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NCT02535364 · ClinicalTrials.gov registry record · Phase 2

Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL)

A Phase 2 study, sponsored by Juno Therapeutics, a Subsidiary of Celgene.

Terminated
Registry status
Phase 2
Development phase
82
Enrollment target

NCT02535364: Clinical Trial Phase 2 study, sponsored by Juno Therapeutics, a Subsidiary of Celgene.

NCT02535364 is a Phase 2 study that was terminated before completion, run by Juno Therapeutics, a Subsidiary of Celgene. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02535364, a Phase 2 study, was terminated before completion, sponsored by Juno Therapeutics, a Subsidiary of Celgene.

TERMINATED
Registry status
Phase 2
Development phase
82 participants
Enrollment target

Study Summary

This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that express the CD19 protein on the cell surface. The study will determine if these modified T cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this treatment on survival.

Primary Outcome

Overall remission rate (ORR) is defined as the percentage of participants with CR or CRi based on IRC assessment. For CR, all of the following must be met: (1) in bone marrow, trilineage hematopoiesis and \< 5% blasts; (2) in peripheral blood, neutrophils \> 1,000/µL, platelets \> 100,000/µL, and circulating blasts \< 1%; (3) no clinical evidence of extramedullary disease by physical examination and no symptoms suggestive of CNS involvement (if additional assessments such as CSF assessment by lu

Interventions

  • BIOLOGICAL JCAR015 (CD19-targeted CAR T cells)

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2015-08-21
Est. Completion 2017-09-01
Phase Phase 2

Why NCT02535364 stopped before completion

NCT02535364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 1 intervention - of which JCAR015 (CD19-targeted CAR T cells) is the first listed.

NCT02535364 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02535364 about?

NCT02535364 is a clinical study titled "Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL)". This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that express the CD19 protein on ...

What is the current status of trial NCT02535364?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2015-08-21. Estimated completion is 2017-09-01.

What interventions are being tested in trial NCT02535364?

The interventions under investigation include: JCAR015 (CD19-targeted CAR T cells) (BIOLOGICAL).

Who is sponsoring clinical trial NCT02535364?

This trial is sponsored by Juno Therapeutics, a Subsidiary of Celgene, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02535364's enrollment target sits among peer trials

82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02535364, the US trial registry maintained by the National Library of Medicine. NCT02535364 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.