CLN-978 / Cullinan Therap - LARVOL DELTA

A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study of CLN-978 (CD19XCD3XHSA) in Patients with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL) (ASH 2023) - P1 | "Approximately 90 patients (30 in dose escalation and 60 in dose expansion) will be enrolled at approximately 6 sites in the U.S., reflecting both community and academic centers. The study is currently enrolling (NCT05879744)."

Clinical • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Transplantation • CD19

Cullinan Therapeutics Shares Additional Preclinical B Cell Depletion Data for CLN-978, Supporting Clinical Development Across Multiple Autoimmune Diseases, at ACR Convergence 2025 (GlobeNewswire) - "New in vitro preclinical data show CLN-978 robustly and specifically depleted target B cells while activating T cells in human peripheral blood mononuclear cells (PBMC) derived from patients with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE)....In a murine model of SLE, CLN-978 treatment led to a reduction in circulating B cells, levels of anti-dsDNA IgG, and IgG deposition in the kidney, indicating a disease-modifying effect in both peripheral blood and affected disease tissues."

Preclinical • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus

CLN-978, a CD19 x CD3-Directed T Cell Engager, Leads to Rapid and Deep B Cell Depletion In Vitro and In Vivo, Supporting Clinical Development Across Multiple Autoimmune Diseases (ACR Convergence 2025) - P1 | "CLN-978 is a highly potent, SC-administered, CD19-directed TCE. Preclinical in vitro and in vivo data including deep B cell depletion in both peripheral blood and tissue, along with existing clinical data in B-NHL patients, support broad development across autoimmune diseases. Phase 1b studies of CLN-978 are currently being conducted in patients with CLN-978 in SjD, SLE, and RA."

Preclinical • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lymphoma • Non-Hodgkin’s Lymphoma • Sjogren's Syndrome • CD19

Portfolio Highlights (GlobeNewswire) - "CLN-978...The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025; The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026....Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases."

New P1 trial • P1 data • Trial status • Immunology • Rheumatoid Arthritis • Systemic Lupus Erythematosus

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Cullinan Therapeutics Inc.

New P1 trial • Immunology • Sjogren's Syndrome

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=37 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=37 | Not yet recruiting | Sponsor: Cullinan Therapeutics Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

CLN-978 (CD19xCD3 T cell engager) (GlobeNewswire) - "The global Phase 1 study in patients with moderate to severe SLE is ongoing in the United States, Europe, and Australia, and the Company plans to share initial clinical data in Q4 2025."

P1 data • Systemic Lupus Erythematosus

Cullinan Therapeutics to Initiate Study of CLN-978, a Bispecific CD19 T Cell Engager Administered Subcutaneously, in Patients with Sjögren’s Disease in the United States (GlobeNewswire) - "Cullinan Therapeutics, Inc....today announced that the Company is initiating a study of CLN-978 in patients with Sjögren’s disease (SjD) in the U.S....The trial will enroll patients with active, moderate to severe Sjögren's disease who fulfill the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria and are positive for anti-SSA/RO antibodies and/or rheumatoid factor....CLN-978 is being studied in people with SLE in the U.S., Australia, and Europe."

New trial • Immunology

Cullinan Therapeutics Receives Approval from European Medicines Agency to Initiate Phase 1 Trial of CLN-978, a Bispecific CD19 T Cell Engager Administered Subcutaneously, in Patients with Rheumatoid Arthritis (GlobeNewswire) - "Cullinan Therapeutics, Inc...announced that the European Medicines Agency (EMA) approved the Company’s Clinical Trial Application (CTA) for CLN-978. The Phase 1 clinical trial will assess CLN-978 in patients with active, difficult-to-treat rheumatoid arthritis meeting the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria....Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025."

IND • New P1 trial • Rheumatoid Arthritis

IndEx-2: An in vitro model to evaluate the impact of target antigen density on antibody and immune therapeutics (AACR 2025) - "In the first, we have compared CLN978, a novel CD19- TCE developed for B-cell malignancies and autoimmune diseases, with Blinatumomab and demonstrated that the former retained its activity in terms of cytotoxicity and cytokine production at much lower levels of CD19 expression and estimate the threshold for each molecule in a cohort of 10 healthy donors. The tandem CAR exhibited enhanced cytotoxicity when either or both antigens were expressed, whereas the dual CAR required co-expression of both antigens for optimal T-cell activation. These results underscore IndEx-2's robustcapability to evaluate the influence of antigen density on therapeutic safety andefficacy, providing a powerful tool for the development of antibody-based and immune-targeting cancer therapies."

IO biomarker • Preclinical • Hematological Malignancies • Oncology • CD19 • CD22 • HER-2 • IFNG

Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "CLN-978 (CD19xCD3 T cell engager): The global Phase 1 study in moderate to severe SLE is ongoing with site expansion in the United States, Europe and Australia, and the Company plans to share initial clinical data in the fourth quarter of 2025; The Company remains on track to initiate a Phase 1 study in rheumatoid arthritis (RA) in the second quarter of 2025."

New P1 trial • P1 data • Trial status • Rheumatoid Arthritis • Systemic Lupus Erythematosus

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases (ACR Convergence 2024) - P1 | "CLN-978 is a highly potent, SC-administered, CD19-directed TCE with both preclinical and clinical data providing a strong rationale for broad development in autoimmune diseases which benefit from B cell depletion."

Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

Cullinan will share details of global Phase 1b study in moderate to severe systemic lupus erythematosus (GlobeNewswire) - "Cullinan Therapeutics....will present...the study schema for a planned Phase 1b study in patients with moderate to severe systemic lupus erythematosus (SLE) will be presented at the annual meeting of the American College of Rheumatology (ACR), ACR Convergence 2024, being held in Washington, D.C., November 14-19....The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have had an inadequate response to at least two treatments...The primary objective of the study is to evaluate the safety of CLN-978 for treatment of active moderate to severe SLE....Initial clinical data are expected in the fourth quarter of 2025."

Clinical protocol • P1 data • Systemic Lupus Erythematosus

Cullinan Therapeutics Announces Preclinical Data for CLN-978, a CD19-directed T Cell Engager, to be Presented at ACR Convergence 2024 (GlobeNewswire) - "CLN-978 Preclinical Data: New in vitro preclinical data show CLN-978 induced similar T cell activation, target B cell depletion, and cytokine production in human peripheral blood mononuclear cells (PBMC) derived from patients with SLE (n=12) or rheumatoid arthritis (RA) (n=9) as compared to healthy volunteers (n=11)....'These new preclinical data further demonstrate that CLN-978 is a highly potent T cell engager. With the ability to be subcutaneously delivered, CLN-978 offers off-the-shelf convenience while achieving significant B cell depletion, supporting its potential as a promising new therapeutic option for autoimmune diseases...'"

Preclinical • Immunology • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Cullinan Therapeutics to Present Preclinical Data for CLN-978, a CD19-directed T Cell Engager, at ACR Convergence 2024 (GlobeNewswire) - "Cullinan Therapeutics....today announced the upcoming presentation of preclinical data for CLN-978, a novel CD19xCD3 bispecific T cell engager, at American College of Rheumatology (ACR) Convergence 2024, taking place in Washington, D.C. from November 14-19, 2024."

Preclinical • Immunology • Systemic Lupus Erythematosus

Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus (GlobeNewswire) - "Cullinan Therapeutics...announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial may proceed in the U.S. to assess CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE). The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have had an inadequate response to at least two treatments, including one immunosuppressive or biologic standard-of-care agent."

IND • Systemic Lupus Erythematosus

A Study of CLN-978, a CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Cullinan Therapeutics Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial of CLN-978 for the Treatment of Systemic Lupus Erythematosus (GlobeNewswire) - "The trial will be conducted in multiple sites in Australia as well as other countries around the world...Cullinan Therapeutics, Inc...received Human Research Ethics Committee (HREC) approval in Australia to initiate its global Phase 1 clinical trial to evaluate CLN-978, its CD19xCD3 bispecific T cell engager, for the treatment of systemic lupus erythematosus (SLE)."

New P1 trial • Lupus • Systemic Lupus Erythematosus

Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus (GlobeNewswire) - "Cullinan Therapeutics, Inc...shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE)."

IND • Immunology • Lupus • Systemic Lupus Erythematosus

A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Cullinan Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Cullinan Therapeutics Announces Strategic Expansion into Autoimmune Diseases (GlobeNewswire) - "In a separate announcement, the company also announced a $280 million private placement. The proceeds from the private placement, combined with current cash, cash equivalents, short term investments and interest receivable, are expected to fund Cullinan's current operating plan into 2028.....The company plans to submit an investigational new drug application to study CLN-978 in patients with SLE in the third quarter of 2024 and is also planning for future development in other autoimmune diseases."

Financing • IND • Systemic Lupus Erythematosus

Correction: CLN-978, a novel half-life extended CD19/CD3/HSA-specific T cell-engaging antibody construct with potent activity against B-cell malignancies with low CD19 expression. (PubMed, J Immunother Cancer) - No abstract available

Journal • Hematological Malignancies • Oncology • CD19

Cullinan Oncology to Present Data Demonstrating Progress Across Its Broad Immunotherapy-Pipeline at SITC 2023 (GlobeNewswire) - "Additional presentations will highlight preclinical data for three other assets: our B7H4X4-1BB bispecific immune activator (CLN-418), our T cell-engaging, CD19-targeted bispecific antibody (CLN-978), and our collagen-binding IL-2/IL-12 fusion protein (CLN-617), as well as a Trials in Progress presentation for CLN-617.”"

Clinical data • Oncology • Solid Tumor