Drugs / CLN-049
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | acute megakaryoblastic leukemia in adult | — | “Cullinan submitted an IND to the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial evaluating CLN-049” cullinantherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05143996 | Nov 2021 → Jan 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | Cullinan Therapeutics Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-05-19 | Cullinan Therapeutics Inc. | Regulatory Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia cullinantherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML). |
| 2025-12-08 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049, Novel FLT3xCD3 T Cell Engager, in Oral Presentation at the 67th ASH Meeting cullinantherapeutics.com ↗
Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today shared updated clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). |
| 2025-12-01 | Cullinan Therapeutics Inc. | Regulatory Cullinan Therapeutics Receives FDA Fast Track Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia cullinantherapeutics.com ↗ |
| 2025-11-03 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics to Showcase New Data Demonstrating Compelling Clinical Activity for CLN-049, a Novel FLT3xCD3 T Cell Engager, in AML Patients in an Oral Presentation at the 67th ASH Annual Meeting cullinantherapeutics.com ↗
CLN-049 demonstrated anti-leukemic activity, including multiple complete responses, in a heavily pretreated population of patients with r/r AML, regardless of FLT3 mutational status |
| 2024-08-08 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results cullinantherapeutics.com ↗
Based on these findings, together with observations of preliminary clinical activity, dose escalation is now continuing in the study with IV administration. |
| 2023-05-11 | Cullinan Therapeutics Inc. | Results Cullinan Oncology Provides Corporate Update and Reports First Quarter 2023 Financial Results cullinantherapeutics.com ↗
preliminary safety data for CLN-049 were published in abstract form today as part of the 2023 EHA Congress and first clinical data for CLN-619 will be presented during a poster session at the upcoming ASCO Annual Meeting. |
| 2021-06-07 | Cullinan Therapeutics Inc. | Regulatory Cullinan Oncology Receives Investigational New Drug (IND) Clearance from the FDA for CLN-049, a FLT3 x CD3 Bispecific Antibody for the Treatment of Relapsed/Refractory AML cullinantherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan Florentine’s IND application for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML). |
| 2021-02-22 | Cullinan Therapeutics Inc. | Regulatory Cullinan Management, Inc. Announces Business Update cullinantherapeutics.com ↗
Based on this information, Cullinan elected to withdraw the IND to determine the most efficient path forward. |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CLN-049 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05143996 ↗ |
| Route | Intravenous | “CLN-049 via IV administration” NCT05143996 ↗ |
| Target | FLT3 | “[FLT3] x [CD3] bispecific T cell engager” NCT05143996 ↗ |