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CAR T-cell Therapy

STIL101 Therapy for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Vincent Chung

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: ≥ 18 years

Agree to research biopsies while on-study

Must not have

Prior organ transplant

Concomitant herbal medications except cannabidiol (CBD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of stil101 for injection infusion for at least one post-treatment scan up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called STIL101 for injection in patients with pancreatic cancer, colorectal cancer, renal cell cancer, cervical cancer, and melanoma that has spread or cannot be removed by

Who is the study for?

This trial is for patients with certain advanced cancers (pancreatic, colorectal, renal cell, cervical, and melanoma) that have spread or can't be removed by surgery. Participants must have a tumor from which T cells can be collected to create the STIL101 injection.

What is being tested?

The trial tests STIL101 injections made from a patient's own T cells against locally advanced or metastatic pancreatic cancer, CRC, RCC, CC and melanoma. It includes pre-treatment with chemotherapy (cyclophosphamide and fludarabine) and aldesleukin to enhance T cell activity.

What are the potential side effects?

Potential side effects include reactions at the injection site, flu-like symptoms due to immune activation (fever, fatigue), possible organ inflammation as the immune system becomes more active in attacking the tumor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I agree to have biopsies for research while participating in the study.

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I am fully active and can carry on all pre-disease activities without restriction.

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I have a tumor that can be safely biopsied and is larger than 1cm^3.

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My kidney function, measured by a test, is good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant.

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I am not taking herbal medications, except for CBD.

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I am currently being treated for an active infection.

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I am on more than 10 mg/day of steroids or other drugs that suppress my immune system.

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I have a severe heart condition.

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I am on hemodialysis for end-stage kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of stil101 for injection infusion for at least one post-treatment scan up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of stil101 for injection infusion for at least one post-treatment scan up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of stil101 for injection infusion for at least one post-treatment scan up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infusion limiting toxicities (ILTs)

Treatment-related adverse events (AEs)

Secondary study objectives

Disease control rate

Excisional biopsy complication rate

Failure to receive STIL101 after excisional biopsy

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (STIL101 for injection)Experimental Treatment10 Interventions

Patients undergo excisional biopsy and continue receiving standard of care therapy for 3-4 months prior to the start of study therapy. Patients with successful generation of STIL101 for injection receive cyclophosphamide IV over 2 hours on days -5 to -4, fludarabine IV over 30 minutes on days -5 to -1 and STIL101 for injection IV on day 0 in the absence of disease progression or unacceptable toxicity. Patients also receive aldesleukin SC QD on day 0 for up to 6-10 days. Additionally, patients undergo blood sample collection, biopsy, CT and optional MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Excisional Biopsy

2017

N/A

~50