A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Juno Therapeutics, a Subsidiary of Celgene

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group performance status of 0 to 1

Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function

Adequate vascular access for leukapheresis procedure

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Exclusion Criteria

Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)

Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis

Active hepatitis B or hepatitis C infection at the time of screening

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Treatment Details

Interventions

lisocabtagene maraleucel (CAR T-cell Therapy)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Lisocabtagene maraleucelExperimental Treatment1 Intervention

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of lisocabtagene maraleucel. During lisocabtagene maraleucel production, subjects may receive low-dose chemotherapy for disease control. Upon successful generation of lisocabtagene maraleucel product, subjects will receive treatment which will include lymphodepleting chemotherapy followed by one dose of lisocabtagene maraleucel administered by intravenous (IV) injection.