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

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ClinicalTrials.gov Identifier: NCT03741127
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
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 patient 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 concomitant medications, related AEs, new malignancies, new or exacerbated clinically significant neurologic, hematologic, rheumatologic or other autoimmune disorders will be recorded.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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


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 (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.

  3. 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

  4. 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

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

  6. Biomarkers for P-BCMA-101 [ Time Frame: Treatment with P-BCMA-101 through year 15 ]
    Levels of BCMA in blood and bone marrow cells

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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:


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, California
University of California, San Diego
San Diego, California, United States, 92121
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
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
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Poseida Therapeutics, Inc.
Investigators
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Study Director: Matthew A Spear, MD Poseida Therapeutics, Inc.

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Responsible Party: Poseida Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03741127     History of Changes
Other Study ID Numbers: P-BCMA-101-002
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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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