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# Juno Sends Complete Response for JCAR015 Clinical Hold
- URL: https://www.fdaweb.com/juno-sends-complete-response-for-jcar015-clinical-hold/
- Published: 2016-07-12T12:00:00.000Z
- Updated: 2026-09-14T21:13:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136153

Juno Therapeutics has submitted a complete response to FDA to address concerns after a clinical hold was ordered on a Phase 2 clinical trial (ROCKET) involving JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the hold on the trila after three patient deaths, with two occurring this month after a recent addition of fludarabine to the pre-conditioning regimen. Juno says it has proposed to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. The complete response included a revised patient informed consent form, a revised investigator brochure, and a revised trial protocol. Juno says its trials and plans for other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected.