame: Treatment with P-BCMA-101 through year 15

    Expansion and/or persistence of P-BCMA-101 T cells

  10. Incidence of adverse events related to rimiducid, if indicated

    Time frame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable

    Incidence of adverse events related to rimiducid, if indicated

  11. Effect of rimiducid on grade of P-BCMA-101-related adverse events

    Time frame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable

    Effect of rimiducid on grade of P-BCMA-101-related adverse events as assessed by CTCAE v4.03, if indicated.

Sponsors and collaborators

Lead sponsor

Poseida Therapeutics, Inc.

Industry

Collaborators

  • California Institute for Regenerative Medicine (CIRM)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2032
Study completion
2032
First posted
Nov 14, 2018
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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