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Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

Active: No
Cancer Type: Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary 		NCT ID: NCT02631044
Trial Phases: Phase I Protocol IDs: 017001 (primary)
NCI-2016-00057
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Juno Therapeutics, a Subsidiary of Celgene
NCI Full Details: http://clinicaltrials.gov/show/NCT02631044

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

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