CT-0596 / CARsgen - LARVOL DELTA

A first-in-human study of CT0596, an allogeneic CAR T-cell therapy targeting BCMA, in patients with relapsed/refractory multiple myeloma (ASH 2025) - P1 | "Following lymphodepletion regimen consisting of fludarabine (30 mg/m2) and cyclophosphamide(500 mg/m2) for 3 consecutive days, CT0596 was administered at escalating doses of 1.5×108, 3.0×108 or4.5×108 CAR-positive T cells using i3+3 dose-escalation design. No patients got progression disease, and Pat 01has ongoing sCR and MRD negative for nearly 6 months. CAR T cell expansion was observed in all 8patients.ConclusionThese initial results from this study of CT0596 support the feasibility and safety of allogeneic CAR T-celltherapy for RR MM, thereby warranting further exploration in larger-scale trials."

CAR T-Cell Therapy • Clinical • First-in-human • P1 data • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Leukopenia • Multiple Myeloma • Neutropenia • Plasma Cell Leukemia • Thrombocytopenia • B2M • KLRC1

CARsgen Announces Data of Allogeneic BCMA CAR-T Cell Therapy CT0596 for Relapsed/Refractory Multiple Myeloma at the 2025 ASH Annual Meeting (PRNewswire) - "This clinical trial (NCT06718270) enrolled 8 patients with R/R MM in the dose-escalation phase who received CT0596 infusion....Six patients achieved a partial response (PR) or better: 3 achieved complete response/stringent complete response (CR/sCR) (all in the full-dose lymphodepletion group), 1 achieved very good partial response (VGPR), and 2 achieved PR. Among the 6 patients who received full-dose lymphodepletion, 5 achieved PR or better. Six patients in the full-dose lymphodepletion group achieved minimal residual disease (MRD)-negativity at Week 4....The company plans to initiate a Phase 1b registrational study for CT0596 in 2026."

New P1 trial • P1 data • Multiple Myeloma

Data for CT0596 in Relapsed/Refractory Multiple Myeloma (PRNewswire) - "Five patients achieved partial response (PR) or above: 3 achieved complete response / stringent complete response (CR/sCR) (all of whom had received the full dose of lymphodepletion), 1 achieved PR, and 1 achieved very good partial response (VGPR). Six patients achieved minimal residual disease (MRD)-negativity at Week 4. No patients got progression disease. Pat 01 has ongoing sCR and MRD negative for nearly 6 months. CAR-T cell expansion was observed in all 8 patients. No dose-limiting toxicities (DLT), treatment discontinuations, or deaths were observed."

Clinical data • Multiple Myeloma

Case Report | Preliminary Clinical Data of CARsgen’s Allogeneic BCMA CAR-T Product CT0596 for the Treatment of Primary Plasma Cell Leukemia (The Manila Times) - "pPCL-01: A 62-year-old male with IgG-λ type experienced poor disease control and rapid progression....Following this infusion, he developed Grade 2 CRS, Grade 4 cytopenia, and a lung infection, but recovered after supportive treatment including tocilizumab, corticosteroids, autologous stem cell infusion, and anti-infective therapy....pPCL-02:A 70-year-old male with κ light chain had previously been treated with triple classes of drugs (proteasome inhibitor, immunomodulatory agent, and CD38 monoclonal antibody). The patient developed Grade 1 CRS, Grade 4 neutropenia, and thrombocytopenia following lymphodepletion and CAR-T cell infusion."

Clinical data • Plasma Cell Leukemia

Beyond R/R MM, further investigation is planned in additional plasma cell malignancies... (HKEXnews) - "The Company anticipates submitting an Investigational New Drug (IND) application in the second half of 2025."

IND • Plasma Cell Leukemia

The board of directors of the Company (the “Board”) announces that the Company will present the clinical data of CT0596 (an allogeneic CAR T-cell product candidate against BCMA) at the 67th Annual Congress of the American Society of Hematology (“ASH”) (HKEXnews) - "Abstracts and further details will be announced after November 3, 2025 Eastern Time."

Clinical data • Hematological Malignancies

A Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/ Refractory Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024 ➔ Jul 2025

Enrollment open • Trial initiation date • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

A Study of CT0596 in Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Leukemia • Oncology • Plasma Cell Leukemia

A Study of CT0596 in Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1 trial • Hematological Malignancies • Leukemia • Oncology • Plasma Cell Leukemia

CARsgen Announces Preliminary Clinical Data for Allogeneic BCMA CAR-T CT0596, Demonstrating Favorable Safety and Efficacy (PRNewswire) - P1 | N=24 | NCT06718270 | "As of May 6, 2025, 8 patients with R/R MM who had received at least three prior lines of therapy were enrolled and infused with CT0596 following lymphodepletion with the FC regimen (fludarabine 22.5-30 mg/m² and cyclophosphamide 350-500 mg/m²). Key findings from up to four months of follow-up include:...(i) Among 5 patients who completed the first efficacy assessment at Week 4, 3 patients (60%) achieved stringent complete response/complete response (sCR/CR), and 4 patients (80%) achieved minimal residual disease (MRD)-negativity in the bone marrow; (ii) Early efficacy data from 2 patients at Day 14 showed reductions in measurable lesions by ≥92% and ≥65%, respectively; (iii) 1 patient had not yet reached the protocol-specified efficacy assessment timepoint. All sCR/CR patients remained in ongoing responses, including the first patient who completed the four-month follow-up."

P1 data • Multiple Myeloma

A Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/ Refractory Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University

CAR T-Cell Therapy • New P1 trial • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology