GIC-102 / GICELL - LARVOL DELTA

GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: GI Cell, Inc. | Phase classification: P1 ➔ P1/2

Metastases • Monotherapy • Phase classification • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

The promising feeder-free allogenic NK cell therapy: Clinical outcomes of GIC-102 monotherapy (GIC-102101) and synergistic potential with GI-101 (CD80-IgG4 Fc-IL2v) in advanced solid tumors and hematologic malignancies. (ASCO 2024) - P1, P1/2 | "A lympho-conditioning strategy using cyclophosphamide (300 mg/m2) and fludarabine (30 mg/m2) was implemented every two cycles before GIC-102 treatment. The GIC-102, feeder-free allogeneic NK cell, was well tolerated without DLTs and demonstrated early promise in efficacy in patients for advanced solid tumors and hematologic malignancy. Further clinical investigation of GIC-102 in combination with GI-101, bi-specific Fc fusion protein, is currently ongoing. Clinical trial information: NCT05880043."

Clinical • Clinical data • Metastases • Monotherapy • Anemia • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Heart Failure • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD80

GI Innovation announces clinical results of single-use 'GI-102' at 'ASCO' [Google translation] (Yakup Shinmoon) - P1 | N=9 | NCT05880043 | Sponsor: GI Cell, Inc. | "GI Cell also announced clinical results of ‘GIC-102’...According to the abstract, the best response overall was a complete response (CR) in 1/6 patients (NHL) and stable disease (SD) in 4/6 patients (3 CRC, 1 NHL), with CR (NHL) and SD (CRC). Treatment is ongoing (215+ days for NHL/160+ days and 153+ days for CRC)....In vivo studies combining GIC-102 and GI-101 demonstrated antitumor activity lasting up to 4 weeks and enhanced NK cell proliferation in vivo."

P1 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study of GIC-102 (Allogeneic Natural Killer Cells) in Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, and Multiple Myeloma (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: GI Cell, Inc.

Metastases • New P1 trial • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

GI Cell speeds up developing of allogeneic NK cell therapies (Korea Biomedical Review) - "GI Cell has won approval for phase 1 IND (investigational new drug) for allogeneic NK cell therapy....GI Cell said Monday that it has obtained approval for the phase 1 clinical trial of its allogeneic NK cell therapy, GIC-102 (T.O.P. NK), from the Ministry of Food and Drug Safety. Large medical institutions, including Korea University Anam Hospital, Seoul National University Hospital, and Asan Medical Center, will conduct the clinical trial beginning in the first half year. In phase 1 clinical trial, GI Cell plans to confirm the safety, drug resistance, and pharmacokinetics/pharmacodynamics of GIC-1023 in patients with progressive solid cancers, recurrent/refractory non-Hodgkin lymphoma, and multiple myeloma....In phase 1 clinical trial, GI Cell will evaluate not only the administration of GIC-102 alone but also its combined administration with GI Innovation’s double fusion protein, GI-101."

New P1 trial • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

GICELL Announces the Preclinical Research Data Demonstrating the Superiority of the NK Cell Mass Culture Platform at the Society for Immunotherapy of Cancer (Businesswire) - "...GICELL is harnessing its wholly-owned platform to culture NK cells on a large scale without feeder cells which is a safer and simpler way for NK cell therapy...T.O.P. NK shows excellent anticancer activity in tumor-bearing animal models. According to the data in immunodeficient mice (NOG mice) implanted with human cancer cell lines, the growth of various solid tumors (4 types of colorectal cancer, 1 type of head and neck cancer, 1 type of breast cancer) was significantly inhibited by T.O.P. NK administrated via intravenous route compared to the control...Based on these preclinical data, GICELL submitted an IND for a phase 1 clinical trial for patients with solid tumors and hematologic cancer to the Ministry of Food and Drug Safety (MFDS) in September...'We expect to initiate phase 1 clinical trial in earlier 2023'..."

New P1 trial • Preclinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor