What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, especially CAR T cell therapies like TriPRIL CAR T Cells, often result in side effects such as cytokine release syndrome (CRS), which can cause fever, fatigue, and multiorgan dysfunction including acute kidney injury. Other frequent side effects include infections, cytopenias (low blood cell counts), and neurotoxicity. Chemotherapy agents used in lymphodepletion, such as fludarabine and cyclophosphamide, can lead to additional side effects like immunosuppression, increased infection risk, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including chimeric antigen receptor (CAR) T-cell therapies. Notably, idecabtagene vicleucel and ciltacabtagene autoleucel are CAR T-cell therapies targeting the B-cell maturation antigen (BCMA) on myeloma cells. These therapies have shown significant efficacy in relapsed or refractory Multiple Myeloma. Additionally, other drugs such as bortezomib, lenalidomide, and dexamethasone are commonly used in various combinations for treating Multiple Myeloma. These treatments aim to target and kill myeloma cells, similar to the investigational TriPRIL CAR T Cells.

What other types of research exist?

Promising novel alternatives to TriPRIL CAR T Cells for multiple myeloma patients include: 1) Selinexor, bortezomib, and dexamethasone combination therapy, which has shown positive outcomes in previously treated multiple myeloma. 2) Carfilzomib and dexamethasone, which have demonstrated efficacy in relapsed or refractory multiple myeloma. 3) Bortezomib retreatment, which has been effective in patients with relapsed multiple myeloma. These therapies have been evaluated in recent clinical trials and offer potential options for patients considering treatment in 2024.

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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

Must not have

Autologous stem cell transplantation within 3 months prior to leukapheresis

Active central nervous system (CNS) involvement by malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 6 months, 12 months, and 24 after car t cell treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing TriPRIL CAR T Cells, a new treatment that uses a patient's own immune cells to fight multiple myeloma that has come back or not responded to other treatments. The treatment involves modifying the patient's T cells to better attack cancer cells. About 18 people will participate, receiving one infusion and being monitored for an extended period. This type of therapy has shown promising results in treating various cancers, including multiple myeloma.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant using my own cells within the last 3 months.

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My cancer has spread to my brain or spinal cord.

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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

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I am currently being treated for a serious infection.

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I have had brain or spinal cord problems.

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I am not pregnant, breastfeeding, and if able to bear children, I am using effective birth control.

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I have or had plasma cell leukemia.

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I have had a stem cell transplant from a donor.

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I have serious lung problems.

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I am on immunosuppressive therapy for an autoimmune disease.

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I have symptoms of heart failure.

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I haven't had a heart attack or severe heart issues in the last 6 months.

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I have another cancer besides myeloma that was treated or not in full remission in the last 3 years.

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I cannot take certain doses of fludarabine or cyclophosphamide due to health reasons.

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I am currently positive for hepatitis B or C, or HIV.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 6 months, 12 months, and 24 after car t cell treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Dose Limiting Toxicity (DLT)

Incidence of adverse events (AEs)

Secondary study objectives

Overall Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include CAR T-cell therapy, proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. CAR T-cell therapy, such as the TriPRIL CAR T Cells, involves genetically engineering T cells to target and kill myeloma cells, leveraging the body's immune system for a personalized treatment approach. Proteasome inhibitors, like bortezomib, disrupt protein degradation in cancer cells, leading to cell death. Immunomodulatory drugs, such as lenalidomide, enhance the immune response against myeloma cells and inhibit their growth. Monoclonal antibodies, like daratumumab, target specific proteins on myeloma cells, marking them for destruction by the immune system. These treatments are crucial for Multiple Myeloma patients as they offer targeted, effective strategies to manage and potentially overcome the disease.