Welcome to the Kite
Cell Therapy External Research Program Application Portal
External Research Program
The Kite External Research Program provides support for collaborative and investigator sponsored research in areas of interest to Kite that advance medical and scientific knowledge in cell therapy.
Kite accepts unsolicited clinical and non-clinical study proposals that are developed, designed, and conducted by external investigators.
The Kite External Research Program is currently limited to study proposals that address one of the areas listed below, including novel combinations, novel approaches to improve safety or efficacy, novel conditioning regimens, special populations, translational research and real world data. In more detail, the following are the areas of interest:
Studies of Axicabtagene ciluloeucel:
|Indication or Focus
||Areas of Interest|
|Follicular Lymphoma (FL)||Combination approaches (e.g., IMiD, anti-CD20, other novel agents, etc.)|
|Uses in different settings of care|
|Response assessment via MRD Testing|
|Real world evidence on sub-populations not currently studied in ZUMA-5, including QoL|
|Diffuse Large B-Cell Lymphoma (DLBCL)||Combination approaches to improve efficacy|
|Novel conditioning regimens|
|Safety approaches (beyond anakinra and siltuximab)|
|Special populations (e.g., high risk patients, PR after salvage chemo, PMBCL in 2L, etc.)|
|Real world evidence on sub-populations not currently studied in ZUMA-7 and ZUMA-1|
|Translational Research||Identification of prognostic models and predictive markers for: a) treatment strategies/patient stratification methods; and b) scoring of T cell suitability for CAR transduction and efficacy|
|Identification of biomarkers for neurotoxicity to enable primary intervention (both before and post infusion)|
|Identification of biomarkers to predict cytopenia and immune fitness|
|Concepts to increase resistance to in vivo exhaustion (FL only)|
Studies of KTE-X19:
||Areas of Interest|
|Mantle Cell Lymphoma (MCL)||Combination approaches (e.g., ibrutinib, lenalidomide, venetoclax, etc.)|
|Special populations (e.g., high-risk population, transplant-ineligible, prior allo SCT, etc.)|
|Sub-populations not currently studied in ZUMA-2 (i.e. with PR to prior therapy, 2L use)|
|Adult Acute Lymphocytic Leukemia (aALL)||Combination approaches to improve efficacy|
|Special populations (e.g. older patients, etc.)|
|Patients with insufficient response to prior therapies|
|Real world evidence on sub-populations not currently studied in ZUMA-3, QoL, and high-risk populations|
The above areas of interest may reflect uses of therapies that are investigational and have not been approved by regulatory authorities. The safety and efficacy of such uses have not been established. Kite's areas of interest are subject to change.
Out of scope:
|Axicabtagene ciluloeucel and KTE-X19||Studies already planned by or underway at Kite (CNS lymphoma, HIV, MZL)|
|Approved/authorized indications other than novel combinations|
|Studies of pipeline cell therapies, or malignancies being studied by Kite with pipeline therapies|
|Changes in cell dose|
|Translational research accompanying registration trials|
|B-cell mediated autoimmune disease with neurologic involvement|
|Axicabtagene ciluloeucel||Hematologic diseases with leukemic presentation|
|KTE-X19||Combination with asparaginase in aALL|
|Studies with KTE-X19 in lymphoma patients|
Submitting a Proposal
To learn more about our program and prepare for a proposal submission, you should contact your local Kite Medical Science Liaison (MSL).
All final applications will be submitted online through this portal by completing the submission form to provide a short synopsis of your research proposal. The application form must be completed in full before submission.
If you are a first time user, you will need to obtain a user ID. Please click the link "Need a User ID?" in the left panel.
Beyond the scientific merit of the proposal, Kite's internal review process will also consider technical, operational, and logistical capabilities of the proposed investigational site. The budget must be reasonable and appropriate for the proposed work.
The terms under which Kite, or its affiliated companies, will provide support must be contained in a written agreement. Kite provides no guarantees that it will provide support for your proposal.
In most cases investigators should expect to receive feedback within one month of submission.
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