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CAR T-cell Therapy
CAR-T Cell Therapy for Multiple Myeloma (MM Trial)
Phase 1
Recruiting
Research Sponsored by Poseida Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Must be at least 90 days since autologous stem cell transplant, if performed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 15 years
Awards & highlights
MM Trial Summary
This trial is testing a new treatment for multiple myeloma that uses CAR-T cells.
Who is the study for?
Adults with active Multiple Myeloma who've had prior treatments including proteasome inhibitors, IMiDs, and anti-CD38 therapy. They must have measurable disease that's relapsed/refractory, be willing to use birth control, and have good organ function. Excluded are pregnant individuals, those with certain viral infections or a history of severe allergies to trial drugs.Check my eligibility
What is being tested?
The study is testing P-BCMA-ALLO1 CAR-T cells alongside Rimiducid in adults with Multiple Myeloma that has not responded to standard treatments. It's an early-phase trial where researchers will test different doses to find the safest and most effective one.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related symptoms like fever or chills, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Specific side effects related to CAR-T therapies can vary from person to person.
MM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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It has been over 90 days since my stem cell transplant.
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My vital organs are functioning well.
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I have been diagnosed with active multiple myeloma.
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My multiple myeloma has returned or didn't respond after treatment with specific drugs.
MM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)
Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells.
Phase 1b: The effect of cell dose and study arm to guide selection of Recommended Phase 2 Dose (RP2D).
Secondary outcome measures
The anti-Myeloma effect of P-BCMA-ALLO1 (DOR)
The anti-Myeloma effect of P-BCMA-ALLO1 (OS)
The anti-Myeloma effect of P-BCMA-ALLO1 (PFS)
+3 moreMM Trial Design
17Treatment groups
Experimental Treatment
Group I: P-BCMA-ALLO1 CAR-T cells (Arm480)Experimental Treatment2 Interventions
Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2.
Rimiducid may be administered as indicated.
Group II: P-BCMA-ALLO1 CAR-T cells (Arm160)Experimental Treatment2 Interventions
Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2.
Rimiducid may be administered as indicated.
Group III: P-BCMA-ALLO1 CAR-T cells (Arm S)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S.
Rimiducid may be administered as indicated.
Group IV: P-BCMA-ALLO1 CAR-T cells (Arm RS)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RS.
Rimiducid may be administered as indicated.
Group V: P-BCMA-ALLO1 CAR-T cells (Arm RP2)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP2.
Rimiducid may be administered as indicated.
Group VI: P-BCMA-ALLO1 CAR-T cells (Arm RP1.5)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.5.
Rimiducid may be administered as indicated.
Group VII: P-BCMA-ALLO1 CAR-T cells (Arm RP1)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.
Rimiducid may be administered as indicated.
Group VIII: P-BCMA-ALLO1 CAR-T cells (Arm R)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen R.
Rimiducid may be administered as indicated.
Group IX: P-BCMA-ALLO1 CAR-T cells (Arm P2)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P2.
Rimiducid may be administered as indicated.
Group X: P-BCMA-ALLO1 CAR-T cells (Arm P1.5)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.5.
Rimiducid may be administered as indicated.
Group XI: P-BCMA-ALLO1 CAR-T cells (Arm P1)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.
Rimiducid may be administered as indicated.
Group XII: P-BCMA-ALLO1 CAR-T cells (Arm N)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated.
Group XIII: P-BCMA-ALLO1 CAR-T cells (Arm F)Experimental Treatment2 Interventions
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen F.
Rimiducid may be administered as indicated.
Group XIV: P-BCMA-ALLO1 CAR-T cells (Arm CP2)Experimental Treatment2 Interventions
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP2.
Rimiducid may be administered as indicated.
Group XV: P-BCMA-ALLO1 CAR-T cells (Arm CP1.5)Experimental Treatment2 Interventions
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.5.
Rimiducid may be administered as indicated.
Group XVI: P-BCMA-ALLO1 CAR-T cells (Arm CP1)Experimental Treatment2 Interventions
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.
Rimiducid may be administered as indicated.
Group XVII: P-BCMA-ALLO1 CAR-T cells (Arm C)Experimental Treatment2 Interventions
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen C.
Rimiducid may be administered as indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimiducid
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Poseida Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
465 Total Patients Enrolled
2 Trials studying Multiple Myeloma
205 Patients Enrolled for Multiple Myeloma
Roche-GenentechIndustry Sponsor
24 Previous Clinical Trials
3,454 Total Patients Enrolled
1 Trials studying Multiple Myeloma
265 Patients Enrolled for Multiple Myeloma
Matthew Spear, M.D.Study DirectorSponsor Chief Medical Officer
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received monoclonal antibody therapy less than 4 weeks ago.My cancer has spread to my brain or spinal cord.You have a current autoimmune disease.I am currently fighting an infection in my body.I have a history of serious brain or nerve conditions like stroke or epilepsy.I have taken or might need immunosuppressive drugs recently or while in the study.I have recovered from side effects of previous treatments.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of hepatitis B, C, HIV, HTLV, or any immunodeficiency but meet specific treatment criteria.I have another cancer besides MM, not in remission for 5 years, except for certain skin cancers.Women who could become pregnant must have a negative pregnancy test before starting the treatment.It has been over 90 days since my stem cell transplant.I have severe heart issues, including heart failure or a recent heart attack.My vital organs are functioning well.I have not taken systemic steroids recently and don't expect to need them during the study.I have had a stem cell transplant or any other organ transplant from a donor, or my own cells within the last 3 months.I have been diagnosed with active multiple myeloma.You do not have suitable veins for receiving medication through an IV.The disease must be able to be measured in a specific way.I have taken cancer medication within the last 2 weeks.My multiple myeloma has returned or didn't respond after treatment with specific drugs.I have had a treatment involving cells or genes from a donor.You have had a serious allergic reaction to any of the drugs used in this study in the past.I am 18 years old or older.I have a specific blood disorder such as hemolytic anemia or Waldenstrom's macroglobulinemia.I haven't had a live vaccine in the last 28 days and don't have severe allergies to treatments in Arms R or RS.
Research Study Groups:
This trial has the following groups:- Group 1: P-BCMA-ALLO1 CAR-T cells (Arm P1.5)
- Group 2: P-BCMA-ALLO1 CAR-T cells (Arm RP1)
- Group 3: P-BCMA-ALLO1 CAR-T cells (Arm RP1.5)
- Group 4: P-BCMA-ALLO1 CAR-T cells (Arm CP1)
- Group 5: P-BCMA-ALLO1 CAR-T cells (Arm RP2)
- Group 6: P-BCMA-ALLO1 CAR-T cells (Arm CP1.5)
- Group 7: P-BCMA-ALLO1 CAR-T cells (Arm CP2)
- Group 8: P-BCMA-ALLO1 CAR-T cells (Arm R)
- Group 9: P-BCMA-ALLO1 CAR-T cells (Arm RS)
- Group 10: P-BCMA-ALLO1 CAR-T cells (Arm C)
- Group 11: P-BCMA-ALLO1 CAR-T cells (Arm160)
- Group 12: P-BCMA-ALLO1 CAR-T cells (Arm480)
- Group 13: P-BCMA-ALLO1 CAR-T cells (Arm S)
- Group 14: P-BCMA-ALLO1 CAR-T cells (Arm F)
- Group 15: P-BCMA-ALLO1 CAR-T cells (Arm N)
- Group 16: P-BCMA-ALLO1 CAR-T cells (Arm P1)
- Group 17: P-BCMA-ALLO1 CAR-T cells (Arm P2)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any past experiments that demonstrate the efficacy of P-BCMA-ALLO1 CAR-T cells?
"At the time of writing, there exist 16 studies pertaining to P-BCMA-ALLO1 CAR-T cells with no trials occurring in Phase 3. While most are based out of San Diego, California, 94 other sites across America have initiated clinical trials concerning this topic."
Answered by AI
Has the FDA sanctioned P-BCMA-ALLO1 CAR-T cells for commercial use?
"P-BCMA-ALLO1 CAR-T cells have limited clinical data supporting both their safety and efficacy, so Power assigned it a score of 1."
Answered by AI
Is there still availability to join this trial?
"According to the clinicaltrials.gov portal, this research study is presently enrolling participants. It was initially shared on May 5th 2022 and most recently amended on September 23rd 2022."
Answered by AI
How many US venues are currently undertaking this experiment?
"At present, there are 8 clinical trial sites where this medical study is enrolling patients. For example, the University of Oklahoma Health Sciences Center in Oklahoma City, Advocate Aurora Health in Park Ridge and the University of California San Francisco in San Francisco all have participant programs available."
Answered by AI
How many participants are currently included in this medical research?
"In order to complete this clinical trial, 40 suitable patients must be recruited. The sponsor of the study, Poseida Therapeutics, Inc., have selected two sites - University of Oklahoma Health Sciences Center in Oklahoma City and University of California San Francisco in San Francisco - from which they will operate."
Answered by AI
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