TIL Therapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies new treatments for certain types of cancer, including ovarian cancer, triple-negative breast cancer, anaplastic thyroid cancer, and specific bone and soft tissue sarcomas. Researchers are testing whether special white blood cells, taken from a patient's tumor, can effectively target and destroy cancer cells. Participants might receive different versions of these cell treatments, known as Autologous Tumor Infiltrating Lymphocytes LN-145. This trial may suit individuals whose cancer has not responded to treatment or has returned, and who have a tumor that can be biopsied for cell collection. As a Phase 2 trial, this research focuses on measuring how well the treatment works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, and biologic/targeted agents, must be stopped at least 28 days before enrollment. However, palliative therapy may be allowed during the screening period with approval from the principal investigator.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments using a patient's own immune cells, known as tumor infiltrating lymphocytes (TILs), such as LN-145 and LN-145-S1, have been studied in various cancers. These treatments involve extracting T-cells from a patient’s tumor, cultivating them in a lab, and then reintroducing them to the patient to combat the cancer.
For LN-145, studies have found it to be generally well-tolerated. Specifically, in patients with cervical cancer, the treatment demonstrated an acceptable safety profile, meaning it did not cause severe unexpected side effects. Similarly, research with head and neck cancer patients found that combining LN-145 with pembrolizumab was safe and showed promising results.
Regarding LN-145-S1, studies also suggest it is safe to use. One study indicated that this treatment could be a potential option for head and neck cancer, with safety data supporting further research.
It is important to note that while these treatments show promise, they remain under study. They are not yet approved for all conditions, and the full range of possible side effects is still being understood.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they harness the power of the body's own immune cells, specifically tumor-infiltrating lymphocytes (TILs), to fight cancer. Unlike traditional treatments like chemotherapy and radiation, which target cancer cells broadly, TIL therapy involves using a patient's own immune cells, which are grown and activated outside the body before being reintroduced to target cancer more precisely. Additionally, the combination of TILs with immune checkpoint inhibitors like nivolumab and ipilimumab provides a two-pronged attack, potentially enhancing the immune response against tumors. This unique approach offers hope for patients with hard-to-treat cancers, like ovarian cancer, sarcomas, triple negative breast cancer, and thyroid cancer, by targeting cancer cells in a highly personalized way.
What evidence suggests that this trial's treatments could be effective for cancer?
Research shows that certain immune cells, called tumor-infiltrating lymphocytes (TILs), can effectively attack and destroy cancer cells, especially in patients with solid tumors like melanoma. This trial studies LN-145 and LN-145-S1 treatments. LN-145, used in the thyroid cohort, involves TILs taken from a patient's tumor and grown in a lab. Studies have shown promising results with LN-145, where 66% of patients experienced a complete response, meaning their cancer disappeared. LN-145-S1, part of the treatment for ovarian cancer, sarcomas, and triple-negative breast cancer, uses a special method to select specific T-cells, aiming to enhance effectiveness. Early findings suggest these treatments could help patients with ovarian cancer, triple-negative breast cancer, anaplastic thyroid cancer, and certain sarcomas that have not responded to other treatments.16789
Who Is on the Research Team?
Amir A. Jazaeri
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with specific types of cancer (ovarian, TNBC, thyroid, osteosarcoma or other bone/soft tissue sarcomas) that are resistant to treatment or have returned. Participants must have a tumor suitable for biopsy and meet certain health criteria like heart and lung function tests. They should not be HIV positive or have uncontrolled illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive cyclophosphamide, fludarabine, LN-145 or LN-145-S1, and aldesleukin. For some cohorts, nivolumab and ipilimumab are also administered.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 18 weeks, 6, 9, 12, 18, and 24 months, then every 3 months for at least 3 years.
Extension
Participants may continue to receive nivolumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Tumor Infiltrating Lymphocytes LN-145
- Autologous Tumor Infiltrating Lymphocytes LN-145-S1
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Iovance Biotherapeutics, Inc.
Industry Sponsor
National Cancer Institute (NCI)
Collaborator