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Testing KITE-363 and KITE-753 for 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

PHASE1; PHASE2 · Gilead Sciences · NCT04989803

This study is testing two new drugs, KITE-363 and KITE-753, to see if they can help people with relapsed or hard-to-treat B-cell lymphoma feel better and stay safe during treatment.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment247 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences (industry)
Drugs / interventionschimeric antigen receptor, chemotherapy
Locations18 sites (Gilbert, Arizona and 17 other locations)
Trial IDNCT04989803 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and appropriate dosing of two investigational drugs, KITE-363 and KITE-753, in patients suffering from relapsed and/or refractory B-cell lymphoma. Participants who have previously received treatment with these drugs will be monitored in a long-term follow-up study for up to 15 years to assess ongoing safety and efficacy. The study involves administering cyclophosphamide and fludarabine as part of the treatment regimen. The goal is to gather comprehensive data on the effectiveness of these therapies in managing this challenging condition.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed and/or refractory B-cell lymphoma who have at least one measurable lesion and adequate organ function.

Not a fit: Patients with a history of certain malignancies, recent stem cell transplants, or uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with difficult-to-treat B-cell lymphoma.

How similar studies have performed: Other studies involving similar therapies have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gilbert, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsed and/or Refractory B-cell Lymphoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.