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P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma (MM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04960579
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.

Brief Summary:
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: P-BCMA-ALLO1 CAR-T cells Drug: Rimiducid Phase 1

Detailed Description:
Phase 1 study follows a 3+3 design of dose-escalating cohorts. After a subject enrolls, allogeneic CAR-T cells will be administered as a single dose, following a standard chemotherapy based conditioning regimen. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
Actual Study Start Date : May 5, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : March 2038

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: P-BCMA-ALLO1 CAR-T cells (single dose)
Dose escalation cohorts, administered intravenously as a single dose following a conditioning chemotherapy regimen. Rimiducid may be administered as indicated.
Biological: P-BCMA-ALLO1 CAR-T cells
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy

Drug: Rimiducid
Safety switch activator




Primary Outcome Measures :
  1. Assess the maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT) [ Time Frame: Baseline through Day 28 ]
    Rate of dose limiting toxicities (DLT)


Secondary Outcome Measures :
  1. The safety of P-BCMA-ALLO1 [ Time Frame: Baseline through 15 years ]
    Incidence and severity of treatment-emergent adverse events

  2. The anti-myeloma effect of P-BCMA-ALLO1 (ORR) [ Time Frame: Baseline through 15 years ]
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR) - Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR)

  3. The anti-myeloma effect of P-BCMA-ALLO1 (TTR) [ Time Frame: Baseline through 15 years ]
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR) - Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease

  4. The anti-Myeloma effect of P-BCMA-ALLO1 (DOR) [ Time Frame: Baseline through 15 years ]
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response - Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease

  5. The anti-Myeloma effect of P-BCMA-ALLO1 (PFS) [ Time Frame: Baseline through 15 years ]
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS) - Time from P-BCMA-ALLO1 treatment to progressive disease

  6. The anti-Myeloma effect of P-BCMA-ALLO1 (OS) [ Time Frame: Baseline through 15 years ]
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS) - Duration of survival from time of treatment with P-BCMA-ALLO1

  7. The effect of cell dose to guide selection of doses for further assessment in Phase 2/3 studies [ Time Frame: Baseline through 36 months ]
    Incidence and severity of CRS events graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria (Lee, 2019)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 chemotherapy 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.
  9. Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia.
  10. Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol.
  11. Has received prior gene therapy or gene-modified cellular immunotherapy or T cell engaging antibodies.
  12. Has received anti-cancer medications within 2 weeks of the time of initiating conditioning chemotherapy.
  13. 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.
  14. 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.
  15. Has CNS metastases or symptomatic CNS involvement of their myeloma.
  16. Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04960579


Contacts
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Contact: Angie Schinkel 858-779-3103 clinicaltrials@poseida.com

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92093
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
United States, Illinois
Advocate Aurora Health Not yet recruiting
Park Ridge, Illinois, United States, 66068
United States, Maryland
University of Maryland Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
United States, Oklahoma
University of Oklahoma, Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Sarah Cannon Research Institute - St. David's South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
Sarah Cannon Research Institute - Methodist Healthcare Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Poseida Therapeutics, Inc.
Investigators
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Study Director: Rajesh Belani, M.D. Executive Medical Director
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Responsible Party: Poseida Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04960579    
Other Study ID Numbers: P-BCMA-ALLO1-001
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases