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Experimental cell therapy targets Hard-to-Treat myeloma

NCT ID NCT04960579

Disease control Sponsor: Poseida Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new therapy called P-BCMA-ALLO1 for people with multiple myeloma that has come back or not responded to standard treatments. The therapy uses donor immune cells that are engineered to find and attack myeloma cells. The main goals are to check safety and find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
P-BCMA-ALLO1 (a type of immune cell therapy that targets cancer cells)
What this could lead to
If successful, this could provide a new treatment option for patients with multiple myeloma that has not responded to other therapies.
What could go wrong
This is an early-phase trial, so the therapy may not work or could cause serious side effects like cytokine release syndrome. It is not yet proven to be safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 275 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Mar 2042

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must have signed written, informed consent. 2. Males or females, ≥18 years of age. 3. Must have a confirmed diagnosis of active MM. 4. Must have measurable MM. 5. Must have relapsed / refractory MM, having received treatment with a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy. 6. Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-BCMA-ALLO1 administration. 7. Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion therapy regimen (females of childbearing potential). 8. Must be at least 90 days since autologous stem cell transplant, if performed. 9. Must have adequate vital organ function within pre-determined parameters. 10. Must have recovered from toxicities due to prior therapies. 11. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Exclusion Criteria: 1. Is pregnant or lactating. 2. Has inadequate venous access. 3. Has active hemolytic anemia, plasma cell leukemia, Waldenstrom\'s macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, or amyloidosis. 4. Has an active second malignancy (not disease-free for at least 5 years) in addition to MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma. 5. Has active autoimmune disease. 6. Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc. 7. Has an active systemic infection. 8. Has a history of hepatitis B, hepatitis C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by Hepatitis C PCR on multiple occasions. 9. Is positive for cytomegalovirus (CMV) by PCR, CMV immunoglobulin M (IgM) antibody, or Coronavirus disease 2019 (COVID-19) by PCR. 10. Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia. 11. Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol. 12. Has received prior allogeneic cellular therapy or gene therapy. 13. Has received anti-cancer medications within 2 weeks of the time of initiating conditioning LD therapy. 14. Has received monoclonal antibody therapy within 4 weeks of initiating conditioning LD therapy. 15. Has received immunosuppressive medications within 2 weeks of the time of administration of P-BCMA-ALLO1, and/or expected to require them while on study. 16. Has received systemic corticosteroid therapy within 1 week or 5 half-lives (whichever is shorter) of the administration of P-BCMA-ALLO1 or is expected to require it during the course of the study. 17. Has CNS metastases or symptomatic CNS involvement of their myeloma. 18. Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study. 19. Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days. 20. Arms R, RS, RP1, RP1.5 and RP2 Only: a) Has received a live vaccine within the last 28 days of the first administration of agents used in Arm R or RS, b) Has any known hypersensitivity or severe reactions or toxicity to agents used in Arms R or RS. 21. Has received radiation within 1 week of initiating conditioning LD therapy. 22. Administration of a live vaccine within the last 28 days prior to administration of LD therapy.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Advocate Aurora Health

    Park Ridge, Illinois, 66068, United States

  • Blood Marrow and Transplant Group of Georgia

    Atlanta, Georgia, 30342, United States

  • City of Hope

    Goodyear, Arizona, 85338, United States

  • City of Hope

    Chicago, Illinois, 60099, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • Sarah Cannon Research Institute - Methodist Healthcare

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute - St. David's South Austin Medical Center

    Austin, Texas, 78704, United States

  • University of California San Diego

    San Diego, California, 92093, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-1350, United States

  • University of Oklahoma, Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4238, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wayne State - Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.