Cullinan Therapeutics Reports Promising Clinical Data for CLN-978 and Velinotamig
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 10 2026
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Source: Newsfilter
- Significant Clinical Efficacy: CLN-978 demonstrated robust efficacy in the multi-dose RA clinical trial, achieving clinical remission in a poly-refractory patient with a rapid reduction in DAS28-ESR score from 4.0 to 2.2, highlighting its potential in treating refractory RA.
- Favorable Safety Profile: Initial safety data from the multi-dose regimen in SLE patients were consistent with results from RA patients, with no severe adverse events observed, indicating good tolerability and laying a foundation for future clinical applications of CLN-978.
- Remarkable Renal Responses: Velinotamig showed promising clinical activity in refractory SLE patients, with all subjects achieving complete renal responses after four intravenous doses, leading to significant reductions in SLEDAI-2K scores, underscoring its potential in autoimmune diseases.
- Future Development Plans: Cullinan plans to report additional multi-dose data for CLN-978 in RA and SLE in Q3 and Q4 of 2026, respectively, and initiate a clinical trial for autoimmune cytopenias in early 2027, further expanding its clinical application scope.
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About CGEM
Cullinan Therapeutics, Inc. is a biopharmaceutical company. It has built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in autoimmune diseases and cancer. Its portfolio includes a range of modalities. Its pipeline includes CLN-978, CLN-619, Zipalertinib (CLN-081/TAS6417), CLN-049, and CLN-617. CLN-978 is a CD19xCD3 T cell engager being developed for autoimmune diseases. CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by cytotoxic innate and adaptive immune cells. Zipalertinib (CLN-081/TAS6417) is an orally available small-molecule, irreversible epidermal growth factor receptor inhibitor. CLN-049 is a FLT3xCD3 T cell engaging bispecific antibody. CLN-617 is a fusion protein combining two potent antitumor cytokines, interleukin-2 and interleukin-12 with tumor retention domains for the treatment of solid tumors.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cullinan Therapeutics Reports Promising Clinical Data for CLN-978 and Velinotamig
- Significant Clinical Efficacy: CLN-978 demonstrated robust efficacy in the multi-dose RA clinical trial, achieving clinical remission in a poly-refractory patient with a rapid reduction in DAS28-ESR score from 4.0 to 2.2, highlighting its potential in treating refractory RA.
- Favorable Safety Profile: Initial safety data from the multi-dose regimen in SLE patients were consistent with results from RA patients, with no severe adverse events observed, indicating good tolerability and laying a foundation for future clinical applications of CLN-978.
- Remarkable Renal Responses: Velinotamig showed promising clinical activity in refractory SLE patients, with all subjects achieving complete renal responses after four intravenous doses, leading to significant reductions in SLEDAI-2K scores, underscoring its potential in autoimmune diseases.
- Future Development Plans: Cullinan plans to report additional multi-dose data for CLN-978 in RA and SLE in Q3 and Q4 of 2026, respectively, and initiate a clinical trial for autoimmune cytopenias in early 2027, further expanding its clinical application scope.
See More
Cullinan Therapeutics to Host Immunology Day with Key Updates
- Clinical Trial Progress: Cullinan Therapeutics is set to host an Immunology Day on June 10, 2026, where updates on CLN-978 and Velinotamig will be shared, likely attracting investor interest in its innovations within the autoimmune disease sector.
- CLN-978 Studies: CLN-978, a CD19-targeting bispecific T cell engager, is undergoing three global phase 1 studies, with preliminary data indicating significant clinical benefits in systemic lupus erythematosus and rheumatoid arthritis patients, potentially driving further treatment development.
- Velinotamig Development: The company licensed global rights to Velinotamig in 2025, currently conducting a phase 1 study for moderate to severe systemic lupus erythematosus, which may provide new treatment options for autoimmune diseases and expand its product pipeline.
- Strong Financial Position: As of March 31, 2026, Cullinan reported $393 million in cash and investments, expected to fund operations through 2029, demonstrating a robust financial foundation for ongoing R&D and market expansion.
See More
CLN-978 Shows Significant Clinical Benefits in Autoimmune Diseases
- Significant Clinical Benefits: CLN-978 demonstrated clinical benefits, including remissions in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), indicating its potential as a treatment for multiple challenging autoimmune diseases.
- B Cell Depletion Effects: The study revealed dose-dependent B cell depletion with CLN-978, with 82% of 14 SLE patients achieving over 80% reduction in B cell counts from baseline, providing strong evidence for its role as a disease-modifying treatment.
- Favorable Safety Profile: CLN-978 was well tolerated across 10µg, 20µg, and 30µg dose cohorts, with most cytokine release syndrome (CRS) events being Grade 1, suggesting its potential for use in outpatient community care settings.
- Multi-Dose Regimen Research: As multi-dose regimen studies progress, Cullinan plans to share initial data from the RA multi-dose cohort on June 10 during Immunology Day, further advancing the global clinical development of CLN-978.
See More
Cullinan Receives FDA Orphan Drug Designation
- Orphan Drug Designation: Cullinan Therapeutics' CLN-049 has received Orphan Drug Designation from the FDA, providing development incentives such as tax credits and market exclusivity for its acute myeloid leukemia treatment.
- Clinical Trial Incentives: This designation allows CLN-049 to benefit from tax credits for qualified clinical trials and exemptions from certain FDA user fees, thereby reducing R&D costs and accelerating the path to market.
- Innovative Treatment Approach: CLN-049 is a novel FLT3xCD3 T cell engager designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic strategy for treating acute myeloid leukemia and myelodysplastic syndrome.
- Positive Market Reaction: Following the designation, Cullinan's shares rose over 2% in pre-market trading, indicating a positive market sentiment regarding the drug's development prospects and reflecting investor confidence in the company's future growth potential.
See More
CLN-049 Receives FDA Orphan Drug Designation
- FDA Orphan Drug Designation: CLN-049 has received Orphan Drug Designation from the FDA, highlighting the urgent need for therapies for relapsed/refractory acute myeloid leukemia (AML) patients, particularly those with TP53 mutations, indicating significant market potential.
- Clinical Trial Progress: The ongoing Phase 1 clinical trial of CLN-049 demonstrates promising safety and tolerability, which is expected to provide new treatment options for AML patients, potentially improving survival rates and quality of life.
- Market Exclusivity Advantage: With Orphan Drug Designation, CLN-049 will benefit from seven years of market exclusivity, presenting Cullinan Therapeutics with substantial commercial opportunities to establish a leading position in a competitive market.
- Innovative Treatment Approach: As a novel FLT3xCD3 T cell engager, CLN-049 targets FLT3-expressing leukemia cells, offering a new immunotherapeutic strategy that could transform the treatment landscape for AML.
See More
Cullinan Therapeutics Presents Initial Clinical Data for CLN-978 at EULAR Congress
- Clinical Data Presentation: Cullinan Therapeutics will present initial clinical data for CLN-978 at the EULAR Congress from June 3-6, 2026, showcasing findings from two Phase 1 studies focused on rheumatoid arthritis and systemic lupus erythematosus, indicating a favorable safety profile and early clinical activity signals.
- Targeted Treatment Effects: Initial dose levels of CLN-978 demonstrate significant B cell depletion, with early clinical activity signals observed in patients with rheumatoid arthritis and systemic lupus erythematosus, potentially offering new hope for treating these refractory diseases.
- Global Study Recruitment: The OUTRACE RA and OUTRACE SLE studies are actively recruiting patients globally, with the former targeting rheumatoid arthritis patients who have undergone multiple targeted treatments, and the latter focusing on systemic lupus erythematosus patients previously treated with biologics or immunosuppressants, reflecting the company's proactive clinical research strategy.
- Innovative Drug Potential: CLN-978, as a novel bispecific T cell engager with high affinity and small molecular size, aims to provide a convenient subcutaneous administration option for patients with rheumatoid arthritis and systemic lupus erythematosus, potentially transforming existing treatment paradigms and enhancing patient quality of life.
See More
Cullinan Therapeutics Reports Promising Clinical Data for CLN-978 and Velinotamig
- Significant Clinical Efficacy: CLN-978 demonstrated robust efficacy in the multi-dose RA clinical trial, achieving clinical remission in a poly-refractory patient with a rapid reduction in DAS28-ESR score from 4.0 to 2.2, highlighting its potential in treating refractory RA.
- Favorable Safety Profile: Initial safety data from the multi-dose regimen in SLE patients were consistent with results from RA patients, with no severe adverse events observed, indicating good tolerability and laying a foundation for future clinical applications of CLN-978.
- Remarkable Renal Responses: Velinotamig showed promising clinical activity in refractory SLE patients, with all subjects achieving complete renal responses after four intravenous doses, leading to significant reductions in SLEDAI-2K scores, underscoring its potential in autoimmune diseases.
- Future Development Plans: Cullinan plans to report additional multi-dose data for CLN-978 in RA and SLE in Q3 and Q4 of 2026, respectively, and initiate a clinical trial for autoimmune cytopenias in early 2027, further expanding its clinical application scope.
See More
Cullinan Therapeutics to Host Immunology Day with Key Updates
- Clinical Trial Progress: Cullinan Therapeutics is set to host an Immunology Day on June 10, 2026, where updates on CLN-978 and Velinotamig will be shared, likely attracting investor interest in its innovations within the autoimmune disease sector.
- CLN-978 Studies: CLN-978, a CD19-targeting bispecific T cell engager, is undergoing three global phase 1 studies, with preliminary data indicating significant clinical benefits in systemic lupus erythematosus and rheumatoid arthritis patients, potentially driving further treatment development.
- Velinotamig Development: The company licensed global rights to Velinotamig in 2025, currently conducting a phase 1 study for moderate to severe systemic lupus erythematosus, which may provide new treatment options for autoimmune diseases and expand its product pipeline.
- Strong Financial Position: As of March 31, 2026, Cullinan reported $393 million in cash and investments, expected to fund operations through 2029, demonstrating a robust financial foundation for ongoing R&D and market expansion.
See More
CLN-978 Shows Significant Clinical Benefits in Autoimmune Diseases
- Significant Clinical Benefits: CLN-978 demonstrated clinical benefits, including remissions in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), indicating its potential as a treatment for multiple challenging autoimmune diseases.
- B Cell Depletion Effects: The study revealed dose-dependent B cell depletion with CLN-978, with 82% of 14 SLE patients achieving over 80% reduction in B cell counts from baseline, providing strong evidence for its role as a disease-modifying treatment.
- Favorable Safety Profile: CLN-978 was well tolerated across 10µg, 20µg, and 30µg dose cohorts, with most cytokine release syndrome (CRS) events being Grade 1, suggesting its potential for use in outpatient community care settings.
- Multi-Dose Regimen Research: As multi-dose regimen studies progress, Cullinan plans to share initial data from the RA multi-dose cohort on June 10 during Immunology Day, further advancing the global clinical development of CLN-978.
See More
Cullinan Receives FDA Orphan Drug Designation
- Orphan Drug Designation: Cullinan Therapeutics' CLN-049 has received Orphan Drug Designation from the FDA, providing development incentives such as tax credits and market exclusivity for its acute myeloid leukemia treatment.
- Clinical Trial Incentives: This designation allows CLN-049 to benefit from tax credits for qualified clinical trials and exemptions from certain FDA user fees, thereby reducing R&D costs and accelerating the path to market.
- Innovative Treatment Approach: CLN-049 is a novel FLT3xCD3 T cell engager designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic strategy for treating acute myeloid leukemia and myelodysplastic syndrome.
- Positive Market Reaction: Following the designation, Cullinan's shares rose over 2% in pre-market trading, indicating a positive market sentiment regarding the drug's development prospects and reflecting investor confidence in the company's future growth potential.
See More
CLN-049 Receives FDA Orphan Drug Designation
- FDA Orphan Drug Designation: CLN-049 has received Orphan Drug Designation from the FDA, highlighting the urgent need for therapies for relapsed/refractory acute myeloid leukemia (AML) patients, particularly those with TP53 mutations, indicating significant market potential.
- Clinical Trial Progress: The ongoing Phase 1 clinical trial of CLN-049 demonstrates promising safety and tolerability, which is expected to provide new treatment options for AML patients, potentially improving survival rates and quality of life.
- Market Exclusivity Advantage: With Orphan Drug Designation, CLN-049 will benefit from seven years of market exclusivity, presenting Cullinan Therapeutics with substantial commercial opportunities to establish a leading position in a competitive market.
- Innovative Treatment Approach: As a novel FLT3xCD3 T cell engager, CLN-049 targets FLT3-expressing leukemia cells, offering a new immunotherapeutic strategy that could transform the treatment landscape for AML.
See More
Cullinan Therapeutics Presents Initial Clinical Data for CLN-978 at EULAR Congress
- Clinical Data Presentation: Cullinan Therapeutics will present initial clinical data for CLN-978 at the EULAR Congress from June 3-6, 2026, showcasing findings from two Phase 1 studies focused on rheumatoid arthritis and systemic lupus erythematosus, indicating a favorable safety profile and early clinical activity signals.
- Targeted Treatment Effects: Initial dose levels of CLN-978 demonstrate significant B cell depletion, with early clinical activity signals observed in patients with rheumatoid arthritis and systemic lupus erythematosus, potentially offering new hope for treating these refractory diseases.
- Global Study Recruitment: The OUTRACE RA and OUTRACE SLE studies are actively recruiting patients globally, with the former targeting rheumatoid arthritis patients who have undergone multiple targeted treatments, and the latter focusing on systemic lupus erythematosus patients previously treated with biologics or immunosuppressants, reflecting the company's proactive clinical research strategy.
- Innovative Drug Potential: CLN-978, as a novel bispecific T cell engager with high affinity and small molecular size, aims to provide a convenient subcutaneous administration option for patients with rheumatoid arthritis and systemic lupus erythematosus, potentially transforming existing treatment paradigms and enhancing patient quality of life.
See More
