Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma (ZUMA-19)
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|ClinicalTrials.gov Identifier: NCT04314843|
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : February 16, 2021
The primary objectives of this study are:
Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for Phase 2.
Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or refractory large B-cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Large B-cell Lymphoma||Drug: Cyclophosphamide Drug: Fludarabine Biological: Lenzilumab Biological: Axicabtagene Ciloleucel||Phase 1 Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects With Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)|
|Actual Study Start Date :||May 26, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2037|
Experimental: Lenzilumab and Axicabtagene Ciloleucel
Phase 1: Participants will receive cyclophosphamide and fludarabine lymphodepleting chemotherapy followed by sequenced therapy of lenzilumab and axicabtagene ciloleucel on Day 0 to determine a recommended Phase 2 dose (RP2D) of lenzilumab.
Phase 2: Participants will receive cyclophosphamide and fludarabine lymphodepleting chemotherapy followed by sequenced therapy of lenzilumab, at the RP2D, and axicabtagene ciloleucel on Day 0.
Administered according to package insert
Administered according to package insert
Administered as an intravenous (IV) infusion
Other Name: Humaneered® anti-human GM-CSF monoclonal antibody
Biological: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously.
Other Name: Yescarta®
- For Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy with Lenzilumab and Axicabtagene [ Time Frame: Up to 28 days ]Dose-limiting toxicity is defined as protocol-defined sequenced therapy-related events with onset within the first 28 days following lenzilumab and axicabtagene ciloleucel infusion.
- For Phase 2: Percentage of Participants Experiencing Grade 2 or Higher Neurologic Events Within 28 days of Axicabtagene Ciloleucel Administration [ Time Frame: Up to 28 days ]
- For Phase 1 and Phase 2: Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 12 months ]
- For Phase 1 and Phase 2: Percentage of Participants Experiencing Serious Adverse Events [ Time Frame: Up to 24 months ]
- For Phase 1 and Phase 2: Percentage of Participants Experiencing Cytokine Release Syndrome [ Time Frame: Up to 24 months ]
- For Phase 1 and Phase 2: Percentage of Participants Experiencing Neurologic Events [ Time Frame: Up to 24 months ]
- For Phase 1 and Phase 2: Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]ORR is defined as the incidence of either a Complete Response (CR) or a Partial Response (PR) per the International Working Group (IWG) Lugano Classification as determined by the study investigators.
- For Phase 1 and Phase 2: Complete Response (CR) Rate [ Time Frame: Up to 2 years ]CR rate is defined as the incidence of CR per the IWG Lugano Classification as determined by the study investigators
- For Phase 1 and Phase 2: Duration of Response (DOR) in Participants who Experience an Objective Response [ Time Frame: Up to 15 years ]Among participants who experience an objective response, DOR is defined as the date of participants' first objective response to disease progression per the IWG Lugano Classification as determined by study investigators or death from any cause.
- For Phase 1 and Phase 2: Progression-Free Survival (PFS) [ Time Frame: Up to 15 years ]PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the IWG Lugano Classification as determined by study investigators or death from any cause.
- For Phase 1 and Phase 2: Overall Survival (OS) [ Time Frame: Up to 15 years ]OS is defined as the time from axicabtagene ciloleucel infusion to the date of death.
- For Phase 1 and Phase 2: Pharmacodynamics: Levels of Cytokines in Blood [ Time Frame: Up to 3 months ]
- For Phase 1 and Phase 2: Axicabtagene Ciloleucel Pharmacokinetics: Levels of anti-CD19 CAR T Cells in Blood [ Time Frame: Up to 12 months ]
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): NCT04314843
|Contact: Medical Information||844-454-5483(1-844-454-KITE)||email@example.com|
|United States, California|
|Palo Alto, California, United States, 94305|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Evanston, Illinois, United States, 60208|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Columbia University Medical Center, New York-Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Levine Cancer Center||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Kite Study Director||Kite, A Gilead Company|