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

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

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2021 Financial Results (GlobeNewswire) - “Cullinan will provide a regulatory update on CLN-081 on March 28th, 2022….A more extensive preclinical characterization of CLN-049 has been published in the Journal for Immunotherapy of Cancer (JITC)…Initial clinical data are expected by mid-2023; The trial design includes parallel evaluation of CLN-619 as a monotherapy and in combination with checkpoint inhibitor therapy in separate modules. Initial clinical data are expected by mid-2023; [for CLN-617 and CLN-978] Cullinan expects to submit INDs for both programs by the end of the first half of 2023.”

EGFR exon 20 • IND • P1 data • Regulatory • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Cullinan Oncology to Present Data Demonstrating Breadth and Progress of Its Immuno-Oncology Portfolio at AACR 2022 (GlobeNewswire) - "Data for the following programs will be presented: (i) Preclinical characterization of CLN-049 and demonstration of its antitumor activity in AML models; (ii) Preclinical data evaluating the ability of CLN-619 to functionally restore the MICA/MICB-NKG2D axis...; (iii) Preclinical data demonstrating robust anti-tumor activity of CLN-617, locally in injected tumors and systemically in uninjected tumors; (iv) Preclinical characterization of CLN-978, a novel CD19/CD3-bispecific construct with extended serum half-life and high potency against target cells expressing very low levels of CD19; (v) Preclinical data assessing Opal, an earlier stage immuno-oncology program designed to simultaneously block the PD-1/PD-L1/2 axis and conditionally activate the 4-1BB/CD137 pathway on T cells."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Cullinan Oncology, LLC

Clinical • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2

Cullinan Oncology Provides Corporate Update and Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "Cullinan Pearl: Continued advancing the Phase 1/2a trial evaluating CLN-081 in non-small cell lung cancer (NSCLC)...Cullinan intends to provide a clinical update on Pearl in the fourth quarter of 2021; Cullinan MICA: CLN-619...Cullinan remains on track to open for enrollment a first-in-human clinical trial evaluating CLN-619 in patients with advanced solid tumors in the fourth quarter of 2021; Cullinan Florentine: CLN-049 is a bispecific antibody designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells, triggering T cells to kill the targeted cancer cells. Cullinan remains on track to open for enrollment a first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory acute myeloid leukemia in the fourth quarter of 2021."

EGFR exon 20 • Enrollment status • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Cullinan Oncology Provides Corporate Update and Reports Second Quarter 2021 Financial Results (GlobeNewswire) - “CLN-081…intends to provide a clinical and regulatory update in Q4 2021…Cullinan intends to initiate a first-in-human (FIH) trial of CLN-619 in 2H 2021…Cullinan intends to initiate a FIH trial of CLN-049 in 2H 2021…CLN-617, a fusion protein combining two potent antitumor cytokines, IL-2 and IL-12, in a single molecule with a collagen-binding tumor retention domain for the treatment of solid tumors. IND-enabling studies are planned to commence in the 2H 2021.”

New trial • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Cullinan Oncology Reports First Quarter 2021 Financial Results (GlobeNewswire) - "...we initiated Phase 2a dose expansion in the 100 mg BID cohort of our ongoing Phase 1/2a trial evaluating CLN-081 in NSCLC patients with EGFR ex20ins mutations....The poster presentation will contain updated safety and efficacy data subsequent to the November 2020 cutoff and will be available during the conference, which takes place from June 4 – 8, 2021....Continued to advance CLN-619...through IND-enabling activities, including drug product manufacturing, to support an IND submission in the second quarter of 2021."

EGFR exon 20 • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

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 (GlobeNewswire) - “Cullinan Oncology, Inc…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).”

IND • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology