What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those similar to BCMA-directed CAR-T cell therapy like anitocabtagene-autoleucel, include CAR-T cell therapies and other immunotherapies. Known side effects of these treatments can include cytokine release syndrome (CRS), which may cause fever, low blood pressure, and difficulty breathing. Neurological toxicities are also common, potentially leading to confusion, seizures, or encephalopathy. Other side effects may include infections due to immunosuppression, cytopenias (low blood cell counts), and organ toxicities. It is crucial for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including BCMA-directed therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel, which are chimeric antigen receptor (CAR) T cell therapies. Additionally, the anti-BCMA antibody drug conjugate belantamab mafodotin has been approved. Other related treatments include proteasome inhibitors like bortezomib and carfilzomib, immunomodulatory drugs such as lenalidomide and pomalidomide, and monoclonal antibodies like daratumumab and elotuzumab.

What other types of research exist?

Promising alternatives to Anitocabtagene-autoleucel for Multiple Myeloma patients include: 1) Other BCMA-directed CAR-T cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel. 2) Bispecific antibodies like teclistamab, which targets both BCMA and CD3. 3) Novel drug combinations such as selinexor, bortezomib, and dexamethasone, which have shown efficacy in relapsed or refractory multiple myeloma.

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CAR T-cell Therapy

CART-ddBCMA for Multiple Myeloma (iMMagine-1 Trial)

Phase 2

Recruiting

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment called anitocabtagene-autoleucel for patients whose multiple myeloma has returned or not responded to other treatments. The treatment uses the patient's own immune cells, which are modified to better attack the cancer cells.

Who is the study for?

Adults with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including proteasome inhibitors, IMiDs, and anti-CD38 antibodies. They must show measurable disease signs, be in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, and proper organ function. Participants should not be pregnant or breastfeeding and must agree to use effective birth control for a year post-treatment.

What is being tested?

The trial is testing CART-ddBCMA, which is a type of CAR-T cell therapy targeting BCMA on cancer cells. It's for patients whose multiple myeloma has returned after treatment or hasn't responded to standard therapies. The study will assess the safety and effectiveness of this new intervention.

What are the potential side effects?

CAR-T cell therapies like CART-ddBCMA can cause cytokine release syndrome (flu-like symptoms such as fever and fatigue), neurological effects (confusion or difficulty speaking), low blood cell counts leading to increased infection risk, bleeding issues, and potential allergic reactions.

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

Overall Response Rate (ORR)

Secondary study objectives

Anti-anitocabtagene-autoleucel Antibodies

Duration of Response (DoR)

Health Related Quality of Life (HRQoL)

+10 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: anitocabtagene-autoleucelExperimental Treatment1 Intervention

Single dose of 115±10 x 10e-6 CAR+ anitocabtagene-autoleucel cells infused intravenously

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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 target the malignant plasma cells through various mechanisms. Proteasome inhibitors (e.g., bortezomib) disrupt protein degradation, leading to cell death. Immunomodulatory drugs (e.g., lenalidomide) enhance immune response and inhibit tumor growth. Monoclonal antibodies (e.g., daratumumab) target specific antigens on myeloma cells, marking them for destruction by the immune system. BCMA-directed CAR-T cell therapies, like Anitocabtagene-autoleucel, genetically modify a patient's T cells to target and kill myeloma cells expressing the BCMA protein. These treatments are crucial as they offer targeted, effective options for managing and potentially eradicating Multiple Myeloma, improving patient outcomes and survival rates.