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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)

Phase
Phase 1
Sponsor
Poseida Therapeutics, Inc.
Enrollment
275
Timeline
May 2022 → Mar 2042
About This Study

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).

Eligibility Criteria

Inclusion Criteria

  • 1Must have signed written, informed consent.
  • 2Males or females, ≥18 years of age.
  • 3Must have a confirmed diagnosis of active MM.
  • 4Must have measurable MM.
  • 5Must have relapsed / refractory MM, having received treatment with a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
  • 6Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-BCMA-ALLO1 administration.
  • 7Must 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).
  • 8Must be at least 90 days since autologous stem cell transplant, if performed.
  • 9Must have adequate vital organ function within pre-determined parameters.
  • 10Must have recovered from toxicities due to prior therapies.
  • 11Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion Criteria

  • 1Is pregnant or lactating.
  • 2Has inadequate venous access.
  • 3Has active hemolytic anemia, plasma cell leukemia, Waldenstrom\'s macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, or amyloidosis.
  • 4Has 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.
  • 5Has active autoimmune disease.
  • 6Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc.
  • 7Has an active systemic infection.
  • 8Has 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.
  • 9Is positive for cytomegalovirus (CMV) by PCR, CMV immunoglobulin M (IgM) antibody, or Coronavirus disease 2019 (COVID-19) by PCR.
  • 10Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia.
  • 11Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol.
  • 12Has received prior allogeneic cellular therapy or gene therapy.
  • 13Has received anti-cancer medications within 2 weeks of the time of initiating conditioning LD therapy.
  • 14Has received monoclonal antibody therapy within 4 weeks of initiating conditioning LD therapy.
  • 15Has received immunosuppressive medications within 2 weeks of the time of administration of P-BCMA-ALLO1, and/or expected to require them while on study.
  • 16Has 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.
  • 17Has CNS metastases or symptomatic CNS involvement of their myeloma.
  • 18Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
  • 19Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days.
  • 20Arms 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.
  • 21Has received radiation within 1 week of initiating conditioning LD therapy.
  • 22Administration of a live vaccine within the last 28 days prior to administration of LD therapy.

Locations

21 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

City of Hope

Goodyear, Arizona 85338

Recruiting

University of California San Diego

San Diego, California 92093

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →