18 and older, any sex, with Lymphoma, Non-Hodgkin. 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.
Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3Primary· From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR).
Complete response via PET-CT:
* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale
* New lesions: No
* Bone marrow: No FDG-avid disease
Complete response via CT scan:
* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.
* Nonmeasured lesion: No
* New lesions: No
* Bone marrow: Normal
Partial response via PET-CT:
* Lymph no
Group
Value
95% CI
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
61.1
43.5 – 76.9
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
63.0
42.4 – 80.6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
70.0
34.8 – 93.3
Overall Response Rate (ORR) Per Investigator in Cohort 4Primary· From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR).
Complete response via PET-CT:
* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale
* New lesions: No
* Bone marrow: No FDG-avid disease
Complete response via CT scan:
* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.
* Nonmeasured lesion: None
* New lesions: No
* Bone marrow: Normal
Partial response via PET-CT:
* Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from
Overall Response Rate (ORR) Per Investigator in Cohort 5Primary· From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR).
Complete response (CR):
* Brain imaging: No contrast enhancement
* Corticosteroid dose: None
* Eye examination: Normal
* Cerebrospinal fluid cytology: Negative
Complete response unconfirmed (CRu):
* Brain imaging: No contrast enhancement, Minimal abnormality
* Corticosteroid dose: Any
* Eye examination: Normal, minor RPE abnormality
* C
Group
Value
95% CI
Cohort 5: Primary Central Nervous System Lymphoma
80.0
28.4 – 99.5
Number of Participants With Adverse Events in Cohort 7Primary· From leukapheresis to end of study (up to approximately 63 months)
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate,
AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
AEs occurring between LDC and JCAR017 infusion
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
2
AEs occurring between JCAR017 infusion and Day 30
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
9
AEs occurring between Day 31 and Day 90
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
7
AEs occurring between Day 91 and end of study
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
7
Number of Participants With Serious Adverse Events (SAEs) in Cohort 7Primary· From leukapheresis to end of study (up to approximately 63 months)
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:
* Results in death;
* Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE);
* Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay).
* Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);
* Is a congenital anomaly/birth defect;
* C
SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
SAEs occurring between LDC and JCAR017 infusion
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
SAEs occurring between JCAR017 infusion and Day 30
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
1
SAEs occurring between Day 31 and Day 90
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
SAEs occurring between Day 91 and end of study
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
1
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7Primary· At Baseline and Day 29 after JCAR017 infusion
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Leukocytes (10^9/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
Neutrophils, Segmented (10^9/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
2
Platelets (10^9/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
5
Activated Partial Thromboplastin Time (sec) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
Prothrombin Intl. Normalized Ratio - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
1
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7Primary· At Baseline and Day 29 after JCAR017 infusion
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Albumin (g/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
Phosphate (mmol/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
Alkaline Phosphatase (U/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
Alanine Aminotransferase (U/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
Aspartate Aminotransferase (U/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
1
Bilirubin (umol/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
0
Creatinine (umol/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
7
Triglycerides (mmol/L) - Day 29
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
3
Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5Secondary· From leukapheresis to end of study (up to approximately 63 months)
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate,
AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
Group
Value
95% CI
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
5
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
5
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5Secondary· From leukapheresis to end of study (up to approximately 63 months)
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:
* Results in death;
* Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE);
* Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay).
* Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);
* Is a congenital anomaly/birth defect;
* C
SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
Group
Value
95% CI
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
0
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
1
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5Secondary· At Baseline and Day 29 after JCAR017 infusion
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
Leukocytes (10^9/L) - Day 29
Group
Value
95% CI
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
4
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
2
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5Secondary· At Baseline and Day 29 after JCAR017 infusion
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
Albumin (g/L) - Day 29
Group
Value
95% CI
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
0
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
0
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
Overall Response Rate (ORR) in Cohort 7Secondary· From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR).
Complete response via PET-CT:
* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale
* New lesions: No
* Bone marrow: No FDG-avid disease
Complete response via CT scan:
* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.
* Nonmeasured lesion: None
* New lesions: No
* Bone marrow: Normal
Partial response via PET-CT:
* Lymph nodes/extralymphatic: Score 4, 5b, reduced
Group
Value
95% CI
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
88.9
51.8 – 99.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
Serious: 19/45 (42%)
Deaths: 32/45
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
Serious: 8/32 (25%)
Deaths: 22/32
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
NCT04245839 — A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non
· Phase 2
· active not recruiting
NCT03575351 — A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-e
· Phase 3
· completed
NCT03743246 — A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute
· Phase 1, PHASE2
· terminated
NCT03436771 — Long-term Follow-up Study for Patients Previously Treated With a Juno CAR T-Cell Product
· terminated
NCT03310619 — A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies
· Phase 1, PHASE2
· completed
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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 Celgene
Last refreshed: 27 December 2024
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/NCT03484702.