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ShanghaiJune 15, 2026 /PRNewswire/ — CARsgen Therapeutics (Stock Code: 2171.HK), a biopharmaceutical company focused on developing innovative CAR-T cell therapies, announced that research findings on CT0596 (a BCMA-targeting universal CAR-T cell product) and CT1190B (a CD19/CD20-targeting universal CAR-T cell product) were presented as posters at the 2026 European Hematology Association (“EHA”) Annual Meeting.
Data on CT0596 in the Treatment of Relapsed/Refractory Multiple Myeloma and Primary Plasma Cell Leukemia
A total of 8 patients received CT0596 at a dose of 4.5×10⁸ CAR⁺ T cells, including 6 with relapsed/refractory multiple myeloma (R/R MM) and 2 with relapsed/refractory primary plasma cell leukemia (R/R pPCL). All patients had received extensive prior therapy, with a median of 3.5 prior lines of treatment (range: 2-6). The majority of patients had advanced-stage disease (ISS stage III: n=5), 1 had extramedullary disease, and 5 had high-risk cytogenetic abnormalities.
Treatment-emergent adverse events (TEAEs) were reported in all 8 patients, primarily hematologic toxicities, which are common after 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) occurred. No patient withdrew from the trial or died due to adverse events.
As of May 10, 2026, with a median follow-up of 6.97 months, 6 patients maintained remission. A total of 8 patients were evaluable. Six patients achieved stringent complete response (sCR, n=5) or very good partial response (VGPR, n=1) after the first 4.5×10⁸ infusion. One R/R MM patient, who failed initial treatment with a 3.0×10⁸ infusion, received a second treatment at 4.5×10⁸ and maintained partial response (PR) at month 10 post-second infusion. Another overweight pPCL patient (102 kg) experienced progressive disease (PD) after low-intensity lymphodepletion and initial 4.5×10⁸ infusion, then achieved sCR after full lymphodepletion and a 6.0×10⁸ infusion. 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 minimal residual disease (MRD) negativity at a sensitivity of 10⁻⁶ by 4 weeks after effective infusion.
Pharmacokinetic results from the 8 infused patients showed robust and durable cell expansion, with a median Cmax of 100,078 copies/µg gDNA and a median Tmax of 10.5 days.
Data on CT1190B in the Treatment of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
A total of 13 patients (10 with large B-cell lymphoma [LBCL] and 3 with follicular lymphoma [FL]) received CT1190B infusions at doses of: 1.5×10⁸ cells (1 patient), 3.0×10⁸ cells (2 patients), 4.5×10⁸ cells (4 patients), and 6.0×10⁸ cells (6 patients). All patients had received extensive prior therapy, with a median of 3 prior lines of treatment (range: 2-7).
The majority of Grade 3 or higher adverse events were hematologic toxicities, most of which resolved within 28 days. No Grade 3 or higher infections occurred. Eight patients experienced CRS (7 Grade 1-2, 1 Grade 3), all resolving within 11 days. Two patients experienced ICANS (1 ≥ Grade 3 resolving, 1 Grade 1 resolved). No patient withdrew or died 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), and the complete response (CR) rate was 66.7% (8/12), including: 1 PR and 1 CR in the 3.0×10⁸ dose group; 1 PR and 3 CRs in the 4.5×10⁸ dose group; and 1 PR and 4 CRs in the 6.0×10⁸ dose group. All 3 FL patients achieved CR. All 7 LBCL patients treated with lymphodepletion regimen A achieved responses, with a CR rate of 71.4%. Notably, responses were also observed in patients previously treated with CAR-T cells or bispecific antibodies, and all patients treated at moderate or higher doses (≥3.0×10⁸) achieved responses. At a median follow-up of 6.62 months, 7 of the 11 responders maintained disease remission.
CAR-T cell expansion was observed at moderate and high doses, with a median Tmax of 10 days. At the highest dose (6.0×10⁸ cells), the median Cmax (reaching 10⁵) and AUC₀₋ₜ (reaching 6×10⁵) of CT1190B far exceeded those of currently approved autologous CAR-T products (Cmax: 10³–10⁴; AUC₀₋ₜ: 10⁴–2×10⁵).
About CT0596
CT0596 is a BCMA-targeting universal CAR-T cell therapy developed based on CARsgen’s proprietary THANK-u Plus® platform, currently being evaluated in an IIT for R/R MM or PCL. CT0596 has shown an initial favorable safety profile and encouraging efficacy signals. The Company also plans to further explore it in other plasma cell tumors and autoimmune diseases driven by autoreactive plasma cells. The Company plans to initiate a Phase Ib clinical trial for R/R MM and primary plasma cell leukemia in 2026.
About CT1190B
CT1190B is a CD19/CD20-targeting universal CAR-T cell therapy developed based on CARsgen’s THANK-u Plus® platform, currently being evaluated in an IIT for the treatment of R/R B-NHL. The Company plans to initiate a Phase Ib registrational clinical trial for the treatment of R/R B-NHL in 2026.
About CARsgen Therapeutics
CARsgen Therapeutics (Stock Code: 2171.HK) is a biopharmaceutical company focused on developing innovative CAR-T cell therapies to address unmet clinical needs, including but not limited to hematologic malignancies, solid tumors, and autoimmune diseases. The Company has established end-to-end capabilities for CAR-T cell research and development, from target discovery, preclinical research, product clinical development, to commercial-scale production. Through proprietary new technologies and a product pipeline with global rights, the Company aims to address challenges of existing CAR-T cell therapies, such as improving safety, enhancing efficacy in solid tumor treatment, and reducing treatment costs. CARsgen’s mission is to become a global leader in the biopharmaceutical field, providing innovative and differentiated cell therapies for patients with cancer and other diseases worldwide, making cancer and other diseases curable.
Forward-Looking Statements
All statements in this press release that are not historical facts or statements of current facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs, and expectations regarding future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors over which the Group has no control. Therefore, they are subject to significant risks and uncertainties, and actual events or results may differ materially from those expressed in these forward-looking statements, and the forward-looking events discussed in this press release may not occur. These 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 published on our company website at https://www.carsgen.com. We make no representation or warranty, and no reliance should be placed on, the achievement or reasonableness of any projections, targets, estimates, or forecasts in this press release.
Contact CARsgen Therapeutics
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