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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06079164




Registration number
NCT06079164
Ethics application status
Date submitted
6/10/2023
Date registered
12/10/2023
Date last updated
7/06/2024

Titles & IDs
Public title
Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
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
Secondary ID [1] 0 0
KT-US-656-0601
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Timepoint [1] 0 0
First infusion date of KITE-197 up to 28 days
Primary outcome [2] 0 0
Phase 1b: Complete Remission (CR) Rate
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Percentage of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Enrollment up to 24 months plus 30 days
Secondary outcome [2] 0 0
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Enrollment up to 24 months plus 30 days
Secondary outcome [3] 0 0
Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Progression-Free Survival (PFS)
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Event Free Survival (EFS)
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Time to Next Treatment (TTNT)
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion
Timepoint [9] 0 0
Up to 24 months
Secondary outcome [10] 0 0
Proportion of Immune Cell Subsets in KITE-197
Timepoint [10] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
Key

- Relapsed or Refractory Large B-cell Lymphoma

- At least 1 measurable lesion

- Adequate organ and bone marrow function

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Canada
State/province [6] 0 0
Montréal

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kite, A Gilead Company
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06079164
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kite Study Director
Address 0 0
Kite, A Gilead Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries