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ASH 2024 | Results of a Phase I trial of HBI0101, an anti-BCMA CAR T-cell therapy, for R/R multiple myeloma
Eyal Lebel, MD, Hadassah-Hebrew University Medical Center, Jerusalem, Israel, presents the results of a Phase I trial (NCT04720313) evaluating the efficacy of HBI0101 (NXC-201), an anti-BCMA CAR T-cell therapy, for relapsed/refractory (R/R) multiple myeloma (MM). Dr Lebel highlights the promising results observed with this academic CAR-T product, with a response rate of 92% and high rates of measurable residual disease (MRD) negativity. Additionally, the safety profile was comparable to other CAR-T therapies. This study demonstrates the benefits of an academic CAR-T approach with more flexible eligibility criteria, potentially reaching patients with advanced disease. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
So HBI0101 is an academic anti-BCMA CAR-T 4.1BB, second generation. I think that we all know that CAR-T’s are now standard of care, cilta-cel from second-line, ide-cel from third-line, and they outperformed all other therapies for relapsed/refractory myeloma or previous standard of care but there is still a problem with access to this therapy, availability of this therapy because of slots, because of vein-to-vein time, because of cost, and this is where an academic CAR-T takes place and this is where their importance lies and we treated almost, we report now, almost 196 patients with a higher dose of 800 million CAR-T cells...
So HBI0101 is an academic anti-BCMA CAR-T 4.1BB, second generation. I think that we all know that CAR-T’s are now standard of care, cilta-cel from second-line, ide-cel from third-line, and they outperformed all other therapies for relapsed/refractory myeloma or previous standard of care but there is still a problem with access to this therapy, availability of this therapy because of slots, because of vein-to-vein time, because of cost, and this is where an academic CAR-T takes place and this is where their importance lies and we treated almost, we report now, almost 196 patients with a higher dose of 800 million CAR-T cells. Our eligibility criteria were more flexible and more permissive than the registration and study of the commercial CAR-T. The threshold for platelet count, for example, creatinine clearance, performance status, ejection fraction were all more permissive. The efficacy is quite similar to other CAR-T’s, response rate of 92%. Most of them achieved a complete response, MRD negativity in about three quarters of the patients. The PFS is 13 months in this cohort. But we did see a difference between patients that would have been eligible or ineligible for the key registration of commercial CAR studies. And the patients that were eligible, would have been eligible for the other CAR T studies, their outcomes were better. So I think that this cohort is in reach of more advanced patients and of course in the future it will be nice to test this product earlier and this is what we plan in the Phase II study. Toxicity was quite similar to other CAR T’s. We didn’t see actually any grade four or five. We had CRS, we saw four cases of ICANS, all were low grade among 96 patients, so this is quite lower compared to the other CAR-T’s. We had no treatment-related mortality. Of course, hematological toxicity, infections were quite common like the other CAR-T’s, but overall manageable. So I think this is a proof of concept that academic CAR-T’s are important in this field and will enable more patients worldwide to get CAR-T.
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Disclosures
Pfizer: Membership on an entity’s Board of Directors or advisory committees; BMS: Membership on an entity’s Board of Directors or advisory committees.
