GCAR1 for ASPS

(CLIC-YYC-GPNMB Trial)

Age: Any Age

Sex: Male

Trial Phase: Phase < 1

Sponsor: University of Calgary

Must not be taking: Anti-cancer therapy

Disqualifiers: Uncontrolled infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 46

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for someone with a rare cancer called Alveolar Soft Part Sarcoma that has come back and can't be removed by surgery without serious risk. They must understand the study and agree to participate, have good kidney function (creatinine clearance >30 ml/min), and a healthy heart (LVEF >45%). People who've had cancer treatment in the last 21 days or have an uncontrolled infection cannot join.

Inclusion Criteria

The patient must provide informed consent

My ASPS has returned and cannot be surgically removed without major risk.

My kidneys and heart are functioning well.

Exclusion Criteria

I haven't had any cancer treatment in the last 21 days.

I do not have any ongoing infections that aren't being treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Standard lymphodepleting chemotherapy with Fludarabine and Cyclophosphamide prior to GCAR1 infusion

5 days

Treatment

First infusion of GCAR1, a patient-specific cell therapy product

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment with diagnostic imaging

12 months

Imaging at day 46, day 91, 6 months, 9 months, and 12 months post-infusion

Second Infusion (Optional)

Second infusion of GCAR1 may be administered based on disease response and physician discretion

60 to 730 days post first infusion

What Are the Treatments Tested in This Trial?

Interventions

• GCAR1

Trial Overview The trial is testing GCAR1, an investigational cellular therapy, on one patient with ASPS that's spread and not responding to other treatments. It aims to find out if GCAR1 is safe and works against this type of sarcoma.

How Is the Trial Designed?

Group I: GCAR1 Experimental Treatment 1 Intervention

The patient may receive two separate intravenous infusions of cryopreserved, autologous GCAR1, each containing a total of 5.0E6 CAR+ T cells/kg patient body weight. Both infusions will be preceded by standard lymphodepleting chemotherapy (Fludarabine 40 mg/m2 x 3 days, cyclophosphamide 600 mg/m2 x 2 days). The patient will only be eligible to receive a second dose if they had a partial response (PR), stable, or progressive disease (SD/PD) by RECIST 1.1 criteria after receiving Dose 1. A second infusion should not be administered if the patient achieves and sustains a complete response on disease assessment. Dose 2 will be administered at physician discretion and must be given at minimum 60 days and a maximum of 730 days post administration of Dose 1. For the patient to proceed with a second infusion, any toxicity that does not meet the criteria of a Dose Limiting Toxicity must be assessed for clinical significance, and taken into consideration by the PI before proceeding.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+