CT0590 / CARsgen - LARVOL DELTA

A First-in-Human Study of CT0590, a Triple Knock-out, Allogeneic CAR T-Cell Therapy Targeting BCMA and NKG2A, in Subjects with Relapsed/Refractory Multiple Myeloma (ASH 2024) - P=N/A | "All subjects underwent a lymphodepleting regimen consisting of fludarabine (30 mg/m2) and cyclophosphamide (500 mg/m2) for 3 consecutive days, followed by infusion of CT0590. NKG2A expression level at screening may be predictive of clinical response. Enrollment is ongoing to further evaluate the clinical activity of CT0590."

CAR T-Cell Therapy • Clinical • First-in-human • IO biomarker • P1 data • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia • Pneumonia • Respiratory Diseases • B2M • KLRC1

CARsgen Therapeutics Introduced Zhuhai SB Xinchuang to Accelerate Allogeneic CAR-T Cell Products Development in Mainland China (PRNewswire) - "CARsgen Therapeutics...announces reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) ('Zhuhai SB Xinchuang') to jointly invest in UCARsgen Biotech Limited ('UCARsgen')....Under the agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies."

Licensing / partnership • Hematological Malignancies • Multiple Myeloma

CARsgen's First Enrolled Subject in the THANK-u Plus Platform-Based Allogeneic CAR-T Trial Achieves sCR at Week 4 (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that the first subject treated with an allogeneic BCMA CAR-T therapy developed on the THANK-u Plus platform, has achieved stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment....After disease progression following the most recent treatment, the patient was enrolled in the clinical trial. Following infusion of CAR‑T cells at the lowest dose level according to the clinical protocol, the patient experienced Grade 1 cytokine release syndrome (CRS), which was effectively managed with antipyretics and tocilizumab, and the patient did not show immune effector cell-associated neurotoxicity syndrome (ICANS) or other CAR-T-related immune adverse events, demonstrating an overall favorable safety profile....Additional data updates are anticipated in the second half of this year."

Clinical data • Multiple Myeloma

CARsgen completed the dosing of the first subject of IIT for the generic CAR-T product developed based on the THANK-u Plus platform [Google translation] (bydrug.pharmcube.com) - "CARsgen...announced that the company's first generic BCMA-targeting CAR-T cell product candidate developed based on the THANK-u Plus platform has completed the enrollment and dosing of the first subject in an investigator-initiated clinical trial (IIT)....CARsgen is developing a number of general-purpose CAR-T pipeline products, and a number of IITs are scheduled to be launched at the end of 2024 or planned to be launched in the first half of 2025."

Enrollment closed • New trial • Trial status • Multiple Myeloma

A First-in-Human Study of CT0590, a Triple Knock-out, Allogeneic CAR T-Cell Therapy Targeting BCMA and NKG2A, in Subjects with Relapsed/Refractory Multiple Myeloma (PRNewswire) - P1 | N=24 | NCT05066022 | "CARsgen Therapeutics Holdings Limited...announces that the Company will present the clinical data of...CT0590 as posters at the 66th Annual Congress of the American Society of Hematology....As of 22-Apr-2024, 5 subjects were enrolled (4 subjects with RRMM and 1 subject with primary plasma cell leukemia [pPCL] under compassionate use)....No dose limiting toxicities were reported and there were no withdrawal from the study or deaths due to adverse events. With a median follow-up time of 16.6 months (range: 5.1, 24.2), 3 subjects achieved confirmed responses including 2 subjects with stringent complete response (sCR) and 1 subject with partial response (PR). The 2 subjects with sCR include1 RRMM subject [sCR ongoing] with a DOR longer than 23 months as of data cut-off date and 1 pPCL subject with a duration of response (DOR) of 20 months."

P1 data • Leukemia • Multiple Myeloma

VOLUNTARY ANNOUNCEMENT TO PRESENT ZEVORCABTAGENE AUTOLEUCEL, CT071 AND CT0590 AT ASH 2024 ANNUAL CONGRESS (HKEXnews) - "The board of directors of the Company...announces that the Company will present the clinical data of zevorcabtagene autoleucel...CT071 (an autologous CAR T-cell therapy candidate targeting GPRC5D), and CT0590 (an allogeneic CAR T-cell product candidate against BCMA) at the 66th Annual Congress of the American Society of Hematology ('ASH'). Abstracts and further details will be announced after November 5, 2024 Eastern Time."

Clinical data • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

CARsgen Announces 2024 Interim Results (PRNewswire) - "CARsgen has been collaborating with Huadong Medicine for the commercialization of zevor-cel in mainland China. As of July 31, 2024, zevor-cel had been included in nearly 20 provincial or municipal government-subsidized insurance programs and private health insurance products; certification and regulatory filings had been completed in over 100 healthcare institutions across 19 provinces or cities nationwide; we had received a total of 52 orders from Huadong Medicine...The Group's revenue was over RMB6 million for the six months ended June 30, 2024 mainly from zevor-cel in which the primary revenue of zevor-cel was calculated on the basis of ex-works price, rather than on the basis of end-of-market prices....Besides, the Company received a milestone payment of RMB75 million from Huadong Medicine for zevor-cel for the six months ended June 30, 2024....Data updates for CT071 and CT0590 are to be disclosed in the second half of 2024."

Clinical data • Commercial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Access the Safety and Efficacy of CT0590 in Patients With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P=N/A; N=24; Recruiting; Sponsor: The First Affiliated Hospital of Soochow University; Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Clinical • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology