GCAR1 for Sarcoma

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?

a single patient study to answer the following question: Is GCAR1 safe and effective for re-treatment of alveolar soft part sarcoma (ASPS) with GPNMB surface expression that has relapsed and is not responding to usual treatment?

Eligibility Criteria

This trial is for patients with a rare cancer called Alveolar Soft Part Sarcoma (ASPS) that has come back after treatment. They must be healthy enough in terms of kidney function and heart strength, not have active infections, and can't be pregnant or breastfeeding. Also, they should not have had any cancer treatments in the last 3 weeks.

Inclusion Criteria

The patient must provide informed consent

My kidneys and heart are functioning well.

Exclusion Criteria

I do not have any ongoing infections that aren't under control.

Pregnancy or nursing

I haven't had cancer treatment in the last 3 weeks.

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Treatment Details

Interventions

GCAR1 (CAR T-cell Therapy)

Trial OverviewThe study is testing GCAR1, a CAR T therapy designed to target ASPS cells that show GPNMB on their surface. It's an experimental approach being tried out on one patient to see if it's safe and works better than current treatments for this relapsed cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GCAR1Experimental Treatment1 Intervention

Lymphodepleting Chemotherapy Regimen Day Medication Dose * 4 Fludarabine\*\* 40 mg/m2 * 3 Fludarabine\*\* Cyclophosphamide\*\* 40 mg/m2 600 mg/m2 * 2 Fludarabine\*\* Cyclophosphamide\*\* 40 mg/m2 600 mg/m2 * 1 REST DAY 1. GCAR1 See below \*\* Please refer to institutional guidelines for administration of these products. Pre and post hydration requirements, infusion time and any supportive medications will follow institutional standard of care. Infusion number GCAR1 Dose (CAR+ T cells/kg) 1. 5 x 106 2. 2.5 x 107 Table 2. GCAR1 Intra-patient Dose Escalation Strategy