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

Relapsed/Refractory Large B-cell Lymphoma Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06079164
• Other study ID #: KT-US-656-0601
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 9, 2023
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Relapsed/Refractory Large B-cell Lymphoma

Intervention

Drug:
• KITE-197
A single infusion of CAR-transduced autologous T cells administered intravenously
• Cyclophosphamide
Lymphodepleting chemotherapy administered intravenously
• Fludarabine
Lymphodepleting chemotherapy administered intravenously

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Canada	Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont	Montréal
Canada	Jewish General Hospital	Montréal
United States	St. David's South Austin Medical Center	Austin	Texas
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Henry-Joyce Cancer Clinic	Nashville	Tennessee
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kite, A Gilead Company

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)		First infusion date of KITE-197 up to 28 days
Primary	Phase 1b: Complete Remission (CR) Rate	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.	Up to 24 months
Secondary	Percentage of Participants Experiencing Adverse Events (AEs)		Enrollment up to 24 months plus 30 days
Secondary	Percentage of Participants Experiencing Serious Adverse Events (SAEs)		Enrollment up to 24 months plus 30 days
Secondary	Overall Response Rate (ORR)	ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma therapy, per the Lugano Classification, as determined by the investigator.	Up to 24 months
Secondary	Duration of Response (DOR)	DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.	Up to 24 months
Secondary	Progression-Free Survival (PFS)	PFS is defined as the time from KITE-197 infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.	Up to 24 months
Secondary	Event Free Survival (EFS)	EFS is defined as the time from KITE-197 infusion to the earliest occurrence of death due to any cause, disease progression/relapse per investigator, or initiation of new anti-lymphoma therapy.	Up to 24 months
Secondary	Time to Next Treatment (TTNT)	TTNT is defined as time from KITE-197 infusion to the start of subsequent new lymphoma therapy or death from any cause.	Up to 24 months
Secondary	Overall Survival (OS)	OS is defined as the time from KITE-197 infusion to death from any cause.	Up to 24 months
Secondary	Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion		Up to 24 months
Secondary	Proportion of Immune Cell Subsets in KITE-197		Up to 24 months

External Links

•   Gilead Clinical Trials Website