What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including CAR-T cell therapies, bortezomib, dexamethasone, and lenalidomide, are associated with several side effects. CAR-T cell therapies can cause cytokine release syndrome, neurotoxicity, and cytopenias. Bortezomib often leads to peripheral neuropathy, gastrointestinal issues, and fatigue. Dexamethasone can cause hyperglycemia, increased risk of infections, and mood changes. Lenalidomide is associated with myelosuppression, thromboembolic events, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of Multiple Myeloma, including idecabtagene vicleucel and ciltacabtagene autoleucel, which target the B-cell maturation antigen (BCMA). Other related drugs include the anti-BCMA antibody-drug conjugate belantamab mafodotin. Additionally, bispecific T cell engagers (BiTEs) such as teclistamab have been explored. These therapies are designed to target refractory myeloma, similar to the BAFF Ligand CAR-T Cells being studied.

What other types of research exist?

Promising alternatives to BAFF Ligand CAR-T Cells for treating refractory myeloma include: 1) P-PSMA-101 CAR-T cells, which are being studied in phase 1 trials for metastatic castration-resistant prostate cancer but may have potential applications in myeloma. 2) CD19-targeted CAR-T cells, which have shown remarkable efficacy in treating relapsed/refractory acute lymphocytic leukemia and Non-Hodgkin's lymphoma, and could be adapted for myeloma. 3) Brexucabtagene autoleucel (KTE-X19), a CAR-T cell therapy directed against CD19, which has achieved durable remissions in relapsed or refractory mantle cell lymphoma and may be explored for myeloma treatment.

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CAR T-cell Therapy

CAR-T Cell Therapy for Multiple Myeloma (LMY-920-002 Trial)

Phase 1

Recruiting

Led By Leland Metheny, MD

Research Sponsored by Luminary Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cardiac ejection fraction of >45%, and no evidence of pericardial effusion, as determined by an echocardiogram.

Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.

Must not have

Known additional malignancies which require systemic treatment.

History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new type of CAR-T cell to see if it can help people with myeloma who have relapsed after previous CAR-T cell treatment.

Who is the study for?

This trial is for adults over 18 with myeloma that's come back or hasn't responded after at least three treatments, including specific drugs. They must have measurable disease, be in relatively good health (ECOG ≤ 2), and not pregnant or breastfeeding. Participants need functioning major organs and can't have had certain other cancers or heart, lung, liver problems.

What is being tested?

The study tests a new CAR-T cell therapy using BAFF-ligand on patients whose myeloma has relapsed or is refractory to treatment. It's an early-phase trial to see how well these modified immune cells work against cancer that didn’t respond to previous therapies like BCMA targeting CAR-T cells.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells, such as fever and fatigue (cytokine release syndrome), nerve damage symptoms (neurotoxicity), low blood cell counts increasing infection risk, and organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart pumps well and I don't have fluid around it.

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My oxygen level is 92% or higher without extra oxygen.

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I agree to not have sex or use birth control and not donate sperm.

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I can take care of myself but might not be able to do heavy physical work.

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My myeloma has returned or didn't respond after 3 treatments including specific drugs.

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My cancer has not spread to my brain or spinal cord.

Exclusion Criteria

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

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I have another cancer that needs treatment through the bloodstream.

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I have an autoimmune disease and needed strong medication for it within the last 6 months.

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I am experiencing complications from a transplant.

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My tests show early signs of a bone marrow disorder before starting treatment.

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I have hepatitis but my PCR test for it is negative.

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I do not have any severe illnesses that would stop me from following the study's requirements.

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I have an active cancer other than non-dangerous skin cancer or early-stage cancers.

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I have had a stem cell transplant from a donor.

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I have had a stem cell transplant within the last 6 weeks.

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I am not pregnant or breastfeeding and have a negative pregnancy test.

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I am HIV positive.

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I do not have active brain or spinal cord involvement by my cancer.

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I am currently receiving IV treatment for an infection.

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I have severe heart failure.

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I have a history of significant brain-related health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine recommended phase II dose of human LMY-920 in patients with relapsed or refractory myeloma.

Secondary study objectives

To determine incidence of adverse events

To determine incidence of anti- LMY-920 antibodies

To determine the complete response rate per International Myeloma Working Group uniform response criteria after treatment with LMY-920 in patients with relapsed or refractory myeloma.

+5 more

Awards & 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: LMY-920 dose escalationExperimental Treatment1 Intervention

Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.

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 proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), monoclonal antibodies (e.g., daratumumab), and CAR-T cell therapies. Proteasome inhibitors disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs enhance the immune system's ability to attack myeloma cells. Monoclonal antibodies target specific proteins on myeloma cells, marking them for destruction by the immune system. CAR-T cell therapies, such as those expressing B-cell Activating Factor (BAFF), involve modifying a patient's T cells to target and kill myeloma cells. These mechanisms are crucial as they offer targeted approaches to eliminate myeloma cells, potentially leading to better outcomes and fewer side effects for patients.

Anti-BCMA CAR T-cell therapy in multiple myeloma: can we do better?