GCAR1 for Alveolar Soft Part Sarcoma

MS
Overseen ByMona Shafey
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: AHS Cancer Control Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with progressive metastatic alveolar soft part sarcoma (ASPS), a rare cancer. The treatment, called GCAR1, personalizes therapy by modifying a patient's immune cells to target and attack cancer cells. It is intended for those with no remaining treatment options. Suitable candidates for this trial include individuals with ASPS who have healthy organ function and no active infections. As an Early Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that GCAR1 is likely to be safe for humans?

Previous studies have tested GCAR1 for safety in treating alveolar soft part sarcoma (ASPS), a specific type of cancer. This treatment employs a unique cell therapy that targets cancer cells. Research indicates that this method specifically attacks cancer cells, potentially protecting healthy cells.

Although detailed safety data from these studies is not widely available, testing GCAR1 in humans suggests some evidence of safety. Early trials often focus on safety. Additionally, GCAR1 is tailored to each person, which can sometimes reduce the risk of side effects. However, as this is an early-stage trial, understanding its full safety profile remains ongoing. Participants should stay informed and discuss any concerns with their healthcare providers.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Alveolar Soft Part Sarcoma, which often include surgery, radiation, and chemotherapy, GCAR1 offers a novel approach by using a patient-specific cell therapy. This treatment harnesses the power of autologous lymphocytes that are genetically modified with a chimeric antigen receptor (CAR) to specifically target tumor cells expressing the protein GPNMB. Researchers are excited because this targeted approach could potentially improve precision in attacking cancer cells while sparing healthy tissues, offering a promising new avenue for patients with this rare cancer.

What evidence suggests that GCAR1 might be an effective treatment for alveolar soft part sarcoma?

Research has shown that GCAR1 could be a promising treatment for alveolar soft part sarcoma (ASPS). This therapy uses a type of immune cell modified to attack cancer cells with a specific protein called GPNMB. Similar treatments have demonstrated that targeting specific proteins on cancer cells can be effective. For instance, some treatments have helped 35% of patients with advanced sarcoma by shrinking the cancer or stopping its growth. Although direct data on GCAR1's effectiveness is limited, its design suggests potential benefits for ASPS patients.14678

Are You a Good Fit for This Trial?

This trial is for a single patient with advanced alveolar soft part sarcoma that has spread and no other treatment options left. The patient must have good kidney and heart function, and be able to give informed consent.

Inclusion Criteria

I have signed the Informed Consent Form.
My kidneys and heart are working well enough for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patient receives GCAR1 T-cell therapy targeting tumor cells expressing GPNMB

4-6 weeks
1 visit (in-person) for infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Regular imaging (CT/MRI) every 4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GCAR1

Trial Overview

The study tests GCAR1, a personalized cell therapy made from the patient's own immune cells, which are modified to target cancer cells showing the GPNMB protein. This is a one-patient compassionate use study.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: GCAR1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials
188
Recruited
26,900+

Citations

CAR T Therapy With GCAR1 for Relapsed Alveolar Soft ...

A single patient study to determine whether GCAR1 is safe and effective for re-treatment of alveolar soft part sarcoma (ASPS) with GPNMB surface expression that ...

Review of Adoptive Cellular Therapies for the Treatment of ...

The estimated overall 3-year survival for sarcoma was found to be 38%, and 5-year survival was 14%. D'Angelo et al. later reported on a pilot ...

NCT07104682 | A Study to Determine the Safety and ...

A single patient study to determine whether GCAR1 is safe and effective for refractory, progressive metastatic alveolar soft part sarcoma (ASPS). Detailed ...

Advances in alveolar soft part sarcoma treatment in the era ...

This review summarizes and discusses recent advances in ASPS treatment, focusing on the role of immunotherapy.

GCAR1 for Sarcoma · Info for Participants

This trial explores a new treatment called GCAR1 for alveolar soft part sarcoma (ASPS). The goal is to determine if GCAR1 is safe and effective for patients ...

A Study to Determine the Safety and Effectiveness of the ...

A single patient study to determine whether GCAR1 is safe and effective for refractory, progressive metastatic alveolar soft part sarcoma ...

GCAR1 Therapy for Metastatic Alveolar Soft Part Sarcoma

The study does not specify immediate outcomes, but the focus is on evaluating whether this targeted cell therapy can effectively combat the cancer, offering ...

Recent progress in the clinicopathological characteristics of ...

However, they also reported that the 5-year survival rate in children was about 95%, higher than that of adults (85%). ASPS exhibits slow growth ...