Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease

NCT07192900 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 2025-089HT94252411067RIOT 4AFast TILS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Mesothelioma; Metastasis to Pleura; Malignant Pleural Effusion; Pleural Effusion, Malignant

Keywords

metastasis to pleura; pleural infiltrating T cells; CliniMACS Prodigy; malignant mesothelioma; pleural effusion, malignant; Adoptive Cellular Therapeutic; immunotherapy; autologous tumor infiltrating lymphocytes (TIL)

Outcome Measures

Primary Outcomes (4)

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

  flow cytometry for cellular ACT identity

  30 days

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

  cytotoxicity assays for ACT potency

  30 days

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

  flow cytometry for cellular ACT purity

  30 days

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

  incidence of Treatment-Emergent Adverse Events (Safety) of intrapleural administration of the locally manufactured ACT product, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  5 years

Secondary Outcomes (4)

• To document changes in the pleural fluid secretome secondary to local therapeutic ACT product infusion.

  30 days

• To document changes in the pleural cellular composition secondary to local therapeutic ACT product infusion

  30 days

• To document the overall response rates to therapy

  60 days

• To document the complete response rates to therapy

  60 days

Study Arms (1)

locally manufactured adoptive cellular therapeutic (ACT) product

EXPERIMENTAL

Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells. Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU).

Biological: locally manufactured adoptive cellular therapy (ACT) product; Drug: Interleukin-2

Interventions

locally manufactured adoptive cellular therapy (ACT) product BIOLOGICAL

Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells.

Also known as: ACT, Fast TIL

locally manufactured adoptive cellular therapeutic (ACT) product

Interleukin-2 DRUG

Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU).

Also known as: IL-2, Proleukin

locally manufactured adoptive cellular therapeutic (ACT) product

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must consent to collection of demographic and clinical data.

You may not qualify if:

• Patients with breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, and melanoma.
• Infection with Human Immunodeficiency Virus (HIV) and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol.
• Infection with hepatitis B and active viral replication.
• Infection with hepatitis C and active viral replication.
• Patients currently being treated for bacterial, fungal or viral infection.
• Documented myocardial infarction within 6 months of study participation and/or symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.
• Investigational drug use within 30 days before effusion collection.
• Corticosteroid therapy \> 10 milligrams (mg) of prednisone (biological equivalent) daily within 2 weeks before effusion collection.
• Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician.
• Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease:
• AST/SGOT \> 2.0 times the upper limit of normal ALT/SGPT \> 2.0 times the upper limit of normal Total bilirubin \> 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (\>3.0 times the upper limit of normal) Hemoglobin \< 8 gm/dL or dependent upon transfusion to maintain ≥ 8 gm/dL White blood cell count \< 2,000/mm3 Platelet count \< 100,000/mm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine \> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL/min.
• Pregnant or lactating females.
• Prior solid organ transplantation
• Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.
• Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures.

Sponsors & Collaborators

• David Bartlett, MD: lead
• Miltenyi Biotec, Inc.: collaborator
• Iovance Biotherapeutics, Inc.: collaborator
• UPMC Hillman Cancer Center: collaborator

Study Sites (1)

AHN West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant; Mesothelioma, Malignant

Interventions

Pharmaceutical Preparations; Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Lung Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• David Bartlett, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Bartlett, MD

CONTACT

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

AHN Clinical Trial Contact

CONTACT

412-359-3731; clinicaltrials@ahn.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, AHN Cancer Institute; President, AHN Research Institute

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 25, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2037
• Last Updated: January 15, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data and biosamples will be shared with UPMC Hillman Cancer Center throughout the study until the end of the statistical analysis.

Locations

US (1)