AI Article Synopsis
- * The trial included 28 patients and showed promising results with an overall response rate of 82%, and a complete response rate of 71%, especially in a subgroup treated with a low dosage of CAR T cells (25×10).
- * With a median follow-up of 24 months, the therapy demonstrated a 1-year event-free survival rate of 61%, while serious side effects were relatively low, indicating the potential for this approach in treating
Article Abstract
We designed a CD19-targeted CAR comprising a calibrated signaling module, termed 1XX, that differs from that of conventional CD28/CD3z and 4-1BB/CD3z CARs. Here we report the first-in-human, phase 1 clinical trial of 19(T2)28z-1XX CAR T cells in relapsed/refractory large B-cell lymphoma. We hypothesized that 1XX CAR T cells may be effective at low doses and investigated 4 doubling dose levels starting from 25×10 CAR T cells. The overall response rate (ORR) was 82% and complete response (CR) rate 71% in the entire cohort (n=28) and 88% ORR and 75% CR in 16 patients treated at 25×10. With the median follow-up of 24 months, the 1-year EFS was 61% (95% CI: 45-82%). Overall, grade ≥3 CRS and ICANS rates were low at 4% and 7%. The calibrated potency of the 1XX CAR affords excellent efficacy at low cell doses and may benefit the treatment of other hematological malignancies, solid tumors and autoimmunity.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247921 | PMC |
| http://dx.doi.org/10.21203/rs.3.rs-4619285/v1 | DOI Listing |
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