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CAR T-cell Therapy
TriPRIL CAR T Cell Therapy for Multiple Myeloma
Phase 1
Recruiting
Led By Matthew J Frigault, MD
Research Sponsored by Marcela V. Maus, M.D.,Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at the time of signing informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 months, 12 months, and 24 after car t cell treatment.
Awards & highlights
Study Summary
This trial will study the safety and anti-tumor activity of TriPRIL CAR T cells in participants with relapsed or refractory multiple myeloma who have received at least 2 prior therapies.
Who is the study for?
This trial is for adults over 18 with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including specific inhibitors and antibodies. They must be in relatively good health (ECOG 0-2), not pregnant, willing to use birth control, and able to consent. People with certain heart conditions, active infections, recent other cancer treatments or stem cell transplants can't join.Check my eligibility
What is being tested?
The study tests TriPRIL CAR T Cells designed to treat multiple myeloma that's come back or hasn't responded to treatment. Participants also receive Fludarabine and Cyclophosphamide chemotherapy drugs as part of the process before getting the new therapy.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever and fatigue, organ inflammation, blood count changes from chemotherapy drugs used beforehand (Fludarabine & Cyclophosphamide), and possible infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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My multiple myeloma has not responded to at least 3 treatments including specific types.
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My cell sample for treatment has been accepted by the lab.
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I agree to use effective birth control during and for 6 months after the study.
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My multiple myeloma has returned or didn't respond to treatment, and it can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month, 6 months, 12 months, and 24 after car t cell treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 6 months, 12 months, and 24 after car t cell treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Dose Limiting Toxicity (DLT)
Incidence of adverse events (AEs)
Secondary outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: TriPRIL CAR T Cells-Dose ExpansionExperimental Treatment3 Interventions
Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes:
Leukapheresis: On day -8 white blood cells will be collected.
Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes
TriPRIL CAR T Cells will be administered intravenously on day 0 using the respective dose (at or below the Maximum Tolerated Dose-MTD), as determined during the dose escalation part.
Group II: TriPRIL CAR T Cells-Dose EscalationExperimental Treatment3 Interventions
Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes:
Leukapheresis: On day -8 white blood cells will be collected.
Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes
TriPRIL CAR T Cells will be administered intravenously on day 0 using a 3+3 dose escalation design
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Marcela V. Maus, M.D.,Ph.D.Lead Sponsor
4 Previous Clinical Trials
66 Total Patients Enrolled
Matthew J Frigault, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from previous cancer treatment side effects, except for hair loss or mild nerve issues.I had a stem cell transplant using my own cells within the last 3 months.I am 18 years old or older.I am able to care for myself and perform daily activities.My organs and bone marrow are working well.My cell sample for treatment has been accepted by the lab.My cancer has spread to my brain or spinal cord.I have another cancer, but it won't affect this trial's treatment.My multiple myeloma has not responded to at least 3 treatments including specific types.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am currently being treated for a serious infection.I agree to use effective birth control during and for 6 months after the study.My multiple myeloma has returned or didn't respond to treatment, and it can be measured.I am not on any medications that could affect the study.I have had brain or spinal cord problems.I haven't had treatments for my multiple myeloma in the last 14 days.I am not pregnant, breastfeeding, and if able to bear children, I am using effective birth control.I have or had plasma cell leukemia.I have had a stem cell transplant from a donor.You have had allergic reactions to similar chemicals or biological substances as the CAR-T cells.I have serious lung problems.I am on immunosuppressive therapy for an autoimmune disease.I haven't had CAR-T cell therapy in the last 6 months.I have symptoms of heart failure.I haven't had a heart attack or severe heart issues in the last 6 months.I have another cancer besides myeloma that was treated or not in full remission in the last 3 years.You are expected to live for at least 12 more weeks.I cannot take certain doses of fludarabine or cyclophosphamide due to health reasons.I haven't had a blood clot in my lungs or legs in the last 3 months.I am currently positive for hepatitis B or C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: TriPRIL CAR T Cells-Dose Escalation
- Group 2: TriPRIL CAR T Cells-Dose Expansion
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.
Has the FDA issued a clearance for TriPRIL CAR T Cells yet?
"Due to the preliminary nature of this clinical trial, our team has assigned TriPRIL CAR T Cells a safety score of 1. This indicates that there is only limited evidence supporting its efficacy and safety at this point in time."
Answered by AI
What conditions has TriPRIL CAR T Cells been employed to treat?
"TriPRIL CAR T Cells is generally used to manage the symptoms of multiple sclerosis. But it can also be employed to combat various other ailments such as leukemia, lymphoma, myelocytic and retinoblastoma afflictions."
Answered by AI
Are participants currently being registered for this investigation?
"According to the details on clinicaltrials.gov, this study is actively recruiting participants since October 5th 2021. The initial post was updated just a few weeks ago on October 28th 2021."
Answered by AI
What other experiments have been done to evaluate the efficacy of TriPRIL CAR T Cells?
"At the present moment, 889 clinical trials are underway exploring TriPRIL CAR T Cells. Of these studies, 161 have reached phase 3 testing. Most of them are based in Philadelphia, Pennsylvania but there exist 28443 globally-dispersed locations conducting research on this therapy."
Answered by AI
What is the uppermost limit of participants for this trial?
"Yes, there is proof on clinicaltrials.gov that this research trial has begun searching for participants. It was initially posted on October 5th 2021 and the most recent update happened October 28th 2021. They require 18 individuals from a single medical centre to take part in this study."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
What portion of applicants met pre-screening criteria?
Met criteria
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