NCT03060356

Autologous T Cells Expressing MET scFv CAR (RNA CART-cMET)

Clinical Trial of Autologous cMET Redirected T Cells Administered Intravenously in Patients With Melanoma & Breast Carcinoma

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to evaluate feasibility, safety, and preliminary evidence of efficacy for intravenously administered, RNA electroporated autologous T cells expressing MET chimeric antigen receptors with tandem TCRζ and 4-1BB (TCRζ /4-1BB) co-stimulatory domains (referred to as "RNA CART-cMET") in patients with advanced melanoma or breast carcinoma.

Detailed description

This is a pilot study to evaluate feasibility, safety, and preliminary evidence of efficacy for intravenously administered, RNA electroporated autologous T cells expressing MET chimeric antigen receptors with tandem TCRζ and 4-1BB (TCRζ /4-1BB) co-stimulatory domains (referred to as "RNA CART-cMET") in patients with advanced melanoma or breast carcinoma. Subjects will be treated with IV administration of the RNA transduced anti-cMET CAR T cells for a total of up to six doses over a 2 week period. Each dose is 1x108 total T cells modified with RNA anti-cMET CAR. All subjects in both the melanoma and breast carcinoma arms will receive up to 6 doses of RNA CART-cMET cells, with no lymphodepleting chemotherapy administered prior to cell infusion Cell numbers are based on total cells with a portion of them having CAR expression depending on transduction efficiency and determined by flow cytometry Based on the product release criteria, at least 20% of the total cells will express the anti-cMET CAR. Treatment limiting toxicity (TLT). Adverse event reporting will begin at the start of the first dose of RNA CART-cMET and will continue until 4 months after the first infusion, or until another alternative therapy is initiated, whichever occurs earlier. Subjects will be continually reassessed for evidence of acute and cumulative toxicity.

Conditions

• Malignant Melanoma
• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	T cells modified with RNA anti -cMET CAR	Intravenously administered, RNA electroporated autologous T cells expressing MET chimeric antigen receptors with tandem TCRζ and 4-1BB (TCRζ /4-1BB) co-stimulatory domains

Timeline

• Start date: 2016-12-21
• Primary completion: 2020-03-27
• Completion: 2020-03-27
• First posted: 2017-02-23
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study