Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma (ZUMA-11)
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|ClinicalTrials.gov Identifier: NCT03704298|
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : September 28, 2020
The primary objectives of this study are:
Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2
Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Large B-cell Lymphoma||Drug: Cyclophosphamide Drug: Fludarabine Biological: Axicabtagene Ciloleucel Biological: Utomilumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma|
|Actual Study Start Date :||November 20, 2018|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||February 2036|
Experimental: Axicabtagene ciloleucel plus utomilumab
Phase 1: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by axicabtagene ciloleucel treatment on Day 0 plus utomilumab on study Day 1 or study Day 21 and continuing once every 4 weeks (Q4W) for 6 months or until Progressive Disease, whichever comes first.
Phase 2: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by axicabtagene ciloleucel and utomilumab based on the dose/regimen selected to move forward from the Phase 1 portion of the study as recommended by the internal Safety Review Team.
Administered according to package insert
Administered according to package insert
Biological: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
Other Name: Yescarta®
Administered as an IV infusion
- For Phase 1: Percentage of Participants Experiencing Adverse Events defined as Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]Dose-limiting toxicity is defined as protocol-defined axicabtagene ciloleucel related events with onset within the first 28 days following axicabtagene ciloleucel infusion.
- For Phase 2: Complete Response Rate [ Time Frame: Up to 1 year ]Complete response rate is defined as the incidence of a complete response per the Lugano Classification (Cheson et al, 2014), as determined by study investigators.
- For Phase 1 and Phase 2: Objective Response Rate [ Time Frame: Up to 15 years ]Objective response rate is defined as the incidence of either a complete response (CR) or a partial response (PR) per Lugano Classification as determined by study investigators.
- For Phase 1 and Phase 2: Duration of Response [ Time Frame: Up to 15 years ]Among participants who experience an objective response, duration of response is defined as the date of their first objective response to disease progression per Lugano Classification as determined by study investigators or death from any cause.
- For Phase 1 and Phase 2: Progression Free Survival [ Time Frame: Up to 15 years ]Progression free survival is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano Classification as determined by study investigators or death from any cause.
- For Phase 1 and Phase 2: Overall Survival [ Time Frame: Up to 15 years ]Overall survival is defined as the time from axicabtagene ciloleucel infusion to the date of death.
- For Phase 1 and Phase 2: Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 24 months plus 30 days ]
- For Phase 1 and Phase 2: Percentage of Participants Experiencing Clinically Significant Changes in Safety Lab Values [ Time Frame: Up to 24 months plus 30 days ]
- For Phase 1 and Phase 2: Pharmacokinetics: Levels of Axicabtagene Ciloleucel in Blood [ Time Frame: Up to 2 years ]
- For Phase 1 and Phase 2: Pharmacodynamics: Levels of Cytokines in Serum [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704298
|Contact: Medical Information||1-844-454-5483(1-844-454-KITE)||firstname.lastname@example.org|
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|Study Director:||Kite Study Director||Kite, A Gilead Company|