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Cullinan Therapeutics, Inc.

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  • CLN-978CLN-978 / CD19xCD3 / bispecific T cell engager / Immunology
    OUTRACE: Rheumatoid arthritisPhase 1Initial data in RA in Q2 2026 and repeat dosing data in Q3 2026EuropeOUTRACE: Systemic lupus erythematosusPhase 1bInitial data in SLE in Q2 2026GlobalOUTRACE: Sjögren’s diseasePhase 1Initial data in Sjögren’s disease in Q4 2026Global
  • VelinotamigBCMAxCD3 / bispecific T cell engager / Immunology
    Autoimmune diseasesIND-EnablingGenrix Bio initiated a Phase 1 study in China in Q4 2025; initial data expected in Q4 2026; clinical trial status not yet recruitingChina
  • ZipalertinibEGFR ex20ins / tyrosine kinase inhibitor (TKI) / Oncology
    REZILIENT1: Non-small cell lung cancerPhase 2U.S. FDA accepted NDA for relapsed EGFR ex20ins NSCLC; PDUFA target action date February 27, 2027United StatesREZILIENT2: Non-small cell lung cancerPhase 2Parallel cohort study ongoingREZILIENT3: Non-small cell lung cancerPhase 3Phase 3 1L study fully enrolled; Taiho expects topline results by end of 2026Global
  • CLN-049CLN-049 / FLT3xCD3 / bispecific T cell engager / Oncology
    Acute myeloid leukemia and myelodysplastic syndromePhase 1Dose escalation update in H2 2026; dose expansion cohorts to initiate in Q2 2026 and complete enrollment in Q4 2026Measurable residual disease in acute myeloid leukemiaPhase 1Phase 1 study ongoing

Latest news12 items

All news

Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer

Presentation will feature results from the planned interim analysis of the Phase 3 REZILIENT3 trial, which met its primary endpoint of progression-free survival in first line EGFR exon 20 insertion mutation NSCLC PRINCETON, N.J., CAMBRIDGE, Mass., August 19, 2026 — Taiho Oncology, Inc.

Presentation / Abstract • Phase 3Presidential Symposium presentation Mon, Sep 14, 2026, 8:00 AM KST

Zipalertinib Plus Chemotherapy Meets Primary Endpoint of Progression-Free Survival in Planned Interim Analysis of Phase 3 REZILIENT3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer

PRINCETON, New Jersey, TOKYO, Japan, CAMBRIDGE, Mass., August 12, 2026 — Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib and

Trial Results • Phase 3REZILIENT3 interim analysis results Wed, Aug 12, 2026

Cullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune Diseases

CLN-978 (CD19 TCE) EULAR data demonstrated potential for immune reset, including remissions, in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) CLN-978 data from the first RA multi-dose regimen cohort demonstrated robust efficacy, including clinical remission in a

Presentation / Abstract • Phase 1EULAR 2026 Congress presentation Wed, Jun 10, 2026

Cullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 Congress

Clinical benefit, including remissions, demonstrated in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients following a single target dose of CLN-978 Deep, dose-dependent B cell depletion observed in peripheral blood and tissue Favorable safety profile with single target

Presentation / Abstract • Phase 1Poster presentation Sat, Jun 6, 2026, 10:15 AM BST

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

New and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies Initial data from the first multi-dose cohort of RA study to be presented Initial data from the first multi-dose cohort of velinotamig study also to

Results CallResults call Wed, Jun 10, 2026, 8:30 AM ET

Cullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress

CAMBRIDGE, Mass., May 18, 2026 (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, today announced that initial clinical data from two

Presentation / Abstract • Phase 1Poster presentation Sat, Jun 6, 2026, 10:15 AM BST

U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

NDA submission based on the Phase 2b REZILIENT1 clinical trial, which demonstrated clinically meaningful and durable responses in patients with relapsed EGFR exon 20 insertion–mutated NSCLC Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027 PRINCETON, New Jersey, TOKYO,

Cullinan Therapeutics, Inc. • Endpoint Arena