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

NCT04960579
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
275
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Lead sponsor
Poseida Therapeutics, Inc.
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Start date
2022-05-05
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Number of sites
23
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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).
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Acronym
MM
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Short title
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
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Official title
Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2042-03-01
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First posted
2021-07-14
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Registry last updated
2026-04-24
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Primary completion date
2029-03-01
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Start date
2022-05-05
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Participants
275
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Participant count basis
Estimated
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Planned participants
275
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Protocol amendments
6
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Number of sites
23
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Poseida Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT04960579
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ClinicalTrials.gov ID
NCT04960579
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)

    Timeframe: Baseline through Day 28

    Rate of dose limiting toxicities (DLT)

  2. Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells.

    Timeframe: Baseline through 36 months

    Frequency and severity of adverse events, including cytokine release syndrome.

  3. Phase 1b: The effect of cell dose and study arm

    Timeframe: Baseline through 36 months

    Overall response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria

  1. The safety of P-BCMA-ALLO1

    Timeframe: Baseline through 15 years

    Incidence and severity of treatment-emergent adverse events

  2. The anti-myeloma effect of P-BCMA-ALLO1 (ORR) in Phase 1 Parts 1 and 2

    Timeframe: 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. Safety and Efficacy (anti-myeloma effect) will be used to guide the selection of RP2D

    Timeframe: 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, Overall response rate (ORR), Duration of response (DOR), Progression free survival (PFS), and Overall survival (OS)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
clinicaltrials.gov

  • City of HopeGoodyear, United States
  • University of California San DiegoSan Diego, United States
  • University of California San FranciscoSan Francisco, United States
  • Emory UniversityAtlanta, United States
  • Blood Marrow and Transplant Group of GeorgiaAtlanta, United States
  • City of HopeChicago, United States
  • Advocate Aurora HealthPark Ridge, United States
  • University of IowaIowa City, United States
  • University of Kansas Medical CenterKansas City, United States
  • University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, United States
  • Wayne State - Karmanos Cancer InstituteDetroit, United States
  • Hackensack Meridian HealthHackensack, United States
  • Roswell Park Comprehensive Cancer CenterBuffalo, United States
  • Mount SinaiNew York, United States
  • University of North Carolina at Chapel HillChapel Hill, United States
  • University of CincinnatiCincinnati, United States
  • Cleveland ClinicCleveland, United States
  • University of Oklahoma, Health Sciences CenterOklahoma City, United States
  • University of PennsylvaniaPhiladelphia, United States
  • Vanderbilt University Medical CenterNashville, United States
  • Sarah Cannon Research Institute - St. David's South Austin Medical CenterAustin, United States
  • Houston Methodist Research InstituteHouston, United States
  • Sarah Cannon Research Institute - Methodist HealthcareSan Antonio, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • XO44788
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)