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Explore Cullinan’s Clinical Trials

Cullinan Therapeutics’ global clinical development is focused on researching and advancing investigational treatments to establish new standards of care in autoimmune diseases and cancer. Our clinical trials are designed to assess safety and tolerability, and address treatment gaps with the goal of delivering meaningful improvements for people living with these conditions.

“ Scientific discovery carries the most weight when we can translate what is happening in the lab to improve the daily reality for people living with autoimmune diseases and cancer. The participation and engagement by patients, their families, and investigators in clinical trials is key to the development process — thanks to their support, we have more insight into how innovative treatments can impact the lives of those facing unmet needs.”

– Jeff Jones, MD, MBA, Chief Medical Officer

HOW CLINICAL TRIALS WORk

Clinical trials are studies that research investigational new treatments and provide an understanding of how those treatments will impact people, including whether they are safe and effective. Participating in a clinical trial can help create new treatment options for those with autoimmune diseases and cancer.

  • BEFORE

    It’s important that the decision to participate in a clinical trial is an informed choice. Before enrolling in a trial, a person should weigh the potential benefits, risks, and time commitment of participating in a study by talking with their doctor and their loved ones.

    When deciding if participating in a clinical trial is right, a doctor can help connect a potential participant with the relevant clinical trial team to complete the necessary steps before enrollment, such as pre-screening (where researchers will gather preliminary eligibility information like age and disease diagnosis) and informed consent (where potential participants are provided with all the information necessary to make an informed decision about whether to participate in a study).

  • During

    If qualified for a clinical trial, the potential participant will receive detailed instructions on the trial’s procedures, including what they need to do and how often. Researchers will monitor their health throughout the entire study, and they may make decisions to protect the participant’s best interests, such as stopping participation if they experience certain side effects.

    Participating in clinical trials can result in side effects or discomfort from treatment, and it can also be more time-consuming than regular care. However, clinical trials can also provide the opportunity to access new research and investigational therapeutics before they become widely available. Participating in a clinical study offers a chance to take an active role in one’s care and helps shape the future of research and treatment for upcoming generations.

  • After

    Once a participant reaches the end of their clinical trial, the doctor will talk about any next steps regarding care, and trial researchers may follow up with the participant to see how they are doing.

    Additionally, researchers will review the study data from the clinical trial to inform future decisions, such as moving a trial into the next phase of research, or applying for FDA or other health authority approval of the investigational therapy.

DIVERSITY, EQUITY, AND INCLUSION

Diversity, equity, and inclusion are not merely an initiative at Cullinan—they are core practices that permeate every facet of our organization, including our clinical development programs. We focus on the diverse experiences of people with autoimmune diseases and cancer with the goals of improving treatment solutions and bringing forward new medicines that have better efficacy and/or safety than what is currently available.

We are dedicated to ensuring that our clinical trials engage the full range of people who could ultimately benefit from our investigational medicines. Achieving this requires meaningful partnerships across the healthcare ecosystem to remove barriers to access, expand participation, and tackle the unique challenges faced by underserved communities.

OUR CLINICAL TRIALs

All of Cullinan Therapeutics’ assets are investigational and have not been approved by any health authorities.

AUTOIMMUNE DISEASEs

Condition Study Status Study Details Share
Condition
Rheumatoid arthritis
Study
OUTRACE RA This Phase 1 study of CLN-978 is evaluating safety, as well as potential effects on disease activity and the immune system.
Status
Recruiting
Study Details
PDF
Condition
Sjögren’s disease
Study
OUTRACE Sjögren’s This Phase 1b study of CLN-978 is evaluating safety, as well as potential effects on disease activity and the immune system.
Status
Recruiting
Study Details
PDF
Condition
Systemic lupus erythematous
Study
OUTRACE SLE This Phase 1b clinical study of CLN-978 is evaluating safety, as well as potential effects on disease activity and the immune system.
Status
Recruiting
Study Details
PDF

CANCEr

Condition Study Status Share
Condition
Acute myeloid leukemia and myelodysplastic syndrome
Study
Phase 1 Study of CLN-049 This Phase 1 clinical trial is evaluating safety and preliminary efficacy of CLN-049.
Status
Recruiting
Condition
Non-small cell lung cancer
Study
REZILIENT1 Trial This Phase 1/2 clinical trial is evaluating safety, tolerability, and preliminary efficacy of zipalertinib in patients with NSCLC harboring EGFR (epidermal growth factor receptor) exon 20 insertion (ex20ins) mutations.
Status
Active, Not Recruiting
Condition
Non-small cell lung cancer
Study
REZILIENT2 Trial This Phase 2 clinical trial is evaluating safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations. This study is sponsored by Taiho Oncology.
Status
Recruiting
Condition
Non-small cell lung cancer
Study
REZILIENT3 Trial This Phase 3 clinical trial is evaluating safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy, compared to chemotherapy alone. This study is sponsored by Taiho Oncology.
Status
Recruiting

CULLINAN THERAPEUTICS EXPANDED ACCESS POLICY

At this time, Cullinan Therapeutics does not provide its investigational treatments outside of clinical trials. We believe participation in clinical trials is the safest and most effective way for patients to access our investigational treatments while allowing us to rigorously evaluate safety and efficacy.

We are committed to advancing the development of high-impact therapies for autoimmune diseases and cancer, and patient participation in our clinical trials is essential to move scientific discovery into meaningful improvements in care.

For more information on Cullinan’s currently enrolling clinical trials, please visit www.clinicaltrials.gov or contact Cullinan at https://cullinantherapeutics.com/contact/.