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# FDA Allows Juno Trial to Resume After Deaths
- URL: https://www.fdaweb.com/fda-allows-juno-trial-to-resume-after-deaths/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136176

In a positive sign for Juno Therapeutics and other developers of promising CAR-T cell product candidates, FDA has removed a clinical hold on Juno’s Phase 2 clinical trial of JCAR015 (ROCKET trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the hold on the trial after three patient deaths, two of which occurred this month after a recent addition of fludarabine to the pre-conditioning regimen.

Earlier this week, the company submitted a complete response addressing the agency’s concerns. It 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. Juno says FDA agreed to the resuming enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

Novartis and Kite Pharmaceuticals are also developing CAR-T cell therapies that look to genetically engineer a patient’s own T-cells to help fight diseases.