New CAR T for Relapsed/Refractory Myeloma Shows Promising Phase 1 Results

At the European Hematology Association, we had the pleasure of interviewing myeloma specialist Dr. Binod Dhakal, who presented a new treatment for relapsed and refractory multiple myeloma patients with high-risk cytogenetics.

Later, at the International Myeloma Society, he presented updates for anitocabtagene autoleucel (anito-cel/CART-ddBCMA) for relapsed and refractory multiple myeloma patients. 

What is Anitocabtagene Autoleucel? 

What are the Phase I Study Results?

The enrollment included relapsed and refractory multiple myeloma patients who had more than 3 lines of therapy or who had immunomodulatory agents, such as cyclosporine, before. An interesting aspect of the study is that patients with myeloma detected outside of the bone marrow (extramedullary disease), could also participate. 

The results for the phase I clinical trial were promising, with an overall response rate of 100%. This means that all patients responded to the new therapy. Over 76% of those patients achieved a complete response, meaning no myeloma was detected after completing the therapy.  

24 months after the anitocabtagene autoleucel CAR-T was administered, progression-free survival (the time it took for the patients to progress with their myeloma) was estimated at 56%. This means that over half of the patients did not have disease progression two years after the treatment occurred. 

It is important to consider that these are the results from a phase 1 trial that evaluates a medication’s safety, and the results are based on a sample of 38 patients. Although the number of participants is too narrow to give a definitive conclusion; the results motivate researchers to move on to the next phase and involve more patients.

What are the Side Effects of Anitocabtagene Autoleucel?

From the results so far, only one patient presented immune effector cell-associated neurotoxicity syndrome (ICANS), which causes several neurological issues and is common in CAR T-cell therapies. None of the participants presented cytokine release syndrome, which is commonly seen in these types of therapies, and none of the participants presented severe side effects either.

Moving Forward to Phase II

Because of the successful results of the phase one clinical trial, it moved on to phase two. 

This Phase II trial is currently recruiting more participants who have:

• never received BCMA therapy
• never had an allogeneic stem cell bone marrow transplant
• have relapsed and/or refractory multiple myeloma. 

Hopefully, by the beginning of 2025, Dr. Dhakal will share more updates on this promising study.

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