Trial · NCT03484702

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma

NCT03484702, Phase 2, Completed, Celgene; results first posted 2024-12-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma. Trials, record NCT03484702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03484702

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
NCT number: NCT03484702
Status: Completed
Phases: Phase 2
Enrollment: 113 participants, actual
Lead sponsor: Celgene
Conditions: Lymphoma, Non-Hodgkin
Interventions: JCAR017
First posted: 2018-04-02
Last updated: 2024-12-27
Other registries' IDs: eudract:2017-000106-38
Results first posted: 2024-12-27

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3	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 nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: No * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: No * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Primary	Overall Response Rate (ORR) Per Investigator in Cohort 4	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 baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Primary	Overall Response Rate (ORR) Per Investigator in Cohort 5	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 * Cerebrospinal fluid cytology: Negative Partial response (PR): * Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement. * Corticosteroid dose: Irrelevant * Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate. * Cerebrospinal fluid cytology: Negative, persistent or suspicious
Primary	Number of Participants With Adverse Events in Cohort 7	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, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Primary	Number of Participants With Serious Adverse Events (SAEs) in Cohort 7	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; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Primary	Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7	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).
Primary	Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7	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).
Secondary	Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5	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, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Secondary	Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5	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; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Secondary	Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5	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.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3	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)	All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1,2, and 3 only.	Percent of Participants	NUMBER
PRIMARY	Overall Response Rate (ORR) Per Investigator in Cohort 4	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)	All participants in the JCAR017 treated set. Prespecified to be reported for cohort 4 only.	Percent of Participants	NUMBER
PRIMARY	Overall Response Rate (ORR) Per Investigator in Cohort 5	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)	All participants in the JCAR017 treated set. Prespecified to be reported for cohort 5 only.	Percent of Participants	NUMBER
PRIMARY	Number of Participants With Adverse Events in Cohort 7	From leukapheresis to end of study (up to approximately 63 months)	All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Serious Adverse Events (SAEs) in Cohort 7	From leukapheresis to end of study (up to approximately 63 months)	All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7	At Baseline and Day 29 after JCAR017 infusion	All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohort 7 only	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7	At Baseline and Day 29 after JCAR017 infusion	All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5	From leukapheresis to end of study (up to approximately 63 months)	All participants in the JCAR017 treated set. Prespecified to be reported for Cohorts 1, 2, 3, 4, and 5 only	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5	From leukapheresis to end of study (up to approximately 63 months)	All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5	At Baseline and Day 29 after JCAR017 infusion	All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 23Source ClinicalTrials.gov

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Results by group516

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3	Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy		61.1	95% Confidence Interval 43.5 to 76.9	Percent of Participants
Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3	Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy		63.0	95% Confidence Interval 42.4 to 80.6	Percent of Participants
Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3	Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2		70.0	95% Confidence Interval 34.8 to 93.3	Percent of Participants
Overall Response Rate (ORR) Per Investigator in Cohort 4	Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma		100	95% Confidence Interval 100 to 100	Percent of Participants
Overall Response Rate (ORR) Per Investigator in Cohort 5	Cohort 5: Primary Central Nervous System Lymphoma		80.0	95% Confidence Interval 28.4 to 99.5	Percent of Participants
Number of Participants With Adverse Events in Cohort 7	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)	0		Participants
Number of Participants With Adverse Events in Cohort 7	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	AEs occurring between LDC and JCAR017 infusion	2		Participants
Number of Participants With Adverse Events in Cohort 7	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	AEs occurring between JCAR017 infusion and Day 30	9		Participants
Number of Participants With Adverse Events in Cohort 7	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	AEs occurring between Day 31 and Day 90	7		Participants
Number of Participants With Adverse Events in Cohort 7	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	AEs occurring between Day 91 and end of study	7		Participants

1 to 10 of 516Source ClinicalTrials.gov

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Participant flow42

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-Treatment Period - Leukapheresis	STARTED	Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy	45
Pre-Treatment Period - Leukapheresis	STARTED	Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy	32
Pre-Treatment Period - Leukapheresis	STARTED	Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2	14
Pre-Treatment Period - Leukapheresis	STARTED	Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma	4
Pre-Treatment Period - Leukapheresis	STARTED	Cohort 5: Primary Central Nervous System Lymphoma	7
Pre-Treatment Period - Leukapheresis	STARTED	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	11
Pre-Treatment Period - Leukapheresis	COMPLETED	Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy	43
Pre-Treatment Period - Leukapheresis	COMPLETED	Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy	27
Pre-Treatment Period - Leukapheresis	COMPLETED	Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2	12
Pre-Treatment Period - Leukapheresis	COMPLETED	Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma	1

1 to 10 of 42Source ClinicalTrials.gov

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Adverse events666

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Acquired antithrombin III deficiency	Blood and lymphatic system disorders	Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy	0	45
other	Acquired antithrombin III deficiency	Blood and lymphatic system disorders	Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy	0	32
other	Acquired antithrombin III deficiency	Blood and lymphatic system disorders	Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2	1	14
other	Acquired antithrombin III deficiency	Blood and lymphatic system disorders	Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma	0	4
other	Acquired antithrombin III deficiency	Blood and lymphatic system disorders	Cohort 5: Primary Central Nervous System Lymphoma	0	7
other	Acquired antithrombin III deficiency	Blood and lymphatic system disorders	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	0	11
other	Anaemia	Blood and lymphatic system disorders	Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy	21	45
other	Anaemia	Blood and lymphatic system disorders	Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy	8	32
other	Anaemia	Blood and lymphatic system disorders	Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2	10	14
other	Anaemia	Blood and lymphatic system disorders	Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma	0	4

1 to 10 of 666Source ClinicalTrials.gov

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Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy	32	45
Total, all-cause mortality	Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy	22	32
Total, all-cause mortality	Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2	9	14
Total, all-cause mortality	Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma	0	4
Total, all-cause mortality	Cohort 5: Primary Central Nervous System Lymphoma	5	7
Total, all-cause mortality	Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting	4	11
Total, other adverse events	Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy	40	45
Total, other adverse events	Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy	25	32
Total, other adverse events	Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2	12	14
Total, other adverse events	Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma	1	4

1 to 10 of 18Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34515338	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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