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

NCT04989803 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: KT-US-499-01502020-000562-412024-511616-24
• Study Type: interventional
• Target: 247
• Locations: 5 countries
• Sites: 18

Brief 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.

Conditions

Relapsed and/or Refractory B-cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753

  DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.

  Up to 28 days

• Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment.

  ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.

  Up to 15 years

• Phase 2: ORR as per central assessment for KITE-753

  Up to 15 years

Secondary Outcomes (22)

• Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753

  Up to 15 years

• Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753

  Up to 15 years

• Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and KITE-753

  Up to 15 years

• Phase 1a/b: Complete Response (CR) Rate for KITE-363 and KITE-753

  Up to 15 years

• Phase 1a/b: Duration of Response (DOR) for KITE-363 and KITE-753

  Up to 15 years

Study Arms (3)

Phase 1 a/b: KITE-363

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-363 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-363. 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-363 at 1 or more dose-level deemed to be tolerable. \[Recruitment completed for this arm\]

Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-363

Phase 1 a/b: KITE-753

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-753 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-753. 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-753 at 1 or more dose-level deemed to be tolerable. \[Recruitment open for frontline LBCL and r/r MCL for this arm\]

Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-753

Phase 2: KITE-753

EXPERIMENTAL

Participants with r/r large B-cell lymphoma who have received at least 2 prior lines of systemic therapy will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells /kg intravenously (IV).

Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-753

Interventions

Cyclophosphamide DRUG

Lymphodepleting chemotherapy administered intravenously

Phase 1 a/b: KITE-363; Phase 1 a/b: KITE-753; Phase 2: KITE-753

Fludarabine DRUG

Lymphodepleting chemotherapy administered intravenously

Phase 1 a/b: KITE-363; Phase 1 a/b: KITE-753; Phase 2: KITE-753

KITE-363 BIOLOGICAL

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

Phase 1 a/b: KITE-363

KITE-753 BIOLOGICAL

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

Phase 1 a/b: KITE-753; Phase 2: KITE-753

Eligibility Criteria

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

You may qualify if:

• Relapsed and/or refractory B-cell lymphoma (R/R BCL).
• At least 1 measurable lesion.
• Adequate organ and bone marrow (BM) function.

You may not qualify if:

• \- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
• History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
• History of allogeneic stem cell transplant (allo-SCT).
• Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) (hepatitis B surface \[HBs\] antigen \[HBsAg\] positive) infection, or hepatitis C (anti-hepatitis C virus \[HCV\] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.
• Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma.
• History or presence of a CNS disorder.
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
• Primary immunodeficiency.
• History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 90 days.
• Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and/or transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.
• Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.

Sponsors & Collaborators

• Kite, A Gilead Company: lead

Study Sites (18)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States

RECRUITING

Stanford Cancer Institute

Stanford, California, 94305, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Midwestern Regional Medical Center, Inc.City of Hope Chicago

Park Ridge, Illinois, 60068, United States

RECRUITING

University of MD, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, 43210, United States

RECRUITING

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

Concord Repatriation General Hospital

Sydney, New South Wales, 2139, Australia

RECRUITING

Epworth Healthcare

East Melbourne, Victoria, 3002, Australia

RECRUITING

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

RECRUITING

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

RECRUITING

King's College Hospital

London, SE5 9RS, United Kingdom

COMPLETED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

Cyclophosphamide; fludarabine

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

Central Study Contacts

Medical Information

CONTACT

844-454-5483(1-844-454-KITE); medinfo@kitepharma.com

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: July 26, 2021
• First Posted: August 4, 2021
• Study Start: October 27, 2021
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); US (12); DE (1); AU (3); GB (1)