Anito-Cel CAR- T Therapy: A New Option for Relapsed or Refractory Myeloma

Anitocabtagene autoleucel, also called anito-cel, is a type of CAR T-cell therapy that uses your own immune cells to target multiple myeloma. Recent clinical trial results show that anito-cel may offer deep and lasting responses for people whose myeloma has returned or no longer responds to treatment. If you want to learn more details about CAR–T visit our comprehensive guide. 

MULTIPLE MYELOMA CAR-T GUIDE

In this article, you’ll learn the latest results from the iMMagine-1 study presented at the American Society of Hematology (ASH) Annual Meeting. These results present anito-cel as a potential new option for people with relapsed or refractory myeloma. 

What is anito-cel CAR-T?

Anito-cel is an autologous CAR T-cell therapy. This meansit uses a patient’s own T cells. These cells are engineered to target BCMA (B-cell maturation antigen). BCMA is a protein found on myeloma cells. This therapy uses a special “D-domain” binder that helps the treatment attach more efficiently to cancer cells while reducing unnecessary activation of the CAR T cells. This design may help improve performance and lower the risk of side effects.

Anito-cel is currently being studied for people with relapsed or refractory multiple myeloma (RRMM), those whose disease has come back or stopped responding after several earlier treatments.

The most recent results of the anito-cel clinical trial

The Phase 2 iMMagine-1 trial included 117 adults with relapsed or refractory myeloma. They all have received at least three prior lines of therapy, and all were refractory to their most recent treatment. Many also had more challenging disease features:

• 86% were triple-class refractory, meaning that three types of medication classes did not effectively control their disease
• 40% were refractory to five different medications
• 38% had high-risk cytogenetics
• 15% had extramedullary disease, which is when myeloma cells are found outside the bone marrow

Although CAR-T infusions typically happen in the hospital, 9% of patients in this study were able to receive their infusion as outpatients.

What were the study results?

The study showed very encouraging outcomes. The overall response rate (ORR) was 97%, meaning nearly all patients saw their myeloma improve. In addition, 68% achieved a complete response (CR) or stringent complete response (sCR), showing that the therapy can lead to deep remissions. Responses also happened quickly, usually within the first month.

Many patients also achieved minimal residual disease (MRD) negativity, meaning no cancer cells could be detected using highly sensitive testing. Among evaluable patients:

• 93% reached MRD negativity at the 10⁻⁵ level
• 78% reached MRD negativity at the 10⁻⁶ level

At 12 months, 79% of patients remained progression-free, and at 18 months, 66% remained progression-free. Overall survival was 95% at 12 months and 90% at 18 months. Because many patients are still doing well, median PFS and OS have not yet been reached.

What side effects should patients be aware of?

As with all CAR T-cell therapies, side effects can occur, but the safety profile of anito-cel in the trial was manageable.

The most common treatment-related effects were low blood counts, including neutropenia, anemia, and thrombocytopenia. Serious infections were seen in 9% of patients.

• Cytokine release syndrome (CRS) occurred in 85% of participants, but most cases were mild, and nearly all resolved within 10 days.
• Neurologic side effects, including ICANS, occurred in 8% of patients.

Importantly, the study reported no delayed neurologic complications, and no cases of immune effector cell–associated enterocolitis.

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