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

NCT06079164 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: KT-US-656-0601
• Study Type: interventional
• Target: 39
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Relapsed/Refractory Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

  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 Outcomes (10)

• Percentage of Participants Experiencing Adverse Events (AEs)

  Enrollment up to 24 months plus 30 days

• Percentage of Participants Experiencing Serious Adverse Events (SAEs)

  Enrollment up to 24 months plus 30 days

• Overall Response Rate (ORR)

  Up to 24 months

• Duration of Response (DOR)

  Up to 24 months

• Progression-Free Survival (PFS)

  Up to 24 months

Study Arms (1)

KITE-197

EXPERIMENTAL

Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-197 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-197. Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable.

Drug: KITE-197; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

KITE-197 DRUG

A single infusion of CAR-transduced autologous T cells administered intravenously

KITE-197

Cyclophosphamide DRUG

Lymphodepleting chemotherapy administered intravenously

KITE-197

Fludarabine DRUG

Lymphodepleting chemotherapy administered intravenously

KITE-197

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Kite, A Gilead Company: lead

Study Sites (11)

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal Brisbane and Women's Hospital

South Brisbane, Queensland, 4101, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Cross Cancer Institute

Edmonton, T6G 1Z2, Canada

Location

QEII Health Sciences Centre

Halifax, B3H 2Y9, Canada

Location

Jewish General Hospital

Montreal, H3T 1E2, Canada

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Recurrence

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Kite Study Director

  Kite, A Gilead Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); AU (3); CA (3)