CARsgen Presents Allogeneic CAR T-cell Products CT0596 and CT1190B at EHA 2026

On June 14, 2026 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported 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) (Free EHA Whitepaper) ("EHA").

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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 Cmax of 100,078 copies/µg gDNA and median Tmax 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 Tmax of 10 days. At the highest dose level (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; 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.

(Press release, Carsgen Therapeutics, JUN 14, 2026, View Source [SID1234668724])