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Cullinan Oncology Inc (CGEM)

(90% Positive) CULLINAN THERAPEUTICS, INC. (CGEM) Announces Enrollment Update for dosing Due to Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Jan. 8, 2026, 12:17 p.m.

    📋 CULLINAN THERAPEUTICS, INC. (CGEM) - Clinical Trial Update

    Filing Date: 2026-01-08

    Accepted: 2026-01-08 07:15:24

    Event Type: Clinical Trial Update

    Event Details:

    Cullinan Oncology Inc (CGEM) Announces Clinical Trial Update Cullinan Oncology Inc (CGEM) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: dosing, engager
    • Diseases/Conditions: autoimmune diseases
    • Clinical Stage: Phase 2
    • Collaboration: Cullinan Therapeutics, Inc.
    • Updated Timeline: Q4 2026 Zipalertinib, December 31, 2025
      • “We have built strong momentum with CLN
      • 978 and are pleased to share that we have completed multiple dose cohorts in our OUTRACE RA and OUTRACE SLE studies, and we have initiated dosing in our Sjögren’s disease study. This significant progress positions us to deliver the first company sponsored data with a CD19 T cell engager in autoimmune diseases. Throughout 2026, we will deliver data across all three indications, including important repeat dosing data in rheumatoid arthritis,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics. “Our CLN
      • 049 program continues to advance following the presentation of compelling efficacy and favorable safety data at ASH 2025, which we believe enables an accelerated approval pathway. We plan to complete dose expansion in relapsed/refractory AML and TP53m AML to rapidly determine a recommended Phase 2 dose, while also initiating a frontline combination study this year. Additionally, 2026 marks a pivotal milestone for zipalertinib, as Taiho completes the rolling NDA submission in the beginning of the year, and completes enrollment in the frontline study REZILIENT3 in the first half of
        • expected in H1 2026
        • planned for CLN-978 across all three autoimmune indications in 2026

    🔬 Clinical Development Pipeline (CULLINAN THERAPEUTICS, INC.):

    Product Type Development Stage Therapeutic Area Source
    CLN-049 DRUG Phase PHASE1 Relapsed/Refractory Acute Myeloid Leukemia (AML) ClinicalTrials.gov
    CLN-978 DRUG Phase PHASE1 SLE ClinicalTrials.gov
    Datopotamab deruxtecan-dlnk (Dato-DXd) DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    pemetrexed DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    Carboplatin AUC 6 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    Paclitaxel DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    Pembrolizumab DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    CLN-619 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Cullinan Oncology Inc
    • CIK: 0001789972
    • Ticker Symbol: CGEM
    • Period End Date: 2026-01-08
    • Document Type: 8-K

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