Using modified T-cells to treat lung cancer

Administration of T Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch in Subjects With Lung Cancer

This study is testing a new treatment using modified immune cells to see if they can help adults with advanced lung cancer that hasn't responded to other therapies.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UNC Lineberger Comprehensive Cancer Center (other)
• Drugs / interventions: chemotherapy, prednisone, chimeric antigen receptor
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT05620342 on ClinicalTrials.gov

What this trial studies

This phase 1, single-center, open-label study aims to evaluate the safety of autologous T lymphocyte chimeric antigen receptor cells targeting the GD2 antigen in adults with extensive stage lung cancer or stage IV non-small cell lung cancer that is resistant to platinum-based chemotherapy and has received PD-1 or PD-L1 therapy. The study will determine the maximum tolerated dose of these modified immune cells, which combine the properties of antibodies and T cells to attack tumor cells. Participants will undergo cell procurement and receive an infusion of the modified T-cells as part of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults with extensive stage lung cancer or stage IV non-small cell lung cancer who are platinum-refractory and have received PD-1 or PD-L1 therapy.

Not a fit: Patients with a life expectancy of less than 12 weeks or those who have not received platinum-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer who have limited treatment alternatives.

How similar studies have performed: Other studies using CAR T-cell therapies have shown promising results in various cancers, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent to undergo cell procurement explained to, understood by, and signed by the subject.
2. Subject has a life expectancy of ≥ 12 weeks.
3. Subject must be platinum-refractory and either currently receiving or has previously received a PD1/PDL1 inhibitor
4. Use of systemic corticosteroids at doses ≥10 mg prednisone daily or it's equivalent; those receiving \<10 mg daily may be enrolled at the discretion of the investigator.
5. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement.
6. Subject has demonstrated adequate organ function.

Exclusion Criteria:

1 . Subject has less than 12 weeks of life expectancy.

2\. Subject did not receive platinum-based chemotherapy

3\. Subject does not have adequate organ function.

Where this trial is running

Chapel Hill, North Carolina

• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Jared Weiss — [e-mail]
• Study coordinator: Catherine Cheng

Conditions: Lung Cancer, Small Cell Lung Carcinoma, Non Small Cell Lung Cancer, cellular therapy