Recruiting
Phase 1
Phase 2

KITE-363 & KITE-753

Sponsor:

Kite, A Gilead Company

Code:

NCT04989803

Conditions

Relapsed and/or Refractory B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Fludarabine

KITE-363

KITE-753

Study Details

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

Study ID

NCT04989803

Start date

Oct 27, 2021

Status verified date

Aug, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria: for Phase 1a/b and Phase 2

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

Key Exclusion Criteria: for Phase 1a/b and Phase 2

\- 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

247 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 a/b: KITE-363

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.

\[Recruitment completed for this arm\]

experimental: Phase 1 a/b: KITE-753

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.

\[Recruitment open for frontline LBCL and r/r MCL for this arm\]

experimental: Phase 2: KITE-753

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).

Interventions

Cyclophosphamide

Lymphodepleting chemotherapy administered intravenously

Fludarabine

Lymphodepleting chemotherapy administered intravenously

KITE-363

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

KITE-753

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

Primary outcome measure

  • Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753 [ Time Frame: Up to 28 days ]
  • Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment. [ Time Frame: Up to 15 years ]
  • Phase 2: ORR as per central assessment for KITE-753 [ Time Frame: Up to 15 years ]

Central Contacts and Locations

Central contacts

Medical Information

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

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

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

Recruiting

Duarte, California, United States, 91010

Stanford Cancer Institute

Recruiting

Stanford, California, United States, 94305

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Midwestern Regional Medical Center, Inc.City of Hope Chicago

Recruiting

Park Ridge, Illinois, United States, 60068

Norton Cancer Institute, St. Matthews Campus

Recruiting

Shelbyville, Kentucky, United States, 40065

University of MD, Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

The Ohio State University Wexner Medical Center - James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

Tennessee Oncology, PLLC - Investigational Drug Services

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

St. David's Medical Center

Recruiting

Austin, Texas, United States, 78704

The University of Texas, MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Jewish General Hospital

Recruiting

Montreal, Canada, H3T 1E2

McGill University Health Center

Recruiting

Montreal, Canada, H4A 0B1

More Information

Sponsor

Kite, A Gilead Company

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kite, A Gilead Company on 2026-08-28.