RecruitingPhase 1

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease

United States10 participantsStarted 2026-03

Plain-language summary

This research study aims to evaluate the safety and effectiveness of a novel immunotherapy, Fast TIL, an Adoptive Cellular Therapeutic (ACT), to fight cancer that has spread to the pleura or pleural mesothelioma. The ACT product is created at AHN West Penn using the participant's pleural infiltrating T-cells (PIT). It is administered through a pleural catheter along with the drug Interleukin-2 (IL-2). Based on previous research it is believed that it may help fight the tumor and relieve symptoms. As a participant, their pleural fluid will be collected and the PIT cells will be isolated and expanded in the lab to create the ACT product. Before receiving the ACT product through their pleural catheter, they will undergo outpatient lymphodepleting chemotherapy. LDC is a standard procedure for many approved immunotherapy treatments Following the infusion, they'll receive IL-2 through the catheter for two days to stimulate the expanded PIT cells. The active treatment phase lasts about three weeks, with follow-up visits over five years at AHN West Penn Hospital, potentially requiring a hospital stay of up to six days. Blood samples will be taken to monitor their response. As this is a first-in-human study, treatment carries an unknown risk up to and including death from toxicity. However, the risks of similar immunotherapy treatments are well documented.

Who can participate

Age range18 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.
✓. Patients will be ≥ 18 and \< 80 years of age.
✓. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 6 months after ACT administration. Male participants must be willing to practice birth control from the time of enrollment on this study and for 6 months after receiving the preparative regimen.
✓. Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography.
✓. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.
✓. Karnofsky performance score ≥ 70.
✓. Patients must have an expected survival \> 12 weeks.
✓. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.

What they're measuring

Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device

Timeframe: 30 days

Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device

Timeframe: 30 days

Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device

Timeframe: 30 days

To demonstrate the safety of intrapleural administration of the locally manufactured ACT product plus Interleukin 2 (IL-2) to study patients

Timeframe: 5 years

Trial details

NCT IDNCT07192900

SponsorDavid Bartlett, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-12

Contact for this trial

David Bartlett, MD

412-359-3731 david.bartlett@ahn.org

View on ClinicalTrials.gov More Malignant Pleural Effusion trials

Plain-language summary

Who can participate

Age range18 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.
✓. Patients will be ≥ 18 and \< 80 years of age.
✓. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 6 months after ACT administration. Male participants must be willing to practice birth control from the time of enrollment on this study and for 6 months after receiving the preparative regimen.
✓. Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography.
✓. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.
✓. Karnofsky performance score ≥ 70.
✓. Patients must have an expected survival \> 12 weeks.
✓. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.

What they're measuring

Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device

Timeframe: 30 days

Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device

Timeframe: 30 days

Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device

Timeframe: 30 days

To demonstrate the safety of intrapleural administration of the locally manufactured ACT product plus Interleukin 2 (IL-2) to study patients

Timeframe: 5 years

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria