Genetically Modified T-Cells for Pancreatic Cancer

Overseen By IMTX Intake Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fred Hutchinson Cancer Center

Must not be taking: Corticosteroids, Investigational agents

Disqualifiers: Pregnancy, Autoimmune disease, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

9 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for advanced pancreatic cancer using modified immune cells from the patient. These cells are changed to better recognize and attack cancer cells. The goal is to find the best dose and see if this approach can help patients whose cancer has spread.

Research Team

Elena Chiorean

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

Adults with metastatic pancreatic ductal adenocarcinoma who've had at least one systemic therapy can join. They must have a life expectancy over 3 months, be willing to undergo tumor biopsies, and not have received recent treatments that could interfere. Participants need properly functioning major organs, no severe autoimmune diseases or organ transplants, and agree to use contraception.

Inclusion Criteria

I have had at least one treatment for cancer that has spread.

Estimated glomerular filtration rate (eGFR) > 60 mL/min

Total bilirubin (bili) =< 1.5 X ULN. Patients with suspected Gilbert syndrome may be included if total bili > 3 mg/dL but no other evidence of hepatic dysfunction

Exclusion Criteria

Concurrent use of other investigational anti-cancer agents

Active autoimmune disease

I currently have an infection that isn't under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion Chemotherapy

Patients receive cyclophosphamide and fludarabine intravenously on days -5, -4, and -3 or optionally bendamustine on days -4 and -3 prior to the first T cell infusion

1 week

3 visits (in-person)

T-Cell Therapy

Patients receive FH-TCR-Tᴍsʟɴ intravenously over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Treatment Details

Interventions

• Autologous Mesothelin-specific TCR-T Cells

Trial Overview The trial is testing FH-TCR-Tᴍsʟɴ T-cells designed to target mesothelin on cancer cells combined with chemotherapy drugs like cyclophosphamide and fludarabine. The goal is to find the safest dose that helps these modified T-cells better attack the tumor cells in patients with advanced pancreatic cancer.

Participant Groups

Group I: Cohorts I, II, and III (FH-TCR Tᴍsʟɴ) Experimental Treatment 4 Interventions

LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -5, -4 and -3 or may optionally receive bendamustine IV on days -4 and -3 prior to the 1st T cell infusion. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.

Group II: Cohort IV (FH-TCR Tᴍsʟɴ) (Discontinued with amendment 3/28/23) Experimental Treatment 3 Interventions

LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -3 to -1. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Lonza Walkersville, Inc.

Industry Sponsor

Trials

1

Recruited

9+