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# Juno Setback on CAR-T Cell Product After Another Trial Mishap
- URL: https://www.fdaweb.com/juno-setback-on-car-t-cell-product-after-another-trial-mishap/
- Published: 2016-11-23T12:00:00.000Z
- Updated: 2026-09-14T21:50:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137413

Juno Therapeutics is facing another setback on pushing its CAR-T cell product candidate through the development process after the company placed its ROCKET trial on clinical hold following cerebral edema reported in two patients earlier this week. One patient died and the other is not expected to recover. In July, Juno overcame another clinical hold after three patient deaths ([see story](https://www.fdaweb.com/fda-allows-juno-trial-to-resume-after-deaths/)).

The Phase 2 ROCKET trial involves adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. Juno says trials and plans for its other CD19-directed CAR T cell product candidates, including JCAR017, are not affected by the current hold. Juno has notified FDA and is working with the agency and the study’s data and safety monitoring board to determine next steps. “The company is assessing data from the cases and the trial and is evaluating its options regarding the JCAR015 program,” it says.

  
In the July hold, two deaths occurred after addition of fludarabine to the pre-conditioning regimen. FDA allowed the trial to resume after the company revised the patient informed consent form, investigator brochure and trial protocol (cyclophosphamide pre-conditioning only).