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RecruitingLast updated: 11 May 2026

PALISADES-1: Learning how safe and effective two new drugs, called KITE-363 and KITE-753, are in people with relapsed and/or refractory B-cell lymphomaA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

PALISADES-1

Clinical summary

Summary

These drugs being tested in this trial are CAR-T cell therapies. This is a type of treatment that uses a person's own immune cells, which are collected, modified in a laboratory to better recognise cancer cells, and then returned to the body to help fight the cancer.

Eligible participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate, long-term follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Conditions

This trial is treating people with relapsed and/or refractory B-cell lymphoma

Eligibility

Inclusion

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.

Exclusion

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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT04989803 *
  • 2024-511616-24 *
  • KT-US-499-0150; 2020-000562-41

Trial sponsor

Kite, A Gilead Company

Scientific Title

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

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