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ASH 2025 | Initial results from the NEXICART-2 trial of BCMA-directed CAR-T (NXC-201) in R/R AL amyloidosis
Heather Landau, MD, Memorial Sloan Kettering Cancer Center, New York, NY, discusses data from the first 20 patients treated in the NEXICART-2 trial (NCT06097832), a Phase I/II dose escalation and expansion study of the BCMA-directed CAR T-cell therapy NXC-201 in patients with relapsed/refractory (R/R) light chain (AL) amyloidosis. Dr Landau suggests that this CAR-T construct may potentially address a significant unmet clinical need, as she notes that no FDA-approved therapies exist in this patient population. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The NEXICART-2 study is the first trial of a BCMA-directed CAR T-cell in patients with relapsed and refractory AL amyloidosis – that is a patient population that has a true unmet medical need where there is not a single FDA-approved therapy for that condition. And so what we did is we enrolled patients who had at least one line of prior therapy, including an anti-CD38 antibody and a proteasome inhibitor, in this trial that opened in June of 2024...
The NEXICART-2 study is the first trial of a BCMA-directed CAR T-cell in patients with relapsed and refractory AL amyloidosis – that is a patient population that has a true unmet medical need where there is not a single FDA-approved therapy for that condition. And so what we did is we enrolled patients who had at least one line of prior therapy, including an anti-CD38 antibody and a proteasome inhibitor, in this trial that opened in June of 2024. And we are reporting on 20 patients. So they were treated with NXC-201, which is a novel BCMA-directed CAR T-cell. And after a dose escalation, we are now in the dose expansion. So three patients were treated with a dose of 150 times 10 to the power of 6 CAR T-cells and the rest of the patients with 450 million cells.
And amongst the 20 patients who have been treated, the bottom line is over 75% of patients have a complete hematologic response, meaning normalization of their free light chain or paraprotein and immunofixation negative in both the serum and urine. For additional patients, MRD is negative in the bone marrow, but what we see with this therapy is that there’s rapid and prompt reduction of the paraprotein, particularly the free light chains, but also the M-spike. But the immunofixation tends to be positive for a lot longer, such that four additional patients are MRD negative in the bone marrow, but have not yet achieved a complete hematologic response based on persistent immunofixation positivity.
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