Summary

for males ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Official Title

Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101

Details

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.

Keywords

Multiple Myeloma CAR-T cells Rimiducid may be administered as indicated

Eligibility

You can join if…

Open to males ages 18 years and up

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

You CAN'T join if...

Locations

  • University of California, San Diego
    San Diego California 92121 United States
  • Colorado Blood Cancer Institute
    Denver Colorado 80218 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Poseida Therapeutics, Inc.
ID
NCT03741127
Phase
Phase 1
Study Type
Interventional
Last Updated