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Multiple MyelomaPhase 1NCT03741127

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

A Phase 1 study testing Rimiducid may be administered as indicated in people with Multiple Myeloma, run by Poseida Therapeutics, Inc. at 13 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Rimiducid may be administered as indicated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
13 sitesUnited States
Study dates
29 Oct 2018to Nov 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • University of Chicago

    Chicago, Illinois, 60637

  • University of California Davis

    Davis, California, 95618

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Wayne State - Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of California, San Diego

    San Diego, California, 92121

  • University of California San Francisco

    San Francisco, California, 94143

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Rimiducid may be administered as indicated
Keywords
CAR-T cells
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rimiducid may be administered as indicatedDrug

    Also called Rimiducid (safety switch activator)

    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.

Study groups in NCT03741127
Study groupRoleWhat they receive
P-BCMA-101 treatedOtherPatients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.
Receives: Drug: Rimiducid may be administered as indicated

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Treatment with P-BCMA-101 through year 15

Secondary outcomes (11)

  1. 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

    Measured: Treatment with P-BCMA-101 through year 15

  2. 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.

    Measured: Treatment with P-BCMA-101 through year 15

  3. 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.

    Measured: Treatment with P-BCMA-101 through year 15

  4. 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

    Measured: Treatment with P-BCMA-101 through year 15

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

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

    Measured: Treatment with P-BCMA-101 through year 15

  6. Concentration of P-BCMA-101 cells

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

    Measured: Treatment with P-BCMA-101 through year 15

  7. 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.

    Measured: Treatment with P-BCMA-101 through year 15

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

    Absolute B and T lymphocyte count

    Measured: Treatment with P-BCMA-101 through year 15

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

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

    Measured: Treatment with P-BCMA-101 through year 15

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

    Incidence of adverse events related to rimiducid, if indicated

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

  11. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start29 Oct 2018
  3. Primary completionAug 2032 (estimated)
  4. Study completionNov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03741127
Sponsor's protocol ID
P-BCMA-101-002
Status last verified
Mar 2026
First submitted
7 Nov 2018
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rimiducid may be administered as indicated in people with Multiple Myeloma, run by Poseida Therapeutics, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Treatment with P-BCMA-101 through year 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03741127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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