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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called STIL101 for Injection, derived from a person's own T cells, a type of white blood cell. The goal is to determine if this treatment can safely and effectively target and attack tumors in individuals with advanced or hard-to-operate cancers, such as pancreatic, colorectal, renal, cervical, and melanoma. Participants will receive a combination of chemotherapy and STIL101, along with aldesleukin to enhance their immune response. This trial suits individuals with these specific cancers who have tried at least one standard treatment and have tumors that cannot be surgically removed. To participate, volunteers should have measurable disease and be willing to undergo medical procedures like biopsies. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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).

Is there any evidence suggesting that STIL101 for injection is likely to be safe for humans?

Research has shown that STIL101 for injection might be safe and manageable for patients with certain cancers, such as pancreatic and colorectal cancer. This treatment uses a patient's own T cells, a type of white blood cell, to attack tumors. Lab studies have demonstrated that STIL101 for injection can reduce or slow tumor growth in various cancers, including melanoma and pancreatic cancer.

Since this trial is in the early stages, it primarily focuses on understanding safety, so information on side effects in humans is limited. However, this phase aims to identify any safety issues before more extensive testing. Researchers are closely monitoring how well patients tolerate the treatment and any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for pancreatic cancer?

STIL101 for injection is unique because it combines a novel approach with the existing standard of care for pancreatic cancer, which typically includes chemotherapy and sometimes radiation. Unlike current treatments that primarily target cancer cells directly, STIL101 works by enhancing the patient's immune response to attack the cancer more effectively. Researchers are excited about this treatment because it includes a new active ingredient that could potentially improve how the immune system recognizes and fights pancreatic cancer cells. This innovative combination of boosting immune activity while continuing standard treatments offers hope for better outcomes in a condition that is notoriously difficult to treat.

What evidence suggests that STIL101 for injection might be an effective treatment for pancreatic cancer?

This trial will evaluate STIL101, a personalized T-cell therapy, for its potential to slow or reduce tumor growth in pancreatic cancer. Studies have shown that STIL101 can effectively find and attack cancer cells in various cancers, including pancreatic cancer and melanoma. In lab tests on animals, STIL101 effectively targeted cancer cells. This treatment uses a patient's own immune cells, which are grown and strengthened to better fight cancer, aiming to boost the immune system's ability to attack cancer cells. While research on humans is ongoing, early results are promising and suggest this approach might help treat difficult cancers. ^{1 3 5 6 7}

Who Is on the Research Team?

Vincent Chung, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06626256?cond=%22Cervical+Cancer%22

Study Details | NCT06626256 | STIL101 for Injection for the ... Giving STIL101 for injection may be safe, tolerable and/or effective in treating patients with locally advanced, metastatic or unresectable pancreatic cancer, ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08121

STIL101 for Injection for the Treatment of Locally Advanced ... Giving STIL101 for injection may be safe, tolerable and/or effective in treating patients with locally advanced, metastatic or unresectable pancreatic cancer, ...

3. researchgate.net researchgate.net/publication/385556968_681_Clinical_development_of_STL-101_a_personalized_TIL_therapy_for_treatment_of_advance_solid_tumors

681 Clinical development of STL-101, a personalized TIL ... In xenograft studies, STIL-101 has demonstrated the ability to reduce or limit tumor growth in various types, including melanoma and pancreatic ...

4. synapse.patsnap.com synapse.patsnap.com/drug/73e254dd6f344996bd96c09d901adc58

STIL-101 - Drug Targets, Indications, Patents A Phase 1 Safety and Efficacy Study of STIL101 for Injection in Locally Advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma, Colorectal ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528555/

Emerging therapeutic advancements in pancreatic cancer Vaccine therapy boosts immune system's response against cancer via exposing cancer-associated antigens to T cells [119]. Although conventional ...

6. trial.medpath.com trial.medpath.com/clinical-trial/2e8b7abef8167e0b/nct06626256-safety-efficacy-study-stil101-cancer

STIL101 for Injection for the Treatment of Locally Advanced ... 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, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06861543

NCT06861543 | The Purpose of This Study is to Evaluate ... This is a first-in-human, single-arm, open-label, dose escalation prospective phase I clinical study to evaluate the Safety, Tolerability and Efficacy of ...