What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including CAR T-cell therapies targeting BCMA, often have side effects such as cytokine release syndrome (CRS), which can cause fever, fatigue, and hypotension. Neurological toxicities, including confusion and seizures, are also reported. Other treatments like proteasome inhibitors (e.g., bortezomib) can cause peripheral neuropathy, gastrointestinal issues, and hematologic toxicities. Immunomodulatory drugs (e.g., lenalidomide) may lead to blood clots, fatigue, and increased risk of infections. Monoclonal antibodies (e.g., daratumumab) can cause infusion-related reactions, respiratory infections, and cytopenias.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including CAR T-cell therapies and drugs targeting BCMA. Notably, idecabtagene vicleucel and ciltacabtagene autoleucel are CAR T-cell therapies targeting BCMA that have received FDA approval. Additionally, the anti-BCMA antibody-drug conjugate belantamab mafodotin has been approved for use in Multiple Myeloma. Other FDA-approved treatments include proteasome inhibitors like bortezomib, immunomodulatory drugs such as lenalidomide, and monoclonal antibodies like daratumumab. These therapies have significantly advanced the management of Multiple Myeloma, offering various mechanisms of action to target the disease.

What other types of research exist?

Promising alternatives to GC012F for Multiple Myeloma patients include: 1) Pomalidomide, bortezomib, and dexamethasone (OPTIMISMM study), 2) Carfilzomib, dexamethasone, and daratumumab (CANDOR study), 3) Selinexor, bortezomib, and dexamethasone (phase 3 trial), and 4) Elotuzumab plus lenalidomide and dexamethasone (ELOQUENT-2 trial). These therapies have shown efficacy in relapsed or refractory Multiple Myeloma and are viable options for treatment consideration in 2024.

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CAR T-cell Therapy

CAR T Therapy for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Have an ECOG performance status of 0 or 1

Received at least three prior MM treatment lines of therapy

Must not have

History of severe non-ischemic cardiomyopathy

Received an allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD), or an autologous stem cell transplant ≤12 weeks before apheresis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy using modified immune cells to treat adults with a type of blood cancer that has returned or not responded to treatment. The therapy aims to target and kill cancer cells by recognizing specific proteins on them. This new approach enhances the patient's own immune cells to detect and eliminate cancer cells.

Who is the study for?

Adults with relapsed/refractory Multiple Myeloma who have tried at least three treatment lines including a PI, IMiD, and an antiCD38 antibody. They must have measurable disease, good bone marrow and organ function, be over 18 years old with an ECOG status of 0 or 1. Exclusions include other cancers within the last two years (except certain skin cancers), severe heart issues, CNS involvement by myeloma, specific related diseases like POEMS syndrome or AL amyloidosis.

What is being tested?

The trial is testing GC012F, a dual-targeting CAR T therapy aimed at CD19 and BCMA in patients with multiple myeloma that has come back or hasn't responded to treatment. It's an early-phase study where all participants receive the experimental therapy to evaluate its safety and effectiveness.

What are the potential side effects?

Potential side effects may include immune system reactions due to cell targeting which can affect normal cells as well as cancerous ones; symptoms could range from mild allergic responses to more serious conditions affecting blood counts or organ functions.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have undergone at least three different treatments for multiple myeloma.

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I've been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

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My condition is officially diagnosed as multiple myeloma.

Exclusion Criteria

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

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I have a history of severe heart muscle disease not caused by poor blood flow.

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I had a stem cell transplant less than 6 months ago and have no GVHD.

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My multiple myeloma has affected or is affecting my brain or spinal cord.

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I have a specific blood cancer or related condition.

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I have had serious heart rhythm problems or fainting spells not caused by dehydration.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1b Adverse Events (AEs)

Phase 1b Dose-limiting toxicities

Phase 2 Overall response rate (ORR)

Secondary study objectives

Phase 1b Pharmacokinetic - AUC

Phase 1b Pharmacokinetic - Cmax

Phase 1b Pharmacokinetic - Tmax

+7 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: GC012F (AZD0120)Experimental Treatment1 Intervention

GC012F (AZD0120) will be administrated in one infusion

0 / 10Eligibility 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

Multiple Myeloma treatments often target specific proteins or pathways critical to the survival and proliferation of myeloma cells. Proteasome inhibitors like bortezomib disrupt protein degradation, 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 antigens on myeloma cells, marking them for destruction by the immune system. CAR T-cell therapies, including the CD19/BCMA dual-targeting approach in the GC012F trial, involve modifying a patient's T-cells to express receptors that specifically recognize and kill myeloma cells. These mechanisms are crucial as they offer targeted, effective strategies to combat the disease, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.