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CAR T-cell Therapy
Long-Term Follow-Up of P-BCMA-101 for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Poseida Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rimiducid infusion through year 15 after p-bcma-101 infusion, if applicable
Awards & highlights
No Placebo-Only Group
Summary
This trial will follow subjects for 15 years to assess long-term safety and effectiveness of P-BCMA-101 T cells. Rimiducid may be given as needed.
Who is the study for?
This trial is for individuals who have previously received P-BCMA-101 T cell treatment for multiple myeloma, either completing or discontinuing early from a Poseida sponsored study. Participants must consent to long-term follow-up.
What is being tested?
The study monitors the safety and effectiveness of P-BCMA-101 T cells over 15 years post-treatment. It evaluates the risk of delayed side effects, ongoing benefits, and tracks levels of these specialized T cells in subjects.
What are the potential side effects?
While specific side effects are not listed, this trial will assess any delayed adverse events related to P-BCMA-101 T cell therapy that may occur over the long term.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ rimiducid infusion through year 15 after p-bcma-101 infusion, if applicable
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~rimiducid infusion through year 15 after p-bcma-101 infusion, if applicable
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Anti-myeloma effect of P-BCMA-101 (Duration of Response)
Anti-myeloma effect of P-BCMA-101 (Overall Survival)
Anti-myeloma effect of P-BCMA-101 (Progression Free Survival)
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: P-BCMA-101 treatedExperimental Treatment1 Intervention
Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.
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Who is running the clinical trial?
Poseida Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
696 Total Patients Enrolled
2 Trials studying Multiple Myeloma
336 Patients Enrolled for Multiple Myeloma
California Institute for Regenerative Medicine (CIRM)OTHER
69 Previous Clinical Trials
3,258 Total Patients Enrolled
1 Trials studying Multiple Myeloma
105 Patients Enrolled for Multiple Myeloma
Rajesh Belani, M.D.Study DirectorSponsor Executive Medical Director
4 Previous Clinical Trials
576 Total Patients Enrolled
2 Trials studying Multiple Myeloma
336 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- N/AYou have already taken P-BCMA-101 as part of another study sponsored by Poseida and either finished or stopped early.
Research Study Groups:
This trial has the following groups:- Group 1: P-BCMA-101 treated
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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