CLN-049 / Cullinan Therap, University of Tuebingen, German Cancer Research Center - LARVOL DELTA

Preliminary anti-leukemia activity from A phase 1 study of cln-049, a novel anti-FLT3 x anti-CD3 bispecific T-cell engager, in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS) (ASH 2025) - P1 | "Responses were also observed in pts with TP53-mutated AML, a population with aparticularly poor prognosis. Dose escalation continues in this ongoing study."

IO biomarker • P1 data • Acute Myelogenous Leukemia • Dental Disorders • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukemia • Myelodysplastic Syndrome • Neutropenia • Pneumonia • Renal Disease • Respiratory Diseases • Stomatitis • FLT3 • TP53

Portfolio Highlights and 2026 Milestones: CLN-049 (FLT3xCD3 T cell engager) (GlobeNewswire) - "Following a positive End-of-Phase 1 meeting with the U.S. FDA in July, the Company will initiate a potentially registrational Phase 2 study in patients with relapsed/refractory AML in Q3 2026....The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in Q4 2026. In Q4 2026, the Company will initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML."

New P1/2 trial • New P2 trial • P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Cullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML (GlobeNewswire) - "The EOP1 meeting focused on the planned Phase 2 development strategy for CLN-049. Based on discussions with the FDA, Cullinan will initiate a potentially registrational Phase 2 study of CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026. The study design agreed with the FDA incorporates a short dose-optimization phase with seamless progression to a single-arm cohort at the recommended Phase 2 dose....The Company will also initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML (NCT07722767)."

FDA event • New P2 trial • Trial status • Acute Myelogenous Leukemia

A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Cullinan Therapeutics Inc.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia (GlobeNewswire) - "CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00)."

Orphan drug • Trial status • Acute Myelogenous Leukemia

CLN-049 (FLT3xCD3 T cell engager): acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (The Manila Times) - "The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in H2 2026. Dose level expansion continues in order to determine the recommended Phase 2 dose (RP2D) by Q4 2026 for a potential single-arm pivotal registrational trial; In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in patients with previously untreated AML; Enrollment continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy."

Enrollment status • New P1/2 trial • P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

2026 Milestones:…CLN-049 (FLT3xCD3 bispecific T cell engager) (GlobeNewswire) - "(i) The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in H2 2026; (ii) In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML; (iii) In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial; (iv) In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML."

New P1/2 trial • P1 data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (The Manila Times) - "The Company plans to share an update from the dose escalation portion of the study in H2 2026...In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial....In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML."

New P1/2 trial • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Cullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049, Novel FLT3xCD3 T Cell Engager, in Oral Presentation at the 67th ASH Meeting (GlobeNewswire) - "As of the August 2025 data cutoff, 45 patients (39 AML, 3 MDS/AML, and 3 MDS) were enrolled....At the highest target dose studied thus far of 12 µg/kg (n=16), CR/CRh rate was 31% (5/16) and CRc rate was 31% (5/16). Anti-leukemic activity was observed at target doses ≥6 µg/kg (n=32), with a CR/CRh rate of 25% (8/32) and a CRc rate of 28% (9/32)....At efficacious doses (≥6 µg/kg), in the patients achieving a CR/CRh response, 63% (5/8) of patients had a duration of response of >16 weeks and 2 additional patients were able to proceed to allogeneic hematopoietic stem cell transplant....Notably, among the 8 patients with TP53-mutated AML treated at 12 µg/kg, 50% (4/8) of patients achieved a CR/CRh response: 3 patients achieved a CRh response and 1 patient achieved a CR; 3/4 patients with CR/CRh had responses that were durable >16 weeks."

P1 data • P53mut • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Cullinan Therapeutics Receives FDA Fast Track Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia (GlobeNewswire) - "Data from the Phase 1 clinical trial of CLN-049 will be presented at the upcoming 67th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on December 8...Initial results from our Phase 1 study have shown meaningful efficacy, including complete responses, reinforcing the broad potential of this FLT3-directed T cell engager in a population where effective treatment options are currently limited and fragmented."

Fast track • P1 data • Acute Myelogenous Leukemia

CLN-049-001: CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | Trial completion date: Nov 2025 ➔ Jun 2027 | Trial primary completion date: Aug 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology

A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study of Cln‑049 for the Treatment of Acute Myeloid Leukemia Patients with Measurable Residual Disease (ASH 2024) - "CLN-049 is a humanized bispecific antibody, with dual binding specificities for FLT3 and CD3, on a human immunoglobulin G1 backbone with a silenced Fragment crystallizable domain...Approximately 70 patients (50 in dose escalation and 20 in dose expansion) will be enrolled at 12 sites in Germany and Spain, including both community and academic centers. The study is currently enrolling in Germany and Spain (EU CT : 2023-506572-27-00)."

Clinical • P1 data • Residual disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • FLT3

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 (GlobeNewswire) - "As of the June 2025 data cutoff, 40 patients (34 AML, 6 MDS) were enrolled without regard to FLT3 cell surface expression across 7 cohorts (target dose range 1.5-12 μg/kg), and 29 patients with AML were efficacy evaluable (≥1 response assessment)....Anti-leukemic activity was observed at target doses ≥6 μg/kg (n=23, all AML), with a CRc rate of 30%, and ORR of 57%. At the highest target dose studied thus far of 12 μg/kg (n=13), CRc rate was 31% and ORR was 69%. In 9/23 patients achieving bone marrow blasts 6 months."

P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Rational design of next-generation FLT3 inhibitors in acute myeloid leukemia: From laboratory to clinics. (PubMed, Eur J Med Chem) - "First-generation multi-kinase inhibitors like midostaurin and second-generation agents such as gilteritinib and quizartinib have shown success. It discusses how these agents, including small-molecule like STI-8591, compounds 36 and 80 and novel therapeutic strategies such as CLN-049, and SENTI-202, are designed to combat resistance. The goal is to provide a medicinal chemistry perspective to provide insights for the design of novel small-molecule FLT3i."

Journal • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): Enrollment continues in the ongoing Phase 1 study in patients with relapsed/refractory AML or MDS, and in the ongoing Phase 1 study in patients with measurable residual disease (MRD) in AML; CLN-617 (IL-2 and IL-12 cytokine fusion protein): Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors."

Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

ATG-107, a novel 2+1 CD3-based T cell engager (TCE) targeting FLT3, demonstrates potent preclinical efficacy for the treatment of AML (SITC 2024) - "BMK is an analog of CLN-049, produced using sequences from the patent WO2020053300A1. WT, wildtype; ITD, Internal tandem duplication. Antibody induced T cell activation (middle) and T cell dependent cellular cytotoxicity (TDCC, bottom) in presence of EOL-1, THP-1, MOLM-13 and MV4-11 were also shown in D, E, F and G, respectively"

Preclinical • Acute Myelogenous Leukemia • Oncology • CD69 • FLT3 • IL2RA

ATG-107, a novel 2+1 CD3-based T cell engager (TCE) targeting FLT3, demonstrates potent preclinical efficacy for the treatment of AML (SITC 2024) - "BMK is an analog of CLN-049, produced using sequences from the patent WO2020053300A1. WT, wildtype; ITD, Internal tandem duplication. Antibody induced T cell activation (middle) and T cell dependent cellular cytotoxicity (TDCC, bottom) in presence of EOL-1, THP-1, MOLM-13 and MV4-11 were also shown in D, E, F and G, respectively"

Preclinical • Acute Myelogenous Leukemia • Oncology • CD69 • FLT3 • IL2RA

Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody):...Following a review of the data from the Phase 1 study of CLN-049, Cullinan is reporting that in the ongoing Phase 1 study in patients with relapsed/refractory AML and MDS, dose-limiting injection site reactions were observed during dose escalation with subcutaneous administration. Based on these findings, together with observations of preliminary clinical activity, dose escalation is now continuing in the study with IV administration."

Adverse events • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results (GlobeNewswire) - "Zipalertinib: Cullinan expects to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study in patients with EGFR ex20ins NSCLC who have progressed after prior systemic therapy, with or without exon 20 targeted therapy, by year-end 2024; CLN-049: Cullinan expects to provide a clinical data update from the ongoing Phase 1 multi-ascending dose study in r/r AML and MDS patients in the second half of 2024."

Enrollment status • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Cullinan Oncology Provides Corporate Update and Reports Third Quarter 2023 Financial Results (GlobeNewswire) - "Upcoming Milestones - CLN-619: Cullinan expects to report initial data from the combination dose escalation module as well as an update on the monotherapy dose escalation module at a medical conference in the second quarter of 2024. Cullinan expects to report initial data from disease specific dose expansion cohorts in the first half of 2025. Zipalertinib: Cullinan expects completion of enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by year-end 2024. CLN-049: Cullinan expects to provide a clinical data update in the second half of 2024. CLN-418: Cullinan expects to provide a clinical data update in the second half of 2024."

Clinical data • P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A PHASE 1 STUDY TO INVESTIGATE CLN-049, A FLT3/CD3 BISPECIFIC T CELL ENGAGER, IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) ACUTE MYELOID LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS) (EHA 2023) - P1 | "Eligible pts include adults with AML R/R to standard induction chemotherapy or venetoclax-based regimens and MDS R/R to hypomethylating agents (HMA)-based treatment...The first pt (baseline 47% BM blasts and receiving hydroxyurea to control leukocytosis) experienced Grade 2 CRS 5.5 hours after infusion that resolved within 24 hours with supportive care... Safety and PK data from the SAD portion supported initiation of the MAD study. Measurable cytokine induction consistent with biological activity was observed at the initial IV dose level tested. Enrollment to the Part C SC dose escalation is ongoing, and updated data will be presented."

Clinical • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Myelodysplastic Syndrome • Oncology • FLT3 • IL10 • IL6

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Cullinan Oncology, LLC | Trial completion date: Jul 2022 ➔ Nov 2025 | Trial primary completion date: Jul 2022 ➔ Aug 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Cullinan Oncology Provides Corporate Update and Reports Third Quarter 2022 Financial Results (GlobeNewswire) - "Portfolio Highlights...CLN-049: CLN-049 is a FLT3/CD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). CLN-049 is currently in Phase I investigation with initial clinical data expected in mid-2023; CLN-619...CLN-619 has broad therapeutic potential and is being investigated as both monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase I study in patients with advanced solid tumors with initial clinical data expected in mid-2023."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Solid Tumor

CLN-049 is a bispecific T cell engaging IgG-like antibody targeting FLT3 on AML cells (AACR 2022) - "In summary, CLN-049 is a promising FLT3-targeted T cell engaging antibody construct expected to have robust anti-tumor activity in the clinic against AML. CLN-049 is currently in a phase 1 clinical trial for the treatment of patients with relapsed/refractory AML."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD4 • CD8 • FLT3

A novel IgG-based FLT3xCD3 bispecific antibody for the treatment of AML and B-ALL. (PubMed, J Immunother Cancer) - "CLN-049 has a favorable efficacy and safety profile in preclinical models, warranting evaluation of its antileukemic activity in the clinic."

IO biomarker • Journal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD123 • CD19 • CD22 • CD33 • CD4 • CD8 • FLT3