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Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03741127
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : August 6, 2020
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.

Brief Summary:
Subjects are enrolled in this study following completion or early discontinuation from a Poseida sponsored or supported study of P-BCMA-101 T cells and will be followed for a total of 15 years post treatment from the last P-BCMA-101 treatment. Subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (AEs) and assess long-term efficacy, and PK and quantification of P-BCMA-101 T cells. Rimiducid may be administered as indicated.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Rimiducid may be administered as indicated Phase 1

Detailed Description:

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (FDA, 2006; Guidance for Industry, Gene Therapy Clinical Trials-Observing Subjects for Delayed Adverse Events), long term safety and efficacy follow up of treated subjects is required. Subjects are enrolled in this study following completion or early discontinuation from a Poseida sponsored or supported study of P-BCMA-101 T cells and will be followed for a total of 15 years post treatment from the last P-BCMA-101 treatment. Subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (AEs) and assess long-term efficacy, and PK and quantification of P-BCMA-101 T cells. Rimiducid may be administered as indicated.

Study visits Subjects will only enter this protocol after completing or discontinuing from their primary P-BCMA-101 protocol.

Once enrolled in this protocol a subject will return for regular follow-up depending on when they last received P-BCMA-101 on their primary protocol:

  • Every 3 months until the end of the first year after P-BCMA-101 treatment
  • Every 6 months until the end of the third year after P-BCMA-101 treatment
  • Then yearly until the end of the 15th year after P-BCMA-101 treatment (ie. if a subject discontinues from their primary protocol 2 years after receiving P-BCMA-101, they will be entering this study at the beginning of the 3rd year, and will remain on this study for 13 years).

Subjects will undergo serial assessment of safety, chemistry, hematology, and disease response as specified in the Schedule of Events. Subjects will further undergo a physical exam and medical history, and anti-myeloma medications, related AEs, new malignancies, new or exacerbated clinically significant neurologic, hematologic, rheumatologic or other autoimmune disorders will be recorded. After progressive disease (PD) has been confirmed for a subject after P-BCMA-101 administration, visits may be performed remotely (AEs collected by telephone and laboratory studies completed at a local facility).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : August 2032
Estimated Study Completion Date : November 2032

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
P-BCMA-101 treated
Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.
Drug: Rimiducid may be administered as indicated
Patients who received P-BCMA-101 in a previous trial will be evaluated in this trial for long term safety and efficacy. Rimiducid (safety switch activator) may be administered as indicated.
Other Name: Rimiducid (safety switch activator)




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    Incidence and severity of treatment-emergent adverse events to evaluate the long-term safety of P-BCMA-101


Secondary Outcome Measures :
  1. Anti-myeloma effect of P-BCMA-101 (Response Rate) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    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

  2. Anti-myeloma effect of P-BCMA-101 (Time to Response) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    Time from P-BCMA-101 administration to time of first documented response (PR or better) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.

  3. Anti-myeloma effect of P-BCMA-101 (Duration of Response) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    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.

  4. Anti-myeloma effect of P-BCMA-101 (Progression Free Survival) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    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

  5. Anti-myeloma effect of P-BCMA-101 (Overall Survival) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    Duration of survival from time of treatment with P-BCMA-101

  6. Concentration of P-BCMA-101 cells [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    Concentration of P-BCMA-101 cells in blood and bone marrow over time

  7. Biomarkers for P-BCMA-101 (BCMA Cells) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    The persistence of anti-tumor effect of P-BCMA-101 and its relationship to persistence of P-BCMA-101 cells, BCMA tumor surface expression and circulating BCMA.

  8. Biomarkers for P-BCMA-101 (Cell Count) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    Absolute B and T lymphocyte count

  9. Biomarkers for P-BCMA-101 (Expansion) [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    Expansion and/or persistence of P-BCMA-101 T cells

  10. Incidence of adverse events related to rimiducid, if indicated [ Time Frame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable ]
    Incidence of adverse events related to rimiducid, if indicated

  11. Effect of rimiducid on grade of P-BCMA-101-related adverse events [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Subjects who have received P-BCMA-101 and completed or discontinued early from a Poseida sponsored treatment protocol.
  • Subject has provided informed consent.

Exclusion Criteria:

  • None

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): NCT03741127


Locations
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United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
United States, California
University of California Davis
Davis, California, United States, 95618
University of California, San Diego
San Diego, California, United States, 92121
University of California San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Michigan
Wayne State - Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Jersey
John Theuer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Poseida Therapeutics, Inc.
California Institute for Regenerative Medicine (CIRM)
Investigators
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Study Director: Matthew Spear, MD Sponsor Chief Medical Officer
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Responsible Party: Poseida Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03741127    
Other Study ID Numbers: P-BCMA-101-002
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poseida Therapeutics, Inc.:
CAR-T cells
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