Trial Title:
Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
NCT ID:
NCT06079164
Condition:
Relapsed/Refractory Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KITE-197
Description:
A single infusion of CAR-transduced autologous T cells administered intravenously
Arm group label:
KITE-197
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Lymphodepleting chemotherapy administered intravenously
Arm group label:
KITE-197
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Lymphodepleting chemotherapy administered intravenously
Arm group label:
KITE-197
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.
Detailed description:
Participants will be followed for approximately 24 months after the infusion of KITE-197
before transitioning to a separate Kite long-term follow-up study KT-US-982-5968, in
which they will be followed for the remainder of the 15-year follow-up period.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Relapsed or Refractory Large B-cell Lymphoma
- At least 1 measurable lesion
- Adequate organ and bone marrow function
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry-Joyce Cancer Clinic
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Facility:
Name:
St. David's South Austin Medical Center
Address:
City:
Austin
Zip:
78704
Country:
United States
Status:
Recruiting
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Facility:
Name:
Royal Prince Alfred Hospital
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Royal Brisbane and Women's Hospital
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Facility:
Name:
QEII Health Sciences Centre
Address:
City:
Halifax
Zip:
B3H 2Y9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont
Address:
City:
Montréal
Zip:
H1T 2M4
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montréal
Zip:
H3T 1E2
Country:
Canada
Status:
Not yet recruiting
Start date:
November 9, 2023
Completion date:
January 2028
Lead sponsor:
Agency:
Kite, A Gilead Company
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06079164
https://www.gileadclinicaltrials.com/study?nctid=NCT06079164
