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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rimiducid may be administered as indicated
Sponsored by
Poseida Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma focused on measuring CAR-T cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis
  • University of California, San Diego
  • University of California San Francisco
  • Colorado Blood Cancer Institute
  • University of Chicago
  • University of Kansas Cancer Center
  • University of Maryland Greenebaum Comprehensive Cancer Center
  • Johns Hopkins University
  • Wayne State - Karmanos Cancer Institute
  • University of Pennsylvania
  • Sarah Cannon Research Institute at Tennessee Oncology
  • Vanderbilt University Medical Center
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

P-BCMA-101 treated

Arm Description

Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence and severity of treatment-emergent adverse events to evaluate the long-term safety of P-BCMA-101

Secondary Outcome Measures

Anti-myeloma effect of P-BCMA-101 (Response Rate)
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 (Time to Response)
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.
Anti-myeloma effect of P-BCMA-101 (Duration of Response)
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 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)
Duration of survival from time of treatment with P-BCMA-101
Concentration of P-BCMA-101 cells
Concentration of P-BCMA-101 cells in blood and bone marrow over time
Biomarkers for P-BCMA-101 (BCMA Cells)
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.
Biomarkers for P-BCMA-101 (Cell Count)
Absolute B and T lymphocyte count
Biomarkers for P-BCMA-101 (Expansion)
Expansion and/or persistence of P-BCMA-101 T cells
Incidence of adverse events related to rimiducid, if indicated
Incidence of adverse events related to rimiducid, if indicated
Effect of rimiducid on grade of P-BCMA-101-related adverse events
Effect of rimiducid on grade of P-BCMA-101-related adverse events as assessed by CTCAE v4.03, if indicated.

Full Information

First Posted
November 7, 2018
Last Updated
September 6, 2023
Sponsor
Poseida Therapeutics, Inc.
Collaborators
California Institute for Regenerative Medicine (CIRM)
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1. Study Identification

Unique Protocol Identification Number
NCT03741127
Brief Title
Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101
Official Title
Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
August 2032 (Anticipated)
Study Completion Date
November 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poseida Therapeutics, Inc.
Collaborators
California Institute for Regenerative Medicine (CIRM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
CAR-T cells

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P-BCMA-101 treated
Arm Type
Other
Arm Description
Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.
Intervention Type
Drug
Intervention Name(s)
Rimiducid may be administered as indicated
Other Intervention Name(s)
Rimiducid (safety switch activator)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence and severity of treatment-emergent adverse events to evaluate the long-term safety of P-BCMA-101
Time Frame
Treatment with P-BCMA-101 through year 15
Secondary Outcome Measure Information:
Title
Anti-myeloma effect of P-BCMA-101 (Response Rate)
Description
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
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Anti-myeloma effect of P-BCMA-101 (Time to Response)
Description
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.
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Anti-myeloma effect of P-BCMA-101 (Duration of Response)
Description
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.
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Anti-myeloma effect of P-BCMA-101 (Progression Free Survival)
Description
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
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Anti-myeloma effect of P-BCMA-101 (Overall Survival)
Description
Duration of survival from time of treatment with P-BCMA-101
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Concentration of P-BCMA-101 cells
Description
Concentration of P-BCMA-101 cells in blood and bone marrow over time
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Biomarkers for P-BCMA-101 (BCMA Cells)
Description
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.
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Biomarkers for P-BCMA-101 (Cell Count)
Description
Absolute B and T lymphocyte count
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Biomarkers for P-BCMA-101 (Expansion)
Description
Expansion and/or persistence of P-BCMA-101 T cells
Time Frame
Treatment with P-BCMA-101 through year 15
Title
Incidence of adverse events related to rimiducid, if indicated
Description
Incidence of adverse events related to rimiducid, if indicated
Time Frame
Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable
Title
Effect of rimiducid on grade of P-BCMA-101-related adverse events
Description
Effect of rimiducid on grade of P-BCMA-101-related adverse events as assessed by CTCAE v4.03, if indicated.
Time Frame
Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Belani, M.D.
Organizational Affiliation
Sponsor Executive Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
University of California Davis
City
Davis
State/Province
California
ZIP/Postal Code
95618
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Maryland Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Wayne State - Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon Research Institute at Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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