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A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R / R) B-cell Non-Hodgkin Lymphoma (NHL)

Status
Active
Cancer Type
Lymphoma
Non-Hodgkin Lymphoma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT02631044
Protocol IDs
017001 (primary)
NCI-2016-00057
Study Sponsor
Juno Therapeutics, Inc.

Summary

This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment.

Objectives

This is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics (PK), and antitumor activity of JCAR017 in adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma Grade 3B, and mantle cell lymphoma (MCL). This study will evaluate and refine the dose and schedule of JCAR017 to optimize safety and antitumor activity. A dose-confirmation group or groups will further evaluate the safety and efficacy of JCAR017 at the recommended regimen(s). Upon successful generation of JCAR017 product, participants will receive treatment with one or more cycles of JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one or two doses of JCAR017 administered by intravenous (IV) injection. The follow-up period for each participant is approximately 24 months after the final JCAR017 infusion. Long-term follow-up for survival, toxicity, and viral vector safety will continue under a separate long-term follow-up protocol per health regulatory authority guidelines, currently up to 15 years after the last JCAR017 infusion.

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:
Stacey Brown
404-780-7965

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD
Melhem Solh MD
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