Active not recruitingPHASE2INTERVENTIONAL

Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

This research study, called Spearhead 1, is investigating a new treatment named afamitresgene autoleucel (previously known as ADP-A2M4). It's for people in the UK whose synovial sarcoma or myxoid liposarcoma has advanced, meaning it has spread or can't be removed by surgery. The treatment is being tested in individuals who have certain genetic markers (HLA-A*02 and MAGE-A4 positive). The main goals are to find out how effective this treatment is at shrinking tumours and controlling the disease, as well as to check for any side effects and how safe it is overall. It's a Phase 2 study, which means it’s still in the earlier stages of testing new treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

USWM CT, LLC

Enrolment target

Start

13 Aug 2019

Estimated completion

01 Apr 2038

Synovial Sarcoma Myxoid Liposarcoma

What is this study about?

This clinical trial, known as the Spearhead 1 Study, is exploring a new and innovative treatment for two specific types of soft tissue cancer: advanced synovial sarcoma and myxoid/round cell liposarcoma. These cancers are considered 'advanced' when they have spread to other parts of the body (metastatic) or cannot be removed through surgery.

The experimental treatment being tested is called afamitresgene autoleucel. It's a type of immunotherapy, which means it works by helping your body's own immune system fight the cancer. For this treatment to be considered, patients must have specific characteristics in their genes, known as HLA-A*02 types, and their cancer cells must show a particular marker called MAGE-A4. These markers help identify who might benefit most from this targeted therapy.

The main purpose of this study is to see how well afamitresgene autoleucel works in shrinking tumours and controlling the disease, and importantly, to understand its safety. It's a Phase 2 study, meaning it’s a crucial step in understanding if this new approach could eventually become a standard treatment option for these challenging cancers.

Key takeaways

This study is for advanced synovial sarcoma or myxoid liposarcoma.
It tests an experimental immune cell therapy called afamitresgene autoleucel.
Specific genetic markers (HLA-A*02 and MAGE-A4) are required for eligibility.
It's a Phase 2 trial, focused on safety and how well the treatment works.
Participation involves screening, treatment, and regular follow-up visits.

Who may be eligible?

To join this study, people generally need to be between 16 and 75 years old, although some specific sites may include patients as young as 10 years old. You must have an advanced form of synovial sarcoma or myxoid liposarcoma that has been confirmed by genetic tests. Importantly, your cancer must have previously been treated with certain chemotherapy drugs (like anthracycline or ifosfamide).

Additionally, your cancer must be measurable, and your body tissues need to have specific genetic markers – HLA-A*02 and MAGE-A4 – which will be checked. Your overall health and fitness, as measured by something called an ECOG Performance Status or Lansky Score for younger participants, also needs to be at a good level, and your heart function should be healthy.

There are also reasons why someone might not be able to join the study. For example, if you have a certain type of HLA-A*02 marker (HLA-A*02:05), if you have recently received other anti-cancer treatments (like chemotherapy, certain targeted therapies, or immunotherapy), or if you have a history of serious allergic reactions to study drugs. People with certain autoimmune conditions, active cancer spread to the brain, or other active cancers may also be excluded. The study team will review all specific criteria carefully with you.

Quick self-check

Are you between 10 (at specific sites) and 75 years old?
Do you have advanced synovial sarcoma or myxoid liposarcoma?
Have you previously received specific chemotherapy treatments?
Are you generally in good health with a healthy heart function?
Do you have certain genetic markers (HLA-A*02 and MAGE-A4)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first undergo several tests to confirm your eligibility, including blood tests, genetic testing of your tumour, and scans. If eligible, you would likely have a procedure called 'leukapheresis' to collect your immune cells.

Following this, you would receive a short course of chemotherapy to prepare your body for the new treatment. Then, the modified immune cells (afamitresgene autoleucel) would be given to you as an infusion. You'll need to stay in the hospital for some time after the infusion for close monitoring. After discharge, you will have regular follow-up visits, which include blood tests, physical examinations, and scans, to check how you are responding to the treatment and to monitor for any side effects. The total duration of participation, including treatment and follow-up, can vary but typically involves regular assessments over many months.

Potential risks and benefits

Participating in a clinical trial like this means you will be receiving an experimental treatment, which may or may not help your condition. A potential benefit could be that the treatment might shrink your tumour or slow down the cancer's growth, potentially improving your quality of life. However, like all medications, it also carries potential risks of side effects, some of which could be serious. The study doctors will carefully monitor you for any adverse reactions throughout your participation. You will be given a detailed explanation of all potential risks before you decide to join. It is very important to remember that participating in a clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

City of Hope
Duarte, United States
Stanford Cancer Center
Palo Alto, United States
University of Colorado
Aurora, United States
Mayo Clinic Jacksonville
Jacksonville, United States
Moffitt Cancer Center
Tampa, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, United States
National Cancer Institute
Bethesda, United States
Massachusetts General Hospital
Boston, United States
Dana Farber Cancer Institute
Boston, United States
University of Michigan
Ann Arbor, United States
Washington University School of Medicine
St Louis, United States
Memorial Sloan-Kettering Cancer Center
New York, United States

+14 more sites — see the official record for the full list.

Common questions

What is synovial sarcoma or myxoid liposarcoma?

These are rare types of cancer that start in the soft tissues of the body, such as muscles, fat, ligaments, or nerves.

What is afamitresgene autoleucel?

It's an experimental treatment where your own immune cells are specially modified in the lab to help them fight your cancer.

What are HLA-A*02 and MAGE-A4 types?

These are genetic markers found in your body and on your cancer cells that tell us if this specific treatment might work for you.

Is this a new treatment?

Yes, this treatment is still in the research phase (Phase 2), meaning it's being tested to see how effective and safe it is before it can be widely available.

Can I continue my other cancer treatments if I join?

Generally no, you would need to stop most other cancer treatments before joining this study, but the study team will discuss all restrictions with you.