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The single-arm trial that won eque-cel its approval in China, with almost every patient responding and most reaching deep remissions.
Multicentre single-arm study reported in JAMA Oncology 2024: objective responses in about 96% of infused patients, high rates of stringent complete response and minimal residual disease negativity, durable responses including in patients previously exposed to CAR-T, and mostly grade 1 to 2 cytokine release syndrome. Basis of NMPA approval in June 2023, China's first fully human BCMA CAR-T.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
103 enrolled.
97 of 101 evaluable patients; 103 infused; median follow-up 13.8 months (data cut September 2022)
Source75 of 103 as reported
SourceMedian PFS not reached
SourceGrade 1-2 in 92.3%; ICANS 1.9% (all grade 1-2)
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall response rate (efficacy-evaluable)primary | Equecabtagene autoleucel 1.0 × 10^6 CAR+ T cells/kg | 101 | 96% | - | - | link |
| Complete response or better | Equecabtagene autoleucel | 103 | 74.3% | - | - | link |
| MRD negativity (10^-5) | Equecabtagene autoleucel | - | 95% | - | - | link |
| Progression-free survival at 12 months | Equecabtagene autoleucel | - | 78.8% | - | - | link |
| Cytokine release syndrome, any grade | Equecabtagene autoleucel | 103 | 93.2% | - | - | link |
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