Phase 2
N=105
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Relapsed/Refractory Mantle Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02601313 ↗Enrolled (actual)
105
Serious AEs
70.4%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1 — 91 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brexucabtagene autoleucel (Biological); Cyclophosphamide (Drug); Fludarabine (Drug); Axicabtagene Ciloleucel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kite, A Gilead Company
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1 |
91 | — |
| PRIMARY Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2 |
93 | — |
| SECONDARY Duration of Response (DOR) in Cohort 1 as Per Investigator Response |
36.5 | — |
| SECONDARY Duration of Response (DOR) in Cohort 2 as Per Investigator Response |
57.5 | — |
| SECONDARY Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1 |
67.6; 20.6; 8.8; 2.9 | — |
| SECONDARY Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2 |
64.3; 21.4; 7.1; 7.1 | — |
| SECONDARY Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1 |
88 | — |
| SECONDARY Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2 |
86 | — |
| SECONDARY Progression Free Survival (PFS) in Cohort 1 as Per Investigator Response. |
25.3 | — |
| SECONDARY Progression Free Survival (PFS) in Cohort 2 as Per Investigator Response. |
29.5 | — |
| SECONDARY Overall Survival in Cohort 1 |
46.5 | — |
| SECONDARY Overall Survival in Cohort 2 |
NA | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) |
100; 100 | — |
| SECONDARY Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade |
55.9; 57.1; 98.5; 100; 61.8; 78.6 | — |
| SECONDARY Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade |
1.5; 0; 1.5; 0 | — |
| SECONDARY Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade |
10.3; 7.1; 17.6; 35.7; 0; 0 | — |
| SECONDARY Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade |
0; 0; 0; 0; 2.9; 7.1 | — |
| SECONDARY Percentage of Participants With Anti-CD19 CAR Antibodies |
21; 21 | — |
| SECONDARY Maximum Number of CAR T Cells Measured Post-infusion |
313.02; 96.69 | — |
| SECONDARY Peak Serum Levels of C-Reactive Protein (CRP) in Blood |
4; 4 | — |
| SECONDARY Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood |
2000.00; 2000.00; 40.60; 24.60; 410.25; 442.75 | — |
| SECONDARY Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood |
1302.41; 1126.52; 18.72; 23.95; 1252.07; 1033.85 | — |
| SECONDARY Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score |
85; 83; 11; 17; 3; 0 | — |
| SECONDARY Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score |
95; 100; 3; 0; 2; 0 | — |
| SECONDARY Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score |
82; 75; 14; 17; 5; 8 | — |
| SECONDARY Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score |
66; 75; 22; 8; 9; 17 | — |
| SECONDARY Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score |
75; 67; 20; 33; 5; 0 | — |
| SECONDARY Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score |
82.0; 82.8; 74.5; 71.4; 80.2; 86.4 | — |
Summary
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
Eligibility Criteria
Key Inclusion Criteria
Up to 5 prior regimens for Mantle cell lymphoma. Prior therapy must have included:
- Anthracycline or bendamustine-containing chemotherapy and
- Anti-CD20 monoclonal antibody therapy and
- Ibrutinib or acalabrutinib
At least 1 measurable lesion
Platelet count ≥ 75,000/uL
Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min
Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
Baseline oxygen saturation >92% on room air.
Key Exclusion Criteria
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02601313). 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.