CompletedPhase 2

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

Austria, Belgium, Finland113 participantsStarted 2018-06-05

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological confirmation of diagnosis at last relapse * Adequate organ function * Adequate vascular access for leukapheresis procedure Exclusion Criteria: * Prior history of malignancies, other than aggressive relapsed/refractory Non-Hodgkin Lymphoma, unless the participant has been in remission for ≥ 2 years with the exception of non-invasive malignancies * Received previous CD19-targeted therapy * Progressive vascular tumor invasion, thrombosis, or embolism Other protocol-defined inclusion/exclusion criteria apply

What they're measuring

Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3

Timeframe: 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) Per Investigator in Cohort 4

Timeframe: 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) Per Investigator in Cohort 5

Timeframe: 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)

Number of Participants With Adverse Events in Cohort 7

Timeframe: From leukapheresis to end of study (up to approximately 63 months)

Number of Participants With Serious Adverse Events (SAEs) in Cohort 7

Timeframe: From leukapheresis to end of study (up to approximately 63 months)

Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7

Timeframe: At Baseline and Day 29 after JCAR017 infusion

Trial details

NCT IDNCT03484702

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-15

Results submitted2024-11-21

View on ClinicalTrials.gov More Lymphoma, Non-Hodgkin trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3

Timeframe: 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) Per Investigator in Cohort 4

Timeframe: 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) Per Investigator in Cohort 5

Timeframe: 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)

Number of Participants With Adverse Events in Cohort 7

Timeframe: From leukapheresis to end of study (up to approximately 63 months)

Number of Participants With Serious Adverse Events (SAEs) in Cohort 7

Timeframe: From leukapheresis to end of study (up to approximately 63 months)

Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7

Timeframe: At Baseline and Day 29 after JCAR017 infusion