NCT04989803

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 247 (estimated)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

Detailed description

Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Conditions

• Relapsed and/or Refractory B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy administered intravenously
DRUG	Fludarabine	Lymphodepleting chemotherapy administered intravenously
BIOLOGICAL	KITE-363	A single infusion of CAR-transduced autologous T cells administered intravenously
BIOLOGICAL	KITE-753	A single infusion of CAR-transduced autologous T cells administered intravenously

Timeline

• Start date: 2021-10-27
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2021-08-04
• Last updated: 2026-01-07

Locations

14 sites across 5 countries: United States, Australia, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study