CLN-978 / Cullinan Therap - LARVOL DELTA

OUTRACE SLE (GlobeNewswire) - "In Q4 2026, the Company plans to share initial multi-dose regimen data. The Company also plans to begin Phase 2 expansion in early 2027 in patients with SLE and in patients with lupus nephritis."

New P2 trial • P1 data • Lupus Nephritis • Systemic Lupus Erythematosus

OUTRACE SjD (GlobeNewswire) - "In Q4 2026, the Company plans to share initial data from the single target dose escalation portion of the study."

P1 data • Immunology • Sjogren's Syndrome

OUTRACE RA (GlobeNewswire) - "In Q3 2026, the Company plans to share additional multi-dose regimen data. The Company also plans to begin Phase 2 expansion in early 2027."

New P2 trial • P1 data • Rheumatoid Arthritis

CLN-978 (CD19xCD3 T cell engager): Treatment-refractory moderate to severe SLE and difficult-to-treat RA (Yahoo Finance) - "New multi-dose data in the Phase 1 OUTRACE RA clinical trial demonstrate the robust efficacy profile of CLN-978 observed in two heavily pre-treated, poly-refractory patients, including a DAS28-ESR remission in one patient: A patient refractory to immediate prior rituximab experienced a DAS28-ESR remission, with a baseline disease score of 4.0 quickly reduced to 2.2 at week 4 and maintained through the latest follow-up at week 8...Safety data for the first three patients with SLE treated with a multi-dose regimen in the Phase 1 OUTRACE SLE clinical trial are consistent with the favorable safety profile observed in the initial RA multi-dose cohort...support planned evaluation of CLN-978 in patients with lupus nephritis, with Phase 2a expansion expected to begin in early 2027...The Company plans to report additional multi-dose regimen data for RA in Q3 2026 and SLE in Q4 2026."

New P2a trial • P1 data • Lupus Nephritis • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Clinical activity and biomarker findings in OUTRACE SLE (GlobeNewswire) - "Among 14 patients with ≥4 weeks follow up, a ≥4-point reduction in hSLEDAI was observed in 10 patients (71%), with 5 achieving a DORIS remission; All lab markers of disease activity (anti-dsDNA, UPCR, C3 and C4) improved in patients with clinically significant abnormalities at baseline; Following a single target dose of CLN-978, peripheral B cell counts were reduced by >80% from baseline in 14 of 17 patients (82%), with dose-dependent recovery: Peripheral B cell depletion below the limit of quantification (BLOQ) was achieved in 7 of 14 patients (50%) treated at target doses ≥20 µg."

P1 data • Systemic Lupus Erythematosus

Clinical activity and biomarker findings in OUTRACE RA (GlobeNewswire) - "In this heavily pretreated population, 6 of 7 patients (86%) had high baseline disease activity. Disease activity improved in 5 of 7 patients (71%), including a DAS28-ESR remission in 1 patient treated with a single 30 μg target dose; CLN-978 reduced RA autoantibody levels without impact on protective vaccine titers; Peripheral blood B cell depletion BLOQ was achieved in 4 of 6 patients (67%) treated at target doses ≥20 µg; Dose dependent B cell depletion was also observed in lymph node and synovial tissue."

P1 data • Rheumatoid Arthritis

CLN-978, a bispecific CD19 x CD3 T cell engager, induces robust B cell depletion in patients with rheumatoid arthritis and systemic lupus erythematosus (EULAR 2026) - "A single target dose of CLN-978 induced robust B cell depletion in both peripheral blood and tissues, with promising clinical efficacy in RA and SLE patients at the initial dose levels tested. Dose escalation continues in these studies, and updated data will be presented."

Bispecific • Clinical • B Cell Lymphoma • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Cullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager (The Manila Times) - "CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe SLE and difficult-to-treat RA: Single target dose escalation data in SLE and RA, as reported at EULAR 2026 Congress on June 6, 2026; Initial data from the first multi-dose cohort of the RA study; Next steps in global clinical development...Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells: Initial data from the first multi-dose cohort of the Genrix Bio study in China; Next steps in global clinical development."

P1 data • Immunology • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Cullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress (GlobeNewswire) - "The presentation will feature data from the Phase 1 OUTRACE RA and OUTRACE SLE studies which are evaluating CLN-978 in patients with active, treatment-refractory rheumatoid arthritis (RA) and moderate to severe systemic lupus erythematosus (SLE), respectively. The abstract reports that single target doses of CLN-978 demonstrate a favorable safety profile at the initial dose levels. Robust B cell depletion in both peripheral blood and tissue was observed, along with early signals of promising clinical activity in patients with RA and SLE."

P1 data • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Portfolio Highlights and 2026 Milestones (The Manila Times) - "Initial clinical data in SLE and RA for CLN-978, a CD19 T cell engager, to be presented at the EULAR 2026 Congress in June; multi-dose regimen data in RA expected in Q3 2026...OUTRACE SjD: In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data....Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, starting with moderate to severe SLE and to be followed by planned expansion into other indications. Initial multi-dose regimen data from the dose escalation phase in patients with SLE are expected to be shared in Q4 2026."

Enrollment status • P1 data • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus

CLN-978-RA-101: A Phase I, Open-Label Study of CLN-978 in Patients with Treatment-Refractory Rheumatoid Arthritis (RA) (clinicaltrialsregister.eu) - P1 | N=46 | Recruiting | Sponsor: Cullinan Therapeutics Inc.

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

CLN-978-RA-101: A Phase I, Open-Label Study of CLN-978 in Patients with Treatment-Refractory Rheumatoid Arthritis (RA) (clinicaltrialsregister.eu) - P1 | N=46 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | Not yet recruiting ➔ Recruiting

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

CLN-978-SL-101: 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. | N=44 ➔ 24

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

CLN-978-SJ-101: A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogrens Disease (clinicaltrialsregister.eu) - P1 | N=40 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | N=30 ➔ 40

Enrollment change • Sjogren's Syndrome

CLN-978-SL-101: A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | N=24 ➔ 34

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

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

2026 Milestones:…CLN-978 (CD19xCD3 bispecific T cell engager) (GlobeNewswire) - "(i) OUTRACE SLE: In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation)...as well as other biomarker data and preliminary clinical activity data; (ii) OUTRACE RA: In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study...as well as other biomarker data and preliminary clinical activity data. In Q3 2026, the Company plans to share initial repeat dosing data...as well as other biomarker data and preliminary clinical activity data; (iii) OUTRACE SjD: In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation)...as well as other biomarker data and preliminary clinical activity data."

Biomarker • P1 data • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus

CLN-978-SJ-101: A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogrens Disease (clinicaltrialsregister.eu) - P1 | N=30 | Recruiting | Sponsor: Cullinan Therapeutics Inc.

New P1 trial • Sjogren's Syndrome

CLN-978-SL-101: A Phase 1b open label pilot study of CLN-978 for the treatment of moderate to severe systemic lupus erythematosus (SLE) (clinicaltrialsregister.eu) - P1 | N=8 | Not yet recruiting | Sponsor: Cullinan Therapeutics Inc.

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

CLN-978-SL-101: A Phase 1b open label pilot study of CLN-978 for the treatment of moderate to severe systemic lupus erythematosus (SLE) (clinicaltrialsregister.eu) - P1 | N=8 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | Not yet recruiting ➔ Recruiting

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

Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data (The Manila Times) - "In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data; In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data...In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation)....In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data."

P1 data • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus

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