RecruitingRare disease

Study of TCR-Modified T Cell Therapy with ANOC-001, ANOC-002, and ANOC-003 for Adults with Advanced Pancreatic Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Pancreatic Ductal Adenocarcinoma (PDAC), which is a common form of pancreatic cancer. The study is testing a new treatment called ANOC-001, which is a type of cell therapy. This treatment involves modifying a patient's own T-cells, which are a part of the immune system, to better recognize and attack cancer cells. The study also includes two other similar treatments, ANOC-002 and ANOC-003. These treatments are specifically designed to target a mutation in a gene known as KRAS, which is often found in pancreatic cancer cells.

The purpose of the study is to assess the safety and tolerability of these treatments in patients with advanced or metastatic PDAC. The study will be conducted in two phases. In the first phase, the focus will be on determining how safe the treatments are and how well patients can tolerate them. In the second phase, the study will continue to monitor safety and will also look at how effective the treatments are in fighting the cancer. Patients will receive the treatment through an IV infusion, which means the medicine is given directly into a vein.

Throughout the study, patients will be closely monitored for any side effects and to see how their cancer responds to the treatment. The study aims to find out if these new treatments can help control the cancer and improve the quality of life for patients with PDAC. The trial will also explore how long the modified T-cells stay active in the body and how they affect the cancer over time. This research is important for developing new ways to treat pancreatic cancer, especially for those with specific genetic markers like the KRAS mutation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and genetic markers.
A pre-screening process ensures that the patient meets the necessary conditions, such as having a specific type of pancreatic cancer and certain genetic characteristics.
Step 2
Leukapheresis
Leukapheresis is a procedure to collect white blood cells, which are then modified for the therapy. This requires adequate venous access and confirmation of specific genetic mutations.
Patients must not have started certain standard treatments or be in early treatment cycles to undergo leukapheresis.
Step 3
Treatment preparation
Before starting treatment, patients must have a stable health status and meet specific laboratory criteria, such as kidney and liver function tests.
Baseline imaging is required to assess the disease, and patients must be at least two to three weeks from their last systemic treatment.
Step 4
Treatment with ANOC-001
The treatment involves the administration of ANOC-001, a suspension for intravenous infusion. The dosage and frequency are determined based on the patient's response and tolerance.
The primary goal is to assess the safety and tolerability of the treatment, with a focus on monitoring any adverse effects.
Step 5
Follow-up and monitoring
Regular follow-up visits are scheduled to monitor the patient's response to the treatment and any side effects.
The effectiveness of the treatment is evaluated through imaging and other assessments at specified intervals.
Step 6
End of study participation
The study concludes with a final assessment of the patient's health status and the overall outcomes of the treatment.
Patients receive guidance on any further medical care needed after the study.

Who can join the trial?

20 criteria

Must be an adult, 18 years or older, with a new diagnosis of **metastatic** or **locally advanced pancreatic cancer**.
Must have a good general health status, as measured by specific performance scales (ECOG ≤1 or Karnofsky ≥70%).
Must have a **creatinine clearance** (a measure of kidney function) of at least 50 mL/min.
Must have a **total bilirubin** level (a measure of liver function) less than 2.0 mg/dL.
Must have a confirmed **HLA** type (a genetic marker) of HLA-A*11:01 or HLA-A*03:01.
Must have a confirmed **KRAS mutation** (a specific genetic change) in the tumor.
Must not have started or be in early cycles of standard cancer treatment.
Must have suitable veins for a procedure called **leukapheresis** (a process to collect white blood cells).
Must show clinical benefit from standard treatments without disease progression.
Must have measurable disease according to specific criteria (RECIST 1.1) and have recent imaging tests.
Must be at least two to three weeks from the last cancer treatment, unless certain conditions are met.
Must use effective birth control methods if fertile, before, during, and after the study.
Must have certain liver enzyme levels (AST and ALT) less than five times the normal limit.
May be included if suspected of having high bilirubin levels but no other liver issues.
Must have a certain level of **neutrophils** (a type of white blood cell) of at least 1000 cells/mm³.
Must have a certain level of **albumin** (a protein in the blood) of at least 3 g/dL.
Must avoid using certain supportive therapies within 72 hours of sample collection.
Must be able to understand and provide written consent for participation.
Must be willing and able to follow all study procedures and requirements.
Must have a confirmed diagnosis of pancreatic cancer through a biopsy.

Who cannot join the trial?

10 criteria

Patients who do not have a **KRAS mutation**. This is a change in a specific gene that can affect cancer growth.
Patients who are not matched to the specific **TCR-T product**. This is a type of treatment that uses modified immune cells to target cancer.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have received another experimental treatment within a certain time frame before the study.
Patients who have had a recent major surgery.
Patients with active infections that require treatment.
Patients who have a history of other cancers, unless they have been in remission for a certain period.
Patients who have a known allergy to any component of the study treatment.
Patients who are unable to follow the study procedures or attend required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Verified
Amsterdam, The Netherlands
Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Stichting Radboud University Medical Center
Responsive
Nijmegen, The Netherlands

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Investigated drugs

ANOC-001
is a type of therapy that uses modified T-cells to target specific cancer cells in patients with pancreatic cancer. These T-cells are taken from the patient's own body and are altered to better recognize and attack cancer cells that have a specific mutation known as KRAS. This therapy is designed to help the immune system fight the cancer more effectively.
ANOC-002
is another therapy that involves modifying the patient's own T-cells to target cancer cells with a specific KRAS mutation. Like ANOC-001, this therapy aims to enhance the body's natural ability to combat cancer by using specially engineered T-cells to identify and destroy cancerous cells in pancreatic cancer patients.
ANOC-003
is similar to ANOC-001 and ANOC-002, as it also involves the use of modified T-cells to target cancer cells with a KRAS mutation. This therapy is part of a personalized treatment approach, where the patient's own immune cells are used to improve the body's response to cancer, specifically in cases of pancreatic cancer.

ANOC-001

What is already known about the treatment

ANOC-001
This medication is administered as an autologous TCR-modified T-cell therapy, specifically designed for patients with pancreatic ductal adenocarcinoma (PDAC) who have certain genetic markers. It is currently in Phase 1/2 clinical trials, focusing on its safety and effectiveness. The main therapeutic indication is for treating metastatic or locally advanced PDAC. The mechanism of action involves targeting mutated KRAS proteins in cancer cells, using modified T-cells to recognize and attack these cells. It falls under the pharmacological classification of immunotherapy.
ANOC-002
Administered similarly to ANOC-001, this medication is also an autologous TCR-modified T-cell therapy for PDAC patients with specific genetic profiles. It is in the same clinical trial phase, assessing its safety and potential anti-tumor activity. The primary use is for metastatic or locally advanced PDAC. It works by modifying T-cells to target and destroy cancer cells with mutated KRAS proteins. This medication is classified as an immunotherapy.
ANOC-003
Like ANOC-001 and ANOC-002, ANOC-003 is administered as an autologous TCR-modified T-cell therapy for patients with pancreatic ductal adenocarcinoma. It is being evaluated in Phase 1/2 trials for safety and efficacy. The main therapeutic indication is for advanced PDAC. Its mechanism involves using genetically modified T-cells to attack cancer cells with specific KRAS mutations. It is part of the immunotherapy class of medications.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It is known for its aggressive nature and tendency to spread quickly to nearby organs. The disease often progresses silently, with symptoms appearing only in advanced stages. Common symptoms may include abdominal pain, weight loss, and jaundice. As the cancer grows, it can obstruct the bile duct, leading to further complications. The progression of the disease can vary, but it typically involves the local spread to surrounding tissues and distant metastasis.