STIL101 Therapy for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must not be taking: Systemic steroids, Immunosuppressives

Disqualifiers: Organ transplant, Active infection, others

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

Compensation: Varies

Number of Visits: 42

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take herbal medications (except CBD) or continuous systemic steroid therapy (more than 10 mg/day of prednisone or equivalent).

What is the purpose of this trial?

This phase I trial tests the safety and side effects of STIL101 for injection and how well it works in treating patients with pancreatic cancer, colorectal cancer (CRC), renal cell cancer (RCC), cervical cancer (CC) and melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). STIL101 for injection, an autologous (made from the patients own cells) cellular therapy, is made up of specialized white blood cells called lymphocytes or "T cells" collected from a piece of the patients tumor tissue. The T cells collected from the tumor are then grown in a laboratory to create STIL101 for injection. STIL101 for injection is then given to the patient where it may attack the tumor. Giving chemotherapy, such as cyclophosphamide and fludarabine, helps prepare the body to receive STIL101 for injection in a way that allows the T cells the best opportunity to attack the tumor. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes. Aldesleukin increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Giving STIL101 for injection may be safe, tolerable and/or effective in treating patients with locally advanced, metastatic or unresectable pancreatic cancer, CRC, RCC, CC and melanoma.

Research Team

Vincent Chung, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.

Inclusion Criteria

AST ≤ 3 x ULN; ≤ 5.0 x ULN if hepatic metastases are present

INR or PT ≤ 1.5 x ULN if not receiving anticoagulants

Oxygen saturation > 92% on room air not requiring oxygen supplementation

Exclusion Criteria

History of allergic reactions to study agents

Primary immunodeficiency

Pregnant or breastfeeding (females only)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Patients undergo excisional biopsy and continue receiving standard of care therapy for 3-4 months prior to the start of study therapy

3-4 months

Lymphodepleting Chemotherapy

Patients receive cyclophosphamide and fludarabine intravenously to prepare the body for STIL101 infusion

5 days

STIL101 Treatment

STIL101 for injection is administered intravenously, followed by aldesleukin subcutaneously for up to 6-10 days

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Follow-up visits at days 42, 56, 70, 84, then every 2-4 weeks up to week 96 or progression

Treatment Details

Interventions

• STIL101 for Injection

Trial Overview 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.

Participant Groups

Group I: Treatment (STIL101 for injection) Experimental Treatment 10 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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+