QH104 / Suzhou Dushu Lake Hospital, Beijing Qinghui Liannuo Biotechnology - LARVOL DELTA

Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: Dushu Lake Hospital Affiliated to Soochow University | Suspended ➔ Recruiting | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor • CD276

Corporate News | Qinghui Liannuo's universal γδ T cell injection QH104A has been recognized as an orphan drug by the U.S. FDA for malignant glioma indications [Google translation] (bydrug.pharmcube.com) - "On March 19, QH104A, an allogeneic universal CAR-γδ T cell drug targeting B7H3 independently developed by Qinghui Liannuo, a company in Zhongguancun Life Science Park, officially obtained Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of malignant gliomas."

Orphan drug • Glioma

Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection (clinicaltrials.gov) - P1/2 | N=25 | Suspended | Sponsor: Dushu Lake Hospital Affiliated to Soochow University | Recruiting ➔ Suspended

Trial suspension • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor • CD276

The disease control rate is 100%! [Google translation] (Sohu.com) - P1/2 | N=25 | NCT06018363 | "QH104 is an allogeneic universal CAR-γδ T cell drug targeting B7H3 independently developed by Qinghui Liannuo for the treatment of recurrent glioblastoma (rGBM). The data of its first human clinical trial were announced at the ESMO conference....As of March 30, 2024, a total of 7 patients with high-grade recurrent glioblastoma rGBM received more than one intrathecal infusion of QH104. The median observation time was 6.5 months, ranging from 3 to 10 months. Efficacy data showed that the objective response rate (ORR) of the 7 patients was 42.9%, and the disease control rate (DCR) was 100%. QH104 also showed good durability. After 30 days of administration, the injected cells could still be detected by flow cytometry and qPCR. Preliminary stratified analysis found that the clinical efficacy was positively correlated with the expression level of B7H3."

P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

A phase I clinical trial of intrathecal injection of allogeneic CAR-γδT cells targeting B7H3 for the treatment of patients with recurrent glioblastoma (ESMO 2024) - P1/2 | "In summary, these data suggest that QH104 exhibits good safety and holds excellent clinical potential for treating patients with B7H3-positive rGBM."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD276 • IFNG • IL6

Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: Dushu Lake Hospital Affiliated to Soochow University

New P1/2 trial • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor • CD276 • IL10 • IL6