TIL Therapy for Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Amir A. Jazaeri

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a treatment using a patient's own immune cells to fight various cancers that haven't responded to other treatments or have come back. The immune cells are taken from the tumor, grown in a lab, and then reintroduced into the body to target and kill cancer cells. The study aims to see how well this approach works and how safe it is.

Research Team

Amir A. Jazaeri

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

I can have a piece of my tumor removed for testing, separate from the main cancer area.

I stopped any cancer treatments 28 days before enrolling for TIL therapy, except with PI approval for palliative care.

My heart test (stress echo) results were normal, or I had an alternative heart check approved by a cardiologist.

Exclusion Criteria

I do not have severe ongoing side effects from previous treatments, active hepatitis, heart issues, or a history of certain cell therapies.

I had severe diarrhea or colitis from past immunotherapy but have been symptom-free for 6 months or had a normal colonoscopy.

I do not have any severe ongoing illnesses that are not under control.

Treatment Details

Interventions

• Autologous Tumor Infiltrating Lymphocytes LN-145 (CAR T-cell Therapy)
• Autologous Tumor Infiltrating Lymphocytes LN-145-S1 (CAR T-cell Therapy)

Trial Overview The trial is testing LN-145 and LN-145-S1, which are therapies using the patient's own T-cells grown from their tumors to fight cancer. It examines how well these cells can target and destroy cancer cells in patients who haven't responded to standard treatments.

Participant Groups

Group I: Thyroid Cohort (LN-145) Experimental Treatment 6 Interventions

Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine IV over 15-30 minutes daily on days -5 to -1, autologous tumor infiltrating lymphocytes LN-145 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses.

Group II: ICI Ovarian Cancer, Sarcomas, Triple Negative Breast Cancer (LN-145-S1, nivolumab) Experimental Treatment 9 Interventions

Ipilimumab will be administered as a single dose prior to tumor resection. Nivolumab will be administered once prior to tumor resection. Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine IV over 15-30 minutes daily on days -5 to -1, LN-145-S1 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses. Within 12 weeks after receiving LN-145-S1, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks and continued until unacceptable toxicity, progression, or start of another cancer therapy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Iovance Biotherapeutics, Inc.

Industry Sponsor

Trials

26

Recruited

1,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School