Genetically-Engineered Immune Cells for Lung Cancer
(CheckCell-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for metastatic non-small cell lung cancer (NSCLC) using genetically-engineered immune cells. The treatment modifies Tumor Infiltrating Lymphocytes (TIL) to enhance their effectiveness against cancer cells by inactivating CISH, a gene that can limit immune response. The trial will assess the safety and effectiveness of this approach, with different trial groups based on specific cancer characteristics. Individuals with confirmed metastatic NSCLC who have started or are about to start certain cancer treatments may be eligible to participate. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use systemic steroids (except certain contraceptives) within 21 days before the investigational treatment and after. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Tumor Infiltrating Lymphocytes (TILs) can effectively treat certain cancers, such as non-small cell lung cancer (NSCLC). TILs, a type of immune cell, can attack cancer cells. Some studies have demonstrated their potential to provide lasting and meaningful benefits for patients.
This trial employs a special method called CRISPR to edit genes in these TILs. By turning off a specific gene called CISH, the TILs might work more effectively. In animal studies, disabling CISH in TILs has enhanced their ability to fight tumors.
While these studies are promising, it is important to note that this trial is in an early stage (Phase 1/2). This means the treatment is still being tested for safety and tolerance. Early-stage trials often focus on determining the right dose and checking for any side effects. So far, TIL therapy has generally been well-tolerated in other types of cancer. However, any new treatment may carry risks that are not yet fully understood.
Prospective participants should discuss all potential risks and benefits with their doctor before joining this trial.12345Why do researchers think this study treatment might be promising for lung cancer?
Researchers are excited about CISH inactivated TILs for lung cancer because these treatments leverage a cutting-edge genetic engineering technique using CRISPR to modify tumor-infiltrating lymphocytes (TILs). Unlike traditional therapies like chemotherapy or radiation, which attack cancer cells and can harm healthy cells, this approach enhances the body's own immune cells to specifically target and destroy cancer cells. Another unique feature is the use of high-dose aldesleukin to boost immune response, with some treatment arms also including pembrolizumab to maintain the immune attack against cancer. This personalized and precise method of treatment has the potential to offer more effective and targeted outcomes than current standards of care.
What evidence suggests that this trial's treatments could be effective for Metastatic Non-small Cell Lung Cancer?
Research has shown that specially modified immune cells, called Tumor Infiltrating Lymphocytes (TIL), could help treat advanced Non-small Cell Lung Cancer (NSCLC). In animal studies, turning off a specific checkpoint in these immune cells significantly improved their ability to attack cancer. This trial will examine CISH inactivated TIL therapy, which has already demonstrated lasting and significant results in lung cancer patients, particularly those who have never smoked. The CRISPR technique, used to modify these cells, is known for its accuracy in enhancing immune cell function, potentially making these treatments more effective. Overall, this method offers hope for new possibilities for people with NSCLC.13567
Who Is on the Research Team?
Emil Lou, MD, PhD
Principal Investigator
Division of Hematology, Oncology, and Transplantation, University of Minnesota
Erminia Massarelli, MD, PhD, MS
Principal Investigator
Department of Medical Oncology & Therapeutics Research, City of Hope
Are You a Good Fit for This Trial?
Adults aged 18-70 with metastatic non-small cell lung cancer (NSCLC), either PD-L1 negative or positive, who are candidates for first-line anti-PD-1/anti-PD-L1 immunotherapy with chemo. They must have good organ function, agree to use contraception, and can stay near the treatment site for follow-ups. Exclusions include those with certain medical conditions, prior malignancies within 3 years, severe allergies to specific drugs, recent live vaccines, active infections or coagulation disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by CISH inactivated TIL and high-dose aldesleukin
Follow-up
Participants are monitored for safety and effectiveness after treatment, including maintenance pembrolizumab for some cohorts
Long-term follow-up
Participants are monitored for progression-free survival, duration of response, clinical benefit rate, tumor growth change, overall survival, and toxicity incidence
What Are the Treatments Tested in This Trial?
Interventions
- CISH Inactivated TIL
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intima Bioscience, Inc.
Lead Sponsor