Cullinan Therapeutics Shares Additional Preclinical B Cell Depletion Data for CLN-978, Supporting Clinical Development Across Multiple Autoimmune Diseases, at ACR Convergence 2025
Cullinan Therapeutics (Nasdaq: CGEM) will present new preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at ACR Convergence 2025 (poster session Oct 28, Poster 2293; Booth #1074).
Preclinical results showed rapid, dose-dependent B cell depletion in human PBMCs from RA, Sjögren's, and SLE patients and in nonhuman primates after subcutaneous dosing, with sustained depletion in blood, bone marrow, and lymph nodes. In an SLE mouse model, CLN-978 reduced circulating B cells, anti-dsDNA IgG, and kidney IgG deposition. The company is advancing OUTRACE clinical programs in RA (NCT06994143), SjD (NCT07041099), and SLE (NCT06613360).
Cullinan Therapeutics (Nasdaq: CGEM) presenterà nuovi dati preclinici per CLN-978, una bispecific CD19xCD3 T cell engager, a ACR Convergence 2025 (sessione poster, 28 ottobre, Poster 2293; Stand n. 1074).
I risultati preclinici hanno mostrato una rapida deplezione delle cellule B in PBMC umani provenienti da pazienti con artrite reumatoide (AR), sindrome di Sjögren e LES e nei primati non umani dopo somministrazione sottocutanea, con deplezione sostenuta nel sangue, nel midollo osseo e nei linfonodi. In un modello murino di LES, CLN-978 ha ridotto le cellule B circolanti, gli IgG anti-dsDNA e il deposito di IgG nei reni. L’azienda sta avanzando i programmi clinici OUTRACE in AR (NCT06994143), SjD (NCT07041099) e LES (NCT06613360).
Cullinan Therapeutics (Nasdaq: CGEM) presentará nuevos datos preclínicos de CLN-978, un iniciador biespecífico CD19xCD3 de células T, en ACR Convergence 2025 (sesión de póster el 28 de octubre, Póster 2293; Stand #1074).
Los resultados preclínicos mostraron una rápida depleción de células B en PBMC humanas de pacientes con AR, Sjögren y LES y en primates no humanos tras dosis subcutánea, con depleción sostenida en sangre, médula ósea y ganglios linfáticos. En un modelo de ratón de LES, CLN-978 redujo las células B circulantes, IgG anti-dsDNA e depósito de IgG en los riñones. La compañía está avanzando los programas clínicos OUTRACE en AR (NCT06994143), SjD (NCT07041099) y LES (NCT06613360).
Cullinan Therapeutics (Nasdaq: CGEM)은 CLN-978의 새로운 전임상 데이터를 ACR Convergence 2025에서 발표할 예정입니다. CLN-978은 CD19xCD3 이중 특이적 T 세포 작용제이며, 포스터 세션은 10월 28일; 포스터 2293; 부스 #1074.
전임상 결과는 RA, 쇼그렌 증후군, SLE 환자들의 인간 PBMC 및 비인간 영장류에서 피하 투여 후 용량 의존적으로 B 세포를 빠르게 고갈시키고, 혈액, 골수, 림프절에서 지속적인 고갈을 보였습니다. SLE 마우스 모델에서 CLN-978은 순환 B 세포, 항-dsDNA IgG, 신장 IgG 침착을 감소시켰습니다. 회사는 RA(NCT06994143), SjD(NCT07041099), SLE(NCT06613360)에서 OUTRACE 임상 프로그램을 진행 중입니다.
Cullinan Therapeutics (Nasdaq : CGEM) présentera de nouveaux donnees précliniques pour CLN-978, un engégateur T cellulaire bispécifique CD19xCD3, lors de ACR Convergence 2025 (session poster le 28 octobre, Poster 2293 ; Stand n°1074).
Les résultats précliniques ont montré une déplétion rapide et dépendante de la dose des lymphocytes B dans les PBMC humains issus de patients atteints de PR, de syndrome de Sjögren et de LES et chez les primates non humains après administration sous-cutanée, avec une déplétion soutenue dans le sang, la moelle osseuse et les ganglions lymphatiques. Dans un modèle murin de LES, CLN-978 a réduit les cellules B circulantes, les IgG anti-dsDNA et le dépôt d’IgG dans les reins. L’entreprise fait progresser les programmes cliniques OUTRACE dans le PR (NCT06994143), SjD (NCT07041099) et LES (NCT06613360).
Cullinan Therapeutics (Nasdaq: CGEM) wird neue präklinische Daten zu CLN-978, einem CD19xCD3-Bispektral-T-Zell-Gateway, auf der ACR Convergence 2025 vorstellen (Poster-Sitzung 28. Oktober, Poster 2293; Stand #1074).
Präklinische Ergebnisse zeigten eine schnelle, dosisabhängige Depletion von B-Zellen in menschlichen PBMCs von RA-, Sjögren- und SLE-Patienten sowie bei nichtmenschlichen Primaten nach subkutaner Verabreichung, mit anhaltender Depletion im Blut, Knochenmark und in Lymphknoten. In einem SLE-Mausmodell reduzierte CLN-978 zirkulierende B-Zellen, anti-dsDNA-IgG und IgG-Ablagerungen in der Niere. Das Unternehmen treibt OUTRACE-klinische Programme in RA (NCT06994143), SjD (NCT07041099) und SLE (NCT06613360) voran.
Cullinan Therapeutics (Nasdaq: CGEM) ستقدم بيانات جديدة قبل السريرية لـ CLN-978، وهو مُنَظِّم خلايا T ثنائي التخصيص CD19xCD3، في ACR Convergence 2025 (جلسة الملخصات Poster يوم 28 أكتوبر، Poster 2293؛ المعرض #1074).
أظهرت النتائج قبل السريرية انخفاضاً سريعاً يعتمد على الجرعة لخلايا B في PBMC البشرية من مرضى RA وSjögren وSLE وفي الرئيسيات غير البشرية بعد إعطاء تحت جلدي، مع انخفاض مستمر في الدم ونخاع العظم والغُدَيات اللمفاوية. وفي نموذج فئران LES، خفض CLN-978 الخلايا B الدائرة، IgG مضاد-dsDNA، وترسب IgG في الكلى. تواصل الشركة برامج OUTRACE السريرية في RA (NCT06994143)، SjD (NCT07041099)، وLES (NCT06613360).
Cullinan Therapeutics (纳斯达克股票代码 CGEM) 将在 ACR Convergence 2025 上展示 CLN-978 的新的前临床数据，CLN-978 是 CD19xCD3 双靶向 T 细胞连接子，展会日程为 10 月 28 日的海报环节；海报编号为 2293；展台 #1074。
前临床结果显示，在来自类风湿关节炎（RA）、干燥综合征（Sjögren）和系统性红斑狼疮（SLE）患者的人类 PBMCs 及非人灵长类动物中，经皮下给药后，B 细胞迅速且呈剂量依赖性耗竭，且血液、骨髓和淋巴结中的耗竭持续存在。在一个 SLE 小鼠模型中，CLN-978 减少循环的 B 细胞、抗 dsDNA IgG 以及肾脏 IgG 的沉积。公司正在推进 OUTRACE 项目在 RA（NCT06994143）、SjD（NCT07041099）和 SLE（NCT06613360）中的临床计划。
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Insights
Preclinical data show strong B cell depletion and disease markers improvement, supporting ongoing clinical programs.
CLN-978, a CD19xCD3 bispecific T cell engager, produced robust, target‑specific B cell depletion and T cell activation in human PBMCs from patients with rheumatoid arthritis, Sjögren’s disease, and systemic lupus erythematosus, matching effects seen in healthy donor cells. Dose‑dependent, deep, and sustained B cell depletion occurred after subcutaneous dosing in nonhuman primates, including in blood, bone marrow, and lymph nodes, at doses described as well tolerated.
In a murine SLE model, treatment reduced circulating B cells, anti-dsDNA IgG, and IgG kidney deposition, signaling a measurable effect on disease biology rather than symptom relief alone. These findings align with the company’s advancement of global clinical OUTRACE studies (NCT06994143, NCT07041099, NCT06613360) and justify continued clinical evaluation.
Key dependencies and risks include whether NHP tolerability and tissue depletion translate to humans and whether reductions in preclinical disease markers will produce meaningful clinical benefit and safety in patients. Watch for initial clinical pharmacodynamics, safety readouts, and any announced patient-level B cell depletion or biomarker changes from ongoing trials within the next 6-18 months, and for the poster presentation on
CLN-978 led to rapid and deep B cell depletion in vitro and in vivo in multiple autoimmune diseases
CAMBRIDGE, Mass., Oct. 25, 2025 (GLOBE NEWSWIRE) -- 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, will present new preclinical data for CLN-978, its novel investigational CD19xCD3 bispecific T cell engager. These data will be presented at the American College of Rheumatology (ACR) Convergence 2025, being held in Chicago, Illinois, October 24-29, in a poster presentation session on October 28, 10:30 a.m.-12:30 p.m. CT (Poster Session C, Poster Number 2293). Cullinan will also have a Booth (#1074) in the Exhibit Hall.
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). These effects were similar to those observed with PBMCs from healthy donors.
Dose-dependent B cell depletion was observed following subcutaneous administration of CLN-978 in nonhuman primates (NHPs). Doses of CLN-978 considered well tolerated in the NHPs achieved deep and sustained B cell depletion in blood and multiple tissues including bone marrow and lymph nodes, suggesting the potential to achieve meaningful B cell depletion in patients.
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.
“We continue to generate preclinical data that reinforce the potential of CLN-978 as a highly potent T cell engager designed to deplete B cells deeply across multiple autoimmune diseases,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “In parallel, we are advancing our global clinical programs in rheumatoid arthritis, Sjögren’s disease, and systemic lupus erythematosus, recognizing the significant unmet needs for people living with these diseases. Current therapies are typically limited to addressing disease symptoms whereas CLN-978 has the potential to modify the underlying pathophysiology of the disease itself.”
Cullinan is advancing the global clinical development of CLN-978 through its OUTRACE studies across RA (NCT06994143), SjD (NCT07041099), and SLE (NCT06613360), with active trials now underway across all three indications and in multiple countries.
About CLN-978
CLN-978 is a novel, differentiated and highly potent CD19xCD3 bispecific T cell engager. CLN-978 triggers redirected lysis of CD19-expressing target cells in vitro and in vivo. CLN-978 is engineered to achieve very high affinity binding to CD19 to efficiently target B cells, including those with very low CD19 levels. Small in molecular size (65 kDa), CLN-978 contains two single-chain variable fragments, one binding with very high affinity to the CD19 target and the other binding to CD3 on T cells, and a single-domain antibody binding to human serum albumin to extend serum half-life. CLN-978 was developed by an internal Cullinan team and is a wholly owned asset. CLN-978 has the potential to offer a convenient, off-the-shelf, subcutaneously delivered therapeutic option for patients living with autoimmune diseases and is being studied in Cullinan’s OUTRACE studies for patients with rheumatoid arthritis, Sjögren’s disease, and systemic lupus erythematosus. CLN-978 is investigational and has not been approved by any health authority.
About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: future data presentations, our preclinical and clinical developments plans and timelines for CLN-978, the clinical and therapeutic potential of CLN-978, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.
Contacts:
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Nick Smith
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Nsmith@cullinantx.com
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FAQ
When and where will Cullinan Therapeutics present CLN-978 data at ACR Convergence 2025 (CGEM)?
What preclinical effects of CLN-978 did Cullinan report for autoimmune diseases (CGEM)?
How is Cullinan advancing CLN-978 into clinical trials (CGEM)?
What route of administration showed B cell depletion for CLN-978 in nonhuman primates (CGEM)?
Does Cullinan report CLN-978 activity in patient-derived immune cells from different autoimmune diseases (CGEM)?
