IND Application for CARsgen’s Allogeneic CD19/CD20 CAR-T CT1190B Accepted

SHANGHAI, China, May 21, 2026, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Investigational New Drug (IND) application for CT1190B (an allogeneic CAR T-cell product targeting CD19/CD20) was accepted by the National Medical Products Administration (NMPA). The product is intended to be used for the conduct of a Phase Ib clinical trial in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) who have failed at least two lines of prior standard therapy. CT1190B is developed based on CARsgen's proprietary THANK-u Plus® platform. Through the knockout of genes such as TRAC, and B2M, CT1190B is designed to reduce the risk of graft-versus-host disease (GvHD) and host immune rejection. Additional gene editing further blocks host natural killer (NK) cell-mediated rejection, thereby aiming to enhance the product's efficacy and safety profile. Data from the first-in-human study of CT1190B, as recently released in abstracts at the 2026 Annual Congress of the European Hematology Association (“EHA”), demonstrated a favorable safety profile and encouraging efficacy signals for CT1190B. As of Jan 22, 2026, a total of 13 patients (10 LBCL and 3 FL) received CT1190B infusion. The majority of grade ≥3 adverse events were hematological toxicities, of which most recovered within 28 days. Cytokine release syndrome was observed in 8 patients (7 grade 1-2, 1 grade 3) and all recovered within 11 days. Immune effector cell-associated neurotoxicity syndrome occurred in 2 patients (one grade ≥3 resolving, one grade 1 resolved). No grade ≥3 infections, treatment discontinuations or deaths due to AE were observed. As of Feb 2, 2026, 11 patients were evaluable for efficacy. The objective response rate was 90.9% (10/11) with complete response (CR) rate of 72.7% (8/11). Notably, responses were observed in patients with prior CAR T-cell or bispecific antibody therapy exposure, and all patients treated with the dose of ≥3.0×10⁸ achieved response. About CT1190B CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy developed based on CARsgen’s THANK-u Plus® platform. Ongoing clinical trials include IITs for R/R B-NHL, and for moderate-to-severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc). The Company plans to initiate Phase Ib clinical trials for R/R B-NHL in 2026. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen’s mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading “Principal Risks and Uncertainties” in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit https://www.carsgen.com/ Public Relations: [email protected] Investor Relations: [email protected] Previous Next

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