SHANGHAI , June 14, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces poster presentations for CT0596 (an allogeneic CAR T-cell product targeting BCMA), and CT1190B (an allogeneic CAR T-cell product targeting CD19/CD20) at the 2026 Annual Congress of the European Hematology Association ("EHA").

Data for CT0596 in Relapsed/Refractory Multiple Myeloma and Primary Plasma Cell Leukemia

Eight patients, including 6 relapsed/refractory multiple myeloma (R/RMM) and 2 relapsed/refractory primary plasma cell leukemia (R/R pPCL), received CT0596 at the 4.5×10⁸ CAR⁺ T cell dose level. All patients were heavily pretreated, with a median of 3.5 prior lines of therapy (range 2, 6). Most patients had advanced disease (ISS Stage III: n=5), 1 had extramedullary disease, and 5 patients had high-risk cytogenetics.

All 8 patients reported treatment-emergent adverse events (TEAEs), primarily hematologic toxicities, which are common adverse events following CAR-T infusion. No grade ≥3 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS) and no graft-versus-host disease (GVHD) were observed. No treatment-related deaths or study discontinuation due to AE.

As of May 10, 2026, with a median follow-up of 6.97 months, 6 patients maintained responses. All 8 patients were evaluable for efficacy. Six patients achieved stringent complete response (sCR) (n=5) or very good partial response (VGPR) (n=1) following the initial 4.5×10⁸ infusion. One R/R MM patient achieved partial response (PR) and ongoing response at Month 10 after retreatment with 4.5×10⁸, following failure of initial 3.0×10⁸ infusion. One overweight pPCL patient (102 kg) who received reduced intensity lymphodepletion progressed after the initial 4.5×10⁸ infusion, but achieved sCR following retreatment with full-dose lymphodepletion and 6.0×10⁸. By disease subtype analysis, both pPCL patients achieved sCR. Among the 6 MM patients, 4 achieved sCR, 1 achieved VGPR, and 1 achieved PR. All patients achieved MRD negativity at a sensitivity of 10⁻⁶ at 4 weeks after the effective infusion.

Pharmacokinetic results from the 8 infused patients demonstrated robust and persistent cell expansion, with median C_max of 100,078 copies/µg gDNA and median T_max of 10.5 days.

Data for CT1190B in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

A total of 13 patients (10 with large B-cell lymphoma [LBCL] and 3 with follicular lymphoma

[FL]) received CT1190B infusion, with 1, 2, 4, and 6 patients dosed with 1.5×10⁸, 3.0×10⁸, 4.5×10⁸, and 6.0×10⁸ cells, respectively. All patients were heavily pretreated, with a median of 3 prior lines of therapy (range 2-7).

The majority of grade ≥3 adverse events were hematological toxicities, of which most recovered within 28 days. No grade ≥3 infections occurred. CRS was observed in 8 patients (7 grade 1-2, 1 grade 3) and all recovered within 11 days. ICANS occurred in 2 patients (one grade ≥3 resolving, one grade 1 resolved). No study discontinuations or deaths due to adverse events.

As of May 11, 2026, 12 patients were evaluable for efficacy. The objective response rate (ORR) was 91.7% (11/12) with complete response (CR) rate of 66.7% (8/12), including: 1 partial response (PR) and 1 CR at 3.0×10⁸; 1 PR and 3 CR at 4.5×10⁸; 1 PR and 4 CR at 6.0×10⁸. All 3 FL patients achieved CR. All 7 LBCL patients under lymphodepletion regimen A achieved response with a CR rate of 71.4%. Notably, responses were observed even in patients with prior CAR T-cell or bispecific antibody therapy exposure, and all patients treated at intermediate or higher doses (≥3.0×10⁸) achieved response. With a median follow-up of 6.62 months, 7 out of 11 responders maintained ongoing response.

CAR T-cell expansion was observed across intermediate and higher doses with a median T_max of 10 days. At the highest dose level (6.0×10⁸ cells), the median C_max (reaching 10⁵) and AUC_0-t (reaching 6×10⁵) of CT1190B far exceeded those of currently approved autologous CAR‑T products (C_max: 10³–10⁴; AUC _0-t: 10⁴–2×10⁵).

About CT0596

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen's proprietary THANK-u Plus^® platform. It is currently being evaluated in IITs for R/R MM or PCL. CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. The Company plans to initiate Phase Ib clinical trials for R/R MM and primary PCL in 2026.

About CT1190B

CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy developed based on CARsgen's THANK-u Plus^® platform. IITs for R/R B-NHL are ongoing. 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

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