CRBU 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• •Vispa-cel: an allogeneic anti-CD19 CAR-T cell therapy that has been evaluated in our multicenter, open-label ANTLER phase 1 clinical trial in patients with relapsed or refractory B cell non-Hodgkin lymphoma (“r/r B-NHL”)

• To our knowledge, vispa-cel is the first clinical-stage allogeneic CAR-T cell therapy with a genome-edited knockout of the PDCD1 gene to prevent PD-1 expression on the CAR-T cell surface. On May 7, 2026, we announced that we reached alignment with the FDA on the design of ANTLER-3, our planned pivot…

• On June 11, 2026, we announced that 85 patients with r/r B-NHL were treated in the ANTLER phase 1 clinical trial. As of the March 6, 2026, data cutoff date, 27 2L LBCL patients received a single dose of vispa-cel manufactured from a donor younger than 30 years old with at least two matched human leu…

• To our knowledge, CB-011 is the first clinical-stage allogeneic CAR-T cell therapy incorporating an immune cloaking approach that includes both the removal of the endogenous beta-2-microglobulin (“B2M”) protein and insertion of a beta-2-microglobulin–human-leukocyte-antigen-E–peptide transgene (“B2M…

• On June 11, 2026, we announced longer follow-up data from the dose escalation portion of our CaMMouflage clinical trial. As of the May 26, 2026, efficacy data cutoff date, the 12-patient, BCMA-naïve cohort treated with the RDE had the following outcomes: an ORR of 92%, a complete response or stringe…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• •Vispacabtagene regedleucel (“vispa-cel,” formerly CB-010): an allogeneic anti-CD19 CAR-T cell therapy that has been evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (“r/r B-NHL”) in our ANTLER phase 1 clinical trial

• To our knowledge, vispa-cel is the first clinical-stage allogeneic CAR-T cell therapy with a genome-edited knockout of the PDCD1 gene to prevent PD-1 expression on the CAR-T cell surface. On November 3, 2025, we announced that, as of the September 2, 2025, safety data cutoff date, 84 patients with r…

• By leveraging our allogeneic CAR-T cell therapy clinical data set of more than 140 patients dosed across multiple clinical trials, we identified key factors that we believe are linked to successful patient outcomes, and we have incorporated these learnings to develop an optimized vispa-cel profile. …

• Vispa-cel is generally well tolerated. As of the September 2, 2025, safety data cutoff date, treatment emergent adverse events (“TEAEs”) at any grade in 25% or greater of all 84 patients who had received vispa-cel were thrombocytopenia (62%), cytokine release syndrome (“CRS”) (55%), anemia (52%), ne…

• We reached alignment with the FDA regarding our vispa-cel pivotal phase 3 clinical trial design following interactions to date with the agency enabled by the RMAT designation for vispa-cel.We plan to evaluate vispa-cel in the ANTLER-3 trial, a randomized, controlled pivotal phase 3 clinical trial in…

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• During the quarter ended June 30, 2026, none of our directors or officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-rule 10b5-1 trading arrangement,” as each item is defined in Ite…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• On February 25, 2026, Tim Kelly, M.B.A., our chief technology officer, entered into a “Rule 10b5-1 trading arrangement” (as that term is defined in Regulation S-K, Item 408) that is intended to qualify as an “eligible sell-to-cover transaction” (as described in Rule 10b5-1(c)(1)(ii)(D)(3) under the …

• Except as described above, no other Section 16 officer or director adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as that term is defined in Regulation S-K, Item 408) during the quarter ended March 31, 2026.