18 and older, any sex, with Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematopoietic Recovery (CRi), as Determined by an Independent Review Committee (IRC)Primary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
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 lumbar puncture or Ommaya reservoir tap, CNS imaging, or biopsy are performed, results must show no ev
Group
Value
95% CI
JCAR015
45.5
24.4 – 67.8
Percentage of Participants With CR or CRi, as Determined by an IRCSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
ORR is defined as the percentage of participants with CR or CRi based on IRC assessment (refer to criteria in Outcome Measure #1)
Group
Value
95% CI
JCAR015
55.6
35.3 – 74.5
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRCSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
Best overall response (BOR) is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).
CR
Group
Value
95% CI
JCAR015
8.3
CRi
Group
Value
95% CI
JCAR015
33.3
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRCSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
BOR is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).
CR
Group
Value
95% CI
JCAR015
12.5
CRi
Group
Value
95% CI
JCAR015
34.3
Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRiSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a polymerase chain reaction (PCR)-based assay.
MRD-negative CR/CRi
Group
Value
95% CI
JCAR015
41.7
MRD-positive CR/CRi
Group
Value
95% CI
JCAR015
0
MRD-negative CR/CRi unconfirmed
Group
Value
95% CI
JCAR015
12.6
MRD-positive CR/CRi unconfirmed
Group
Value
95% CI
JCAR015
4.2
Percentage of Participants Who Achieved a MRD-Negative CR or CRiSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a PCR-based assay.
MRD-negative CR/CRi
Group
Value
95% CI
JCAR015
46.9
MRD-positive CR/CRi
Group
Value
95% CI
JCAR015
0
MRD-negative CR/CRi unconfirmed
Group
Value
95% CI
JCAR015
9.4
MRD-positive CR/CRi unconfirmed
Group
Value
95% CI
JCAR015
3.1
Relapse-Free Survival (RFS), as Determined by an IRCSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to hematopoietic stem cell transplant (HSCT) after JCAR015 infusion were censored at the time of HSCT.
Group
Value
95% CI
JCAR015
6.3
1.9 – NA
RFS, as Determined by an IRCSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.
Group
Value
95% CI
JCAR015
4.4
2.1 – 9.4
Event-Free Survival (EFS)Secondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.
Group
Value
95% CI
JCAR015
0.03
0.03 – 3.8
EFSSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.
Group
Value
95% CI
JCAR015
2.7
0.03 – 4.2
Overall Survival (OS)Secondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.
Group
Value
95% CI
JCAR015
7.33
5.16 – 12.68
OSSecondary· Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.
Group
Value
95% CI
JCAR015
8.15
5.32 – 12.68
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
JCAR015
Serious: 23/38 (61%)
Deaths: 24/38
Serious adverse events (16 terms)
Reaction
System
JCAR015
Encephalopathy
Nervous system disorders
—
Cytokine release syndrome
Immune system disorders
—
Brain oedema
Nervous system disorders
—
Seizure
Nervous system disorders
—
Sepsis
Infections and infestations
—
Generalised tonic-clonic seizure
Nervous system disorders
—
Bacteraemia
Infections and infestations
—
Fungaemia
Infections and infestations
—
Neutropenic colitis
Gastrointestinal disorders
—
Asthenia
General disorders
—
Pyrexia
General disorders
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Atrial fibrillation
Cardiac disorders
—
Myocardial infarction
Cardiac disorders
—
Cholecystitis
Hepatobiliary disorders
—
Abdominal pain
Gastrointestinal disorders
—
Other adverse events (115 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Juno Therapeutics, a Subsidiary of Celgene
Last refreshed: 4 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02535364.