Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Relapsed/Refractory Large B-cell Lymphoma

Gender

N/A

Date

November 2023 - December 2027

Study Type

Interventional

Study Phase

Phase 1

Product

KITE-197, Cyclophosphamide, Fludarabine

Eligibility Information

Inclusion Criteria

Relapsed or Refractory Large B-cell Lymphoma
At least 1 measurable lesion
Adequate organ and bone marrow function

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.

Locations

Locations (8)

Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

St. David's South Austin Medical Center

Austin, Texas, United States, 78704

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont

Montréal, Canada, H1T 2M4

Jewish General Hospital

Montréal, Canada, H3T 1E2

Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma

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