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P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)

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ClinicalTrials.gov Identifier: NCT03288493
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2017
First Posted Date  ICMJE September 20, 2017
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE September 20, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
Maximum tolerated dose of P-BCMA-101 based on dose limiting toxicities [ Time Frame: Baseline through Day 28 ]
Rate of dose limiting toxicities
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
Safety and maximum tolerated dose of P-BCMA-101 based on dose limiting toxicities [ Time Frame: Baseline through Day 28 ]
Rate of dose limiting toxicities
Change History Complete list of historical versions of study NCT03288493 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Baseline through Month 24 ]
    Incidence and severity of treatment-emergent adverse events
  • Anti-myeloma effect of P-BCMA-101(Response Rate) [ Time Frame: Baseline through Month 24 ]
    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.
  • Anti-myeloma effect of P-BCMA-101(Duration of Response) [ Time Frame: Baseline through Month 24 ]
    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.
  • Anti-myeloma effect of P-BCMA-101(Progression Free Survival) [ Time Frame: Baseline through Month 24 ]
    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
  • Anti-myeloma effect of P-BCMA-101(Overall Survival) [ Time Frame: Baseline through Month 24 ]
    Duration of survival from time of treatment with P-BCMA-101
  • Pharmacokinetics of P-BCMA-101 [ Time Frame: Baseline through Month 24 ]
    Concentration of P-BCMA-101 cells in blood and bone marrow over time
  • Biomarkers for P-BCMA-101 [ Time Frame: Baseline through Month 24 ]
    Levels of BCMA in blood and bone marrow cells
  • Safety of rimiducid [ Time Frame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable ]
    Incidence of adverse events related to rimiducid, if indicated
  • Effect of rimiducid [ Time Frame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable ]
    Effect of rimiducid on grade of P-BCMA-101-related adverse events as assessed by CTCAE v4.03, if indicated
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Baseline through Month 24 ]
    Incidence and severity of treatment-emergent adverse events
  • Anti-myeloma effect of P-BCMA-101(Response Rate) [ Time Frame: Baseline through Month 24 ]
    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.
  • Anti-myeloma effect of P-BCMA-101(Duration of Response) [ Time Frame: Baseline through Month 24 ]
    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.
  • Anti-myeloma effect of P-BCMA-101(Progression Free Survival) [ Time Frame: Baseline through Month 24 ]
    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
  • Anti-myeloma effect of P-BCMA-101(Overall Survival) [ Time Frame: Baseline through Month 24 ]
    Duration of survival from time of treatment with P-BCMA-101
  • Pharmacokinetics of P-BCMA-101 [ Time Frame: Baseline through Month 24 ]
    Concentration of P-BCMA-101 cells in blood and bone marrow over time
  • Biomarkers for P-BCMA-101 [ Time Frame: Baseline through Month 24 ]
    Levels of BCMA in blood and bone marrow cells
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Official Title  ICMJE Open-Label, Multicenter, Single Ascending Dose Study to Assess the Safety of P-BCMA-101 in Subjects With Relapsed and/or Refractory Multiple Myeloma (MM)
Brief Summary This is a Phase 1, open-label, multi-center study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed and/or refractory MM. Rimiducid may be administered as indicated.
Detailed Description The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
3 + 3 design of dose-escalating cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Biological: P-BCMA-101 CAR-T cells
    P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a "safety switch" gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.
  • Drug: Rimiducid
    Rimiducid (safety switch activator) may be administered as indicated.
Study Arms Experimental: P-BCMA-101 CAR-T cells
Single dose, intravenous infusion, CAR-T cells. Rimiducid may be administered as indicated.
Interventions:
  • Biological: P-BCMA-101 CAR-T cells
  • Drug: Rimiducid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females, ≥18 years of age
  • Must have a confirmed diagnosis of active MM
  • Must have measurable MM
  • Must have relapsed and/or refractory MM, having received treatment with proteasome inhibitor and IMiD
  • Must have adequate hepatic, renal, cardiac and hematopoietic function

Exclusion Criteria:

  • Is pregnant or lactating
  • Has inadequate venous access and/or contraindications to leukapheresis
  • Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, amyloidosis, significant autoimmune, CNS or other malignant disease
  • Has an active systemic infection
  • Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol
  • Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry
  • Has CNS metastases or symptomatic CNS involvement
  • Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Michelle Resler 1-858-779-3100 mresler@poseida.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03288493
Other Study ID Numbers  ICMJE P-BCMA-101-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Poseida Therapeutics, Inc.
Study Sponsor  ICMJE Poseida Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Matthew A Spear, M.D. Sponsor Chief Medical Officer
PRS Account Poseida Therapeutics, Inc.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP