Phase 2
N=113
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT03484702 ↗Enrolled (actual)
113
Serious AEs
28.3%
Results posted
Dec 2024
Primary outcome: Primary: Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 — 61.1; 63.0; 70.0 Percent of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JCAR017 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 |
61.1; 63.0; 70.0 | — |
| PRIMARY Overall Response Rate (ORR) Per Investigator in Cohort 4 |
100 | — |
| PRIMARY Overall Response Rate (ORR) Per Investigator in Cohort 5 |
80.0 | — |
| PRIMARY Number of Participants With Adverse Events in Cohort 7 |
0; 2; 9; 7; 7 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 |
0; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 |
0; 2; 5; 0; 1 | — |
| PRIMARY Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 |
5; 5; 0; 0; 0; 29 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 |
4; 2; 1; 0; 1; 11 | — |
| SECONDARY Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Overall Response Rate (ORR) in Cohort 7 |
88.9 | — |
| SECONDARY Complete Response Rate (CRR) |
33.3; 48.1; 50.0; 0; 0; 88.9 | — |
| SECONDARY Event Free Survival (EFS) |
2.99; 3.12; 6.33; 23.95; 14.23; NA | — |
| SECONDARY Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria |
2.99; 3.12; 6.33; 14.23; 23.95; NA | — |
| SECONDARY Overall Survival (OS) |
15.84; 16.82; 14.72; 31.74; 14.23; NA | — |
| SECONDARY Duration of Response (DOR) |
3.83; 3.91; 9.07; 17.97; 17.63; NA | — |
| SECONDARY Maximum Concentration (Cmax) of JCAR017 by qPCR |
23132.1; 21960.0; 17337.8; 51121.0; 7661.6; 32027.1 | — |
| SECONDARY Time to Peak Concentration (Tmax) of JCAR017 by qPCR |
11.6; 9.0; 84.1; 10.0; 9.0; 12.2 | — |
| SECONDARY Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR |
185586.667; 157499.362; 134819.085; 286119.439; 64945.715; 199731.737 | — |
| SECONDARY Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR |
88.2; 95.2; 100.0; 100.0; 80.0; 100.0 | — |
| SECONDARY Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores |
-4.41; -5.07; -6.67; -8.33; 8.33; -7.41 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores |
0.7; 0.1; 1.9; 1.0; -4.0; -1.2 | — |
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)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03484702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.