This section highlights FDA-related milestones and regulatory updates for drugs developed by Cullinan Therapeutics (CGEM).
Over the past two years, Cullinan Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CLN-978 and zipalertinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CLN-978 - FDA Regulatory Timeline and Events
CLN-978 is a drug developed by Cullinan Therapeutics for the following indication: To Treat Systemic Lupus Erythematosus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CLN-978
- Announced Date:
- May 8, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics announced that it received approval from European Medicines Agency (EMA) for CLN-978
AI Summary
Cullinan Therapeutics announced that it has received approval from the European Medicines Agency (EMA) to begin a Phase 1 trial of its T cell engager, CLN-978, for patients with active, difficult-to-treat rheumatoid arthritis. The study is set to start in Q2 2025 at major trial centers in Germany and Italy, marking an important step in developing targeted therapies for autoimmune diseases.
This EMA approval supports Cullinan’s commitment to advance treatment options in the autoimmune field. The company is also progressing its studies of CLN-978 in patients with systemic lupus erythematosus and Sjögren’s disease, with additional data anticipated later this year or early next year. The initiative reinforces Cullinan's role in pioneering innovative medicines to address challenging autoimmune conditions.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- April 29, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, announced that the Company is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) in the U.S.
AI Summary
Cullinan Therapeutics has announced the start of a U.S. study to evaluate its novel therapeutic, CLN-978, in patients with moderate to severe Sjögren’s disease. This study will enroll patients who meet the 2016 ACR/EULAR classification criteria and test positive for anti-SSA/RO antibodies or rheumatoid factor. The trial will use a dose escalation scheme similar to previous studies, with the primary goal of assessing the safety and tolerability of CLN-978 in this patient group. Additionally, researchers will explore secondary outcomes such as pharmacokinetics, pharmacodynamics, immunogenicity, and CLN-978’s overall effect on disease activity. This new study is designed to address the significant unmet needs of individuals living with Sjögren’s disease, a condition marked by chronic pain, fatigue, and other systemic complications, potentially offering a new, convenient subcutaneous treatment option.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- April 16, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, announced that Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025
AI Summary
Cullinan Therapeutics announced that a company-sponsored clinical trial will begin in the second quarter of 2025 at two leading European research centers: FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Rome, Italy. The trial will study CLN-978, a novel CD19-targeting bispecific T cell engager, and aims to evaluate its safety, dosing, and overall effectiveness in treating autoimmune diseases.
This initiative is part of a broader global clinical development plan, with additional studies already underway in the U.S., Europe, and Australia focusing on systemic lupus erythematosus. The research aims to address the significant treatment gap for patients with difficult-to-treat autoimmune conditions by offering a potentially more accessible, off-the-shelf subcutaneous therapy that could improve disease management and patient quality of life.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- April 16, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, announced that the European Medicines Agency (EMA) approved the Company's Clinical Trial Application (CTA) for CLN-978.
AI Summary
Cullinan Therapeutics recently reached a significant milestone when the European Medicines Agency (EMA) approved its Clinical Trial Application (CTA) for CLN-978. This clearance allows the company to begin a Phase 1 open-label clinical trial in the second quarter of 2025 in two European centers: FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Rome. The trial will focus on patients with active, treatment-resistant rheumatoid arthritis, assessing safety, pharmacokinetics, pharmacodynamics, and the drug’s effects on disease activity.
CLN-978 is a novel, CD19-targeting T cell engager that offers potential benefits in managing autoimmune conditions, including rheumatoid arthritis and systemic lupus erythematosus. This regulatory step is a key part of Cullinan’s global development plan, which aims to provide convenient, off-the-shelf, subcutaneous treatments that could improve therapy flexibility and outcomes for patients in need of better treatment options.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- February 27, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, reported recent and anticipated business highlights
AI Summary
Cullinan Therapeutics reported recent and upcoming milestones that underscore its leadership in targeted therapies. The company highlighted CLN-978 as the first and only development-stage CD19 T cell engager with FDA IND clearance for autoimmune diseases in the U.S. Initial clinical data from the global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) is expected by the fourth quarter of 2025, and a Phase 1 study in rheumatoid arthritis is set to launch in the second quarter of 2025. Additionally, the pivotal Phase 2b portion of the REZILIENT1 study for zipalertinib, an EGFR exon20 insertion inhibitor, met its primary endpoint, boosting optimism for its use in NSCLC patients. Full results for zipalertinib are anticipated by mid-2025, with an NDA submission planned for the second half of 2025 after further discussions with the FDA.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- September 17, 2024
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, Inc 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)..
AI Summary
Cullinan Therapeutics has received Human Research Ethics Committee (HREC) approval in Australia to begin its global Phase 1 clinical trial for CLN-978, a novel CD19xCD3 bispecific T cell engager aimed at treating systemic lupus erythematosus (SLE). This early-stage study will assess the safety, pharmacokinetics, and initial clinical activity of CLN-978 in SLE patients, who currently rely on lifelong immune suppression since existing treatments rarely achieve treatment-free remissions.
The trial, which will be conducted at multiple sites in Australia and other countries, focuses on determining whether CLN-978 can provide a convenient, off-the-shelf therapeutic option. Designed to efficiently target B cells with low levels of CD19, CLN-978 features a half-life extended construct that could potentially reduce toxicity and enhance patient dosing. This approval marks a critical step in Cullinan’s efforts to develop transformative therapies for autoimmune diseases like SLE.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- September 17, 2024
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, 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).
AI Summary
Cullinan Therapeutics recently received approval from Australia’s Human Research Ethics Committee (HREC) to start its global Phase 1 clinical trial of CLN-978, a CD19xCD3 bispecific T cell engager. This early-stage trial is designed to evaluate the safety, pharmacokinetics, and initial clinical activity of CLN-978 in patients with systemic lupus erythematosus (SLE).
SLE is a chronic autoimmune disease that affects hundreds of thousands of people worldwide, often requiring lifelong immune suppression. CLN-978 is developed to target B cells by binding to CD19, aiming to deliver a potent T cell response with convenient, off-the-shelf dosing. The trial will be conducted at multiple international sites, starting in Australia, and represents an important step in Cullinan’s global push to bring innovative treatment options to patients suffering from autoimmune conditions like SLE.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- September 16, 2024
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics 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).
AI Summary
Cullinan Therapeutics, Inc. announced that it has filed an Investigational New Drug (IND) application with the FDA to evaluate its novel CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE). This development is an important step in their efforts to address the needs of over 160,000 patients in the U.S. who suffer from SLE. Unlike current treatments that rely on lifelong immune suppression, CLN-978 is designed to potentially modify the course of the disease.
CLN-978 works by targeting CD19-positive cells, including those with very low levels of CD19, and features a half-life–extending design that may allow for subcutaneous delivery. Cullinan hopes that this therapy could offer a more convenient, off-the-shelf option that delivers potent and disease-modifying effects, ultimately improving the quality of life for patients with SLE.
Read Announcement
zipalertinib - FDA Regulatory Timeline and Events
zipalertinib is a drug developed by Cullinan Therapeutics for the following indication: For patients with heavily pre-treated EGFR ex20ins mutation NSCLC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- zipalertinib
- Announced Date:
- June 1, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO).
AI Summary
Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced the positive publication of the REZILIENT1 trial results in the Journal of Clinical Oncology. This Phase 1/2 global study evaluated the use of zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had already received prior treatments. The trial’s findings show a meaningful clinical response, with an overall objective response rate of about 35% and a median duration of response around 8.8 months in the primary group of 176 patients. These promising results suggest that zipalertinib may offer a new targeted therapy option for those with advanced or metastatic NSCLC, addressing an area of significant unmet need in treatment. Additional details and data from the trial will also be shared during an oral presentation at the upcoming ASCO Annual Meeting.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- January 28, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have received prior therapy, met its primary endpoint of overall response rate.
AI Summary
Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc. have announced promising results from the REZILIENT1 trial. This Phase 1/2 study evaluated zipalertinib (CLN-081/TAS6417) as a monotherapy in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations who had previously received treatment. The trial successfully met its primary endpoint by achieving a significant overall response rate. The data were obtained from the Phase 2b segment of the trial, and the safety profile observed was consistent with earlier findings. Full results will be presented at an upcoming international medical conference, highlighting the potential of zipalertinib to address the needs of patients facing limited treatment options.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- September 14, 2024
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Cullinan Therapeutics, updated data in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations receiving zipalertinib after prior treatment with amivantamab enrolled in Module C of its pivotal Phase 2b REZILIENT1 clinical trial.
AI Summary
Cullinan Therapeutics released updated results from Module C of its pivotal Phase 2b REZILIENT1 clinical trial. The study focused on patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had already been treated with amivantamab. In the trial, zipalertinib demonstrated an objective response rate of 40% among 30 evaluable patients, with 3% achieving a complete response and 37% a partial response. About 50% of the patients experienced stable disease, indicating consistent anti-tumor activity. The safety profile of zipalertinib remained manageable, with common adverse events such as rash, paronychia, and anemia mostly being mild to moderate. The favorable outcomes were similar to earlier study parts where patients received chemotherapy, reinforcing confidence in zipalertinib's potential for heavily pre-treated NSCLC patients. Additionally, the trial enrollment was completed ahead of schedule.
Read Announcement
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