Description:
The primary objective is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in
participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL) in Cohort 3 of this
study.
Title
- Brief Title: Study to Evaluate the Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
- Official Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
KTE-C19-102 (Cohort 3)
- SECONDARY ID:
2015-005008-27
- NCT ID:
NCT04880434
Conditions
- Relapsed/Refractory Mantle Cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Fludarabine | | Brexucabtagene autoleucel (KTE-X19) |
Cyclophosphamide | | Brexucabtagene autoleucel (KTE-X19) |
Brexucabtagene autoleucel | KTE-X19, TECARTUS™ | Brexucabtagene autoleucel (KTE-X19) |
Purpose
The primary objective is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in
participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL) in Cohort 3 of this
study.
Detailed Description
Study KTE-C19-102 (NCT02601313) enrolled participants with r/r MCL who have been treated with
up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and
Cohort 2. However, to fulfill FDA Postmarketing Requirement Cohort 3 is added to the study.
It will include participants with r/r MCL who have been treated with up to 5 prior regimens
but have not received prior therapy with a BTKi.
The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be
analyzed separately. Therefore, this separate registration is only for Cohort 3.
Trial Arms
Name | Type | Description | Interventions |
---|
Brexucabtagene autoleucel (KTE-X19) | Experimental | Participants with relapsed/refractory mantle cell lymphoma will receive conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day intravenous (IV) infusion for 3 days followed by a single infusion of brexucabtagene autoleucel (KTE-X19) at a targeted dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg, with a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 3. | - Fludarabine
- Cyclophosphamide
- Brexucabtagene autoleucel
|
Eligibility Criteria
Key Inclusion Criteria:
- Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or
bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy.
Individuals must not have received prior therapy with a BTKi.
- At least 1 measurable lesion
- Platelet count ≥ 75,000/uL
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/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). Individuals with a history
of hepatitis infection must have cleared their infection as determined by 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) Per Lugano Classification as Determined by the Independent Radiology Review Committee (IRRC) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | ORR is defined as the incidence of either a complete response (CR) or partial response (PR) per the Lugano Classification as determined by IRRC. |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | DOR is defined as the time from their first objective response to disease progression or death. |
Measure: | Percentage of Participants With Best Objective Response (BOR) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | Best objective response is defined as the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable as best response to treatment. |
Measure: | Objective Response Rate (ORR) per Lugano Classification as Determined by Investigators |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | ORR, as determined by investigators, is defined as the incidence of either a complete response (CR) or partial response (PR) per the Lugano Classification. |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants With Clinically Significant Changes in Laboratory Values |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Who Develop Anti-CD19 CAR Antibodies |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Levels of Anti-CD19 CAR T Cells in Blood |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Levels of Cytokines in Serum |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Scale Score |
Time Frame: | Baseline and up to 24 months |
Safety Issue: | |
Description: | The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. |
Measure: | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Visual Analogue Scale (VAS) Score |
Time Frame: | Baseline and up to 24 months |
Safety Issue: | |
Description: | EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. |
Measure: | Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score from Baseline Over Time |
Time Frame: | Baseline and up to 6 months |
Safety Issue: | |
Description: | EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores are averaged, transformed to 0-100 scale; higher score indicate high QoL. A positive change from baseline indicates better quality of life. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Kite, A Gilead Company |
Last Updated
August 10, 2021