STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma

Summary

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.

Conditions

• Locally Advanced Cervical Carcinoma
• Locally Advanced Colorectal Carcinoma
• Locally Advanced Malignant Solid Neoplasm
• Locally Advanced Melanoma
• Locally Advanced Pancreatic Ductal Adenocarcinoma
• Locally Advanced Renal Cell Carcinoma
• Metastatic Cervical Carcinoma
• Metastatic Colorectal Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Pancreatic Ductal Adenocarcinoma
• Metastatic Renal Cell Carcinoma
• Stage II Pancreatic Cancer AJCC v8
• Stage III Cervical Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Cervical Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Unresectable Cervical Carcinoma
• Unresectable Colorectal Carcinoma
• Unresectable Malignant Solid Neoplasm
• Unresectable Melanoma
• Unresectable Pancreatic Ductal Adenocarcinoma
• Unresectable Renal Cell Carcinoma

Interventions

BIOLOGICAL

Aldesleukin

Given SC

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Excisional Biopsy

Undergo excisional biopsy

DRUG

Fludarabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Standard Treatment

Receive standard of care therapy

BIOLOGICAL

Therapeutic Tumor Infiltrating Lymphocytes

Given STIL101 for injection IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Vincent Chung · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-05

Primary Completion

2027-10-30

Completion

2027-10-30

FDA Drug

Yes