Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
KITE-197: A single infusion of CAR-transduced autologous T cells administered intravenously
Cyclophosphamide: Lymphodepleting chemotherapy administered intravenously
Fludarabine: Lymphodepleting chemotherapy administered intravenously
Study 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.
Eligibility
Primary outcome measure(s)
- Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) — First infusion date of KITE-197 up to 28 days
- Phase 1b: Complete Remission (CR) Rate — Up to 24 months
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.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Sylvester Comprehensive Cancer Center | Miami | Florida | |
| University of Chicago Medical Center | Chicago | Illinois | |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | |
| St. David's South Austin Medical Center | Austin | Texas | |
| Swedish Cancer Institute | Seattle | Washington | |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | |
| Royal Brisbane and Women's Hospital | South Brisbane | Queensland | |
| The Alfred Hospital | Melbourne | Victoria | |
| Cross Cancer Institute | Edmonton | Canada | |
| QEII Health Sciences Centre | Halifax | Canada | |
| Jewish General Hospital | Montreal | Canada |
More Kite, A Gilead Company trials in Australia
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06079164 on ClinicalTrials.gov ↗ ← All trials in Australia