NCT03741127

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
79mo left

Started Oct 2018

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Oct 2018Nov 2032

Study Start

First participant enrolled

October 29, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2032

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2032

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

13.8 years

First QC Date

November 7, 2018

Last Update Submit

March 2, 2026

Conditions

Multiple Myeloma

Keywords

CAR-T cells

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

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

    Treatment with P-BCMA-101 through year 15

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

    Treatment with P-BCMA-101 through year 15

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

    Treatment with P-BCMA-101 through year 15

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

    Treatment with P-BCMA-101 through year 15

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

    Treatment with P-BCMA-101 through year 15

  • +6 more secondary outcomes

Study Arms (1)

P-BCMA-101 treated

OTHER

Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.

Drug: Rimiducid may be administered as indicated

Interventions

Rimiducid may be administered as indicatedDRUG

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.

Also known as: Rimiducid (safety switch activator)
P-BCMA-101 treated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of California Davis

Davis, California, 95618, United States

Location

University of California, San Diego

San Diego, California, 92121, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Wayne State - Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Maika Onishi,, M.D., P.h.D

    Sponsor Medical Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 14, 2018

Study Start

October 29, 2018

Primary Completion (Estimated)

August 1, 2032

Study Completion (Estimated)

November 1, 2032

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(13)