Drugs / CLN-978
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07041099 | Oct 2025 → Mar 2028 expected | Sjogren syndrome | Cullinan Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06994143 | May 2025 → Dec 2027 expected | rheumatoid arthritis | Cullinan Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06613360 | Jan 2025 → Dec 2026 expected | systemic lupus erythematosus | Cullinan Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05879744 | May 2023 → Nov 2026 expected | non-Hodgkin lymphoma | Cullinan Therapeutics Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-06-10 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune Diseases cullinantherapeutics.com ↗
CLN-978 data from the first RA multi-dose regimen cohort demonstrated robust efficacy, including clinical remission in a poly-refractory patient, with a favorable safety profile |
| 2026-06-06 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 Congress cullinantherapeutics.com ↗
Following a single target dose of CLN-978, patients with refractory SLE and difficult-to-treat RA demonstrated clinical benefit, including remissions. |
| 2026-05-18 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress cullinantherapeutics.com ↗
The abstract reports that single target doses of CLN-978 demonstrate a favorable safety profile at the initial dose levels. |
| 2025-10-25 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics Shares Additional Preclinical B Cell Depletion Data for CLN-978, Supporting Clinical Development Across Multiple Autoimmune Diseases, at ACR Convergence 2025 cullinantherapeutics.com ↗
CLN-978 led to rapid and deep B cell depletion in vitro and in vivo in multiple autoimmune diseases |
| 2025-05-08 | Cullinan Therapeutics Inc. | Regulatory Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results cullinantherapeutics.com ↗
Company received approval from European Medicines Agency (EMA) for CLN-978; |
| 2025-04-16 | Cullinan Therapeutics Inc. | Regulatory 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 cullinantherapeutics.com ↗
Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the European Medicines Agency (EMA) approved the Company’s Clinical Trial Application (CTA) for CLN-978. |
| 2024-11-14 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics Announces Preclinical Data for CLN-978, a CD19-directed T Cell Engager, to be Presented at ACR Convergence 2024 cullinantherapeutics.com ↗
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). |
| 2024-11-07 | Cullinan Therapeutics Inc. | Regulatory Cullinan Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results cullinantherapeutics.com ↗
We have secured clearance from the U.S. Food and Drug Administration (FDA) for our IND application and Human Research Ethics Committee (HREC) approval in Australia to initiate our global Phase 1 study for CLN-978 in moderate to severe SLE. |
| 2024-11-04 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics to Present Preclinical Data for CLN-978, a CD19-directed T Cell Engager, at ACR Convergence 2024 cullinantherapeutics.com ↗ |
| 2024-10-16 | Cullinan Therapeutics Inc. | Regulatory 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 cullinantherapeutics.com ↗ |
| 2024-09-17 | Cullinan Therapeutics Inc. | Regulatory Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial of CLN-978 for the Treatment of Systemic Lupus Erythematosus cullinantherapeutics.com ↗
today 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). |
| 2024-09-16 | Cullinan Therapeutics Inc. | Regulatory Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus cullinantherapeutics.com ↗
today 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). |
| 2024-04-16 | Cullinan Therapeutics Inc. | Results Cullinan Therapeutics Announces Strategic Expansion into Autoimmune Diseases cullinantherapeutics.com ↗
Clinical observations from CLN-978 B-NHL study show rapid, deep, and sustained B cell depletion and clinical activity |
| 2023-11-03 | Cullinan Therapeutics Inc. | Results Cullinan Oncology to Present Data Demonstrating Progress Across Its Broad Immunotherapy-Pipeline at SITC 2023 cullinantherapeutics.com ↗
CLN-978, a novel CD19/CD3/HSA T cell engager with extended serum half-life, is effective against lymphoma cells expressing very low levels of CD19 |
| 2023-01-24 | Cullinan Therapeutics Inc. | Regulatory Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for CLN-978, a Novel T-Cell Engager for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma cullinantherapeutics.com ↗ |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CLN-978 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06613360 ↗ |
| Modality | Other / unclassified | “CD19-directed T Cell Engager” NCT06994143 ↗ |
| Route | Subcutaneous | “Subcutaneously Administered” NCT06613360 ↗ |
| Target | CD19 | “CD19-directed T Cell Engager” NCT06613360 ↗ |