Cullinan Therapeutics reports remissions in SLE, RA with CLN-978
Cullinan Therapeutics announced new clinical data for its T cell engager portfolio, highlighting remissions in SLE and RA with CLN-978 and complete renal responses with velinotamig. The data supports the development of differentiated CD19 and BCMA T cell engagers for autoimmune diseases.
*this image is generated using AI for illustrative purposes only.
Cullinan Therapeutics, Inc. announced new clinical data for its T cell engager portfolio, highlighting remissions in systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) with CLN-978, and complete renal responses with velinotamig. The data, presented at the EULAR 2026 Congress and during an Immunology Day event on June 10, demonstrated the potential for immune reset and durable treatment-free remissions. Nadim Ahmed, President and Chief Executive Officer of Cullinan Therapeutics, stated that the data support the strategy to develop differentiated CD19 and BCMA T cell engagers to address B cell– and plasma cell–driven autoimmune diseases.
CLN-978 (CD19xCD3 T cell engager)
CLN-978 showed robust efficacy in the Phase 1 OUTRACE RA and SLE clinical trials. In the RA trial, a patient refractory to prior rituximab achieved DAS28-ESR remission, with a baseline score of 4.0 reducing to 2.2 at week 4 and maintained through week 8. In the SLE trial, 10 of 14 patients achieved a ≥4-point reduction in hSLEDAI (71%), with 5 reaching DORIS remission. Peripheral B cell depletion below the limit of quantification (BLOQ) was achieved in 50% of SLE patients treated at doses ≥20 µg.
The table summarizes the patient distribution across cohorts for SLE and RA as of May 15, 2026.
| Dose levels investigated | SLE (Safety) | SLE (PD) | SLE (Efficacy) | RA (Safety) | RA (PD) | RA (Efficacy) |
|---|---|---|---|---|---|---|
| Cohort 1 (D1: 10 µg) | 3 | 3 | 3 | 1 | 1 | 1 |
| Cohort 2 (D1: 10 µg, D8: 20 µg) | 7 | 7 | 4 | 3 | 3 | 3 |
| Cohort 3 (D1: 10 µg, D8: 30 µg) | 7 | 6 | 6 | 3 | 3 | 3 |
| Cohort 4 (D1: 10 µg, D8: 45 µg) | 1 | 1 | 1 | - | - | - |
| Cohort 5 (D1: 10 µg, D8/15/22: 20 µg) | - | - | - | 4 | - | - |
| Total patients | 18 | 17 | 14 | 11 | 7 | 7 |
PD=pharmacodynamics.
Safety Profile
CLN-978 was well tolerated across the 10 µg, 20 µg, and 30 µg cohorts. Most cytokine release syndrome (CRS) events were Grade 1. A single Grade 3 CRS event occurred at the 45 µg dose, leading to discontinuation of enrollment in that cohort. No immune effector cell–associated neurotoxicity syndrome (ICANS) was observed.
Velinotamig (BCMAxCD3 T cell engager)
Initial data for velinotamig demonstrated promising clinical activity in refractory SLE. Two patients treated with four intravenous doses achieved complete renal response, with SLEDAI-2K scores dropping from 16 and 14 at baseline to 0 and 2 at week 8, respectively. Velinotamig showed a favorable safety profile with no CRS or ICANS observed. Cullinan plans to initiate a Phase 1/2a clinical trial in Q1 2027 for autoimmune cytopenias, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA).
What are the anticipated timelines for advancing CLN-978 into Phase 2 trials following the positive Phase 1 safety and efficacy data?
How will Cullinan address the safety concerns observed at the 45 µg dose level to determine the maximum tolerated dose for future studies?
What competitive advantages does CLN-978 offer over existing CD19 therapies in achieving durable, treatment-free remissions for RA and SLE patients?
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