Drugs / CLN-619
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06381141 | Sep 2024 → Sep 2026 overdue | plasma cell myeloma | Cullinan Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05117476 | Oct 2021 → Mar 2026 overdue | non-small cell lung carcinoma | Cullinan Therapeutics Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-05-23 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics to Present First Data for CLN-619, a Novel Anti-MICA/B Antibody, in Combination with a Checkpoint Inhibitor and Updated Monotherapy Data at ASCO 2024 cullinantherapeutics.com ↗
Preliminary data from CLN-619 in combination with checkpoint inhibitor pembrolizumab show objective responses in patients with tumor types that are typically unresponsive to pembrolizumab, such as non-small cell lung cancer (NSCLC) with oncogenic mutations |
| 2024-03-01 | Cullinan Therapeutics Inc. | Regulatory Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma cullinantherapeutics.com ↗
Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. |
| 2023-11-08 | Cullinan Therapeutics Inc. | Results Cullinan Oncology Provides Corporate Update and Reports Third Quarter 2023 Financial Results cullinantherapeutics.com ↗
Initial CLN-619 clinical biomarker data support mechanism of action and demonstrate monotherapy clinical activity in patients with tumors not typically responsive to checkpoint inhibitor therapy |
| 2023-11-03 | Cullinan Therapeutics Inc. | Results Cullinan Oncology to Present Data Demonstrating Progress Across Its Broad Immunotherapy-Pipeline at SITC 2023 cullinantherapeutics.com ↗
Preliminary clinical biomarker data for anti-MICA/B antibody, CLN-619, supports proposed mechanism of action and demonstrates that the observed monotherapy clinical activity was seen in patients with tumors not typically responsive to checkpoint inhibitor therapy |
| 2023-05-25 | Cullinan Therapeutics Inc. | Results Cullinan Oncology to Present First Monotherapy Clinical Data for CLN-619, a Novel Anti-MICA/B Antibody, at ASCO 2023 cullinantherapeutics.com ↗
today announced first monotherapy clinical data from its Phase 1 study of CLN-619 in patients with advanced solid tumors. |
| 2022-03-08 | Cullinan Therapeutics Inc. | Results Cullinan Oncology to Present Data Demonstrating Breadth and Progress of Its Immuno-Oncology Portfolio at AACR 2022 cullinantherapeutics.com ↗
Preclinical data evaluating the ability of CLN-619 to functionally restore the MICA/MICB-NKG2D axis and enhance the binding of MICA to NKG2D on NK cells. |
| 2021-06-29 | Cullinan Therapeutics Inc. | Regulatory Cullinan Oncology Receives FDA Clearance of Investigational New Drug (IND) Application for CLN-619, a Novel MICA/B-targeted Antibody for the Treatment of Solid Tumors cullinantherapeutics.com ↗
Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan MICA’s IND application for CLN-619. |
All press releases naming this drug 11 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CLN-619 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05117476 ↗ |
| Modality | Monoclonal antibody | “Anti-MICA/MICB monoclonal antibody” NCT05117476 ↗ |
| Target | MICA | “Anti-MICA/MICB antibody” NCT05117476 ↗ |
| Target | MICB | “Anti-MICA/MICB antibody” NCT05117476 ↗ |