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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06079164
Registration number
NCT06079164
Ethics application status
Date submitted
6/10/2023
Date registered
12/10/2023
Titles & IDs
Public title
Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
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Scientific title
A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma
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Secondary ID [1]
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KT-US-656-0601
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Large B-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - KITE-197
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Experimental: KITE-197 - Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-197 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-197.
Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable.
Treatment: Drugs: KITE-197
A single infusion of CAR-transduced autologous T cells administered intravenously
Treatment: Drugs: Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
Treatment: Drugs: Fludarabine
Lymphodepleting chemotherapy administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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First infusion date of KITE-197 up to 28 days
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Primary outcome [2]
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Phase 1b: Complete Remission (CR) Rate
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Assessment method [2]
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Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
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Timepoint [2]
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Up to 24 months
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Secondary outcome [1]
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Percentage of Participants Experiencing Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Enrollment up to 24 months plus 30 days
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Secondary outcome [2]
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Percentage of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [2]
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Timepoint [2]
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Enrollment up to 24 months plus 30 days
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Secondary outcome [3]
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Overall Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma therapy, per the Lugano Classification, as determined by the investigator.
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Timepoint [3]
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Up to 24 months
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.
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Timepoint [4]
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Up to 24 months
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Secondary outcome [5]
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Progression-Free Survival (PFS)
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Assessment method [5]
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PFS is defined as the time from KITE-197 infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.
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Timepoint [5]
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Up to 24 months
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Secondary outcome [6]
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Event Free Survival (EFS)
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Assessment method [6]
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EFS is defined as the time from KITE-197 infusion to the earliest occurrence of death due to any cause, disease progression/relapse per investigator, or initiation of new anti-lymphoma therapy.
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Timepoint [6]
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Up to 24 months
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Secondary outcome [7]
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Time to Next Treatment (TTNT)
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Assessment method [7]
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TTNT is defined as time from KITE-197 infusion to the start of subsequent new lymphoma therapy or death from any cause.
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Timepoint [7]
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Up to 24 months
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Secondary outcome [8]
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Overall Survival (OS)
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Assessment method [8]
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OS is defined as the time from KITE-197 infusion to death from any cause.
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Timepoint [8]
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Up to 24 months
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Secondary outcome [9]
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Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion
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Assessment method [9]
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Timepoint [9]
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Up to 24 months
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Secondary outcome [10]
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Proportion of Immune Cell Subsets in KITE-197
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Assessment method [10]
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Timepoint [10]
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Up to 24 months
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Eligibility
Key inclusion criteria
Key
* Relapsed or Refractory Large B-cell Lymphoma
* At least 1 measurable lesion
* Adequate organ and bone marrow function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 2 years
* History of Richter's transformation of chronic leukemic lymphoma
* History of allogenic stem cell transplant (SCT)
* Autologous SCT within 6 weeks of planned KITE-197 infusion
* Prior CD19 targeted antibody, such as tafasitamab and loncastuximab with the exception of individuals who have previously achieved an objective response to such therapy and their tumor expresses CD19 by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (IHC) at the time of screening. Individuals who meet these criteria may be eligible
* Prior treatment with bendamustine within 6 months of enrollment
* Prior CAR therapy or other genetically modified cell therapy
* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management
* History of HIV infection or acute or chronic active hepatitis B or C infection
* History or presence of a clinically significant central nervous system (CNS) disorder Note: Prior or active CNS involvement by lymphoma is not an exclusion criterion.
* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months before enrollment
* Presence of primary immunodeficiency
* History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
* History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3 months before enrollment. Catheter induced DVT which has been treated for at least 6 weeks prior to enrollment is permitted
* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
39
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - South Brisbane
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Tennessee
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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United States of America
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State/province [5]
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Washington
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Country [6]
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Canada
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State/province [6]
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Halifax
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Country [7]
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Canada
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State/province [7]
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Montréal
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Kite, A Gilead Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL. The primary objectives of this study are: Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b. Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.
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Trial website
https://clinicaltrials.gov/study/NCT06079164
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kite Study Director
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Address
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Kite, A Gilead Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Medical Information
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Address
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Country
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Phone
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844-454-5483(1-844-454-KITE)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06079164