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Looking for participantsPhase1/Phase2

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

Sponsor: Kite, A Gilead Company

NCT ID: NCT04989803

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Cyclophosphamide (drug), Fludarabine (drug), KITE-363 (biological), KITE-753 (biological)
How long the study runs
Study runs about 100 months (dates as stated)
About the drug or intervention
Cyclophosphamide — drug: Lymphodepleting chemotherapy administered intravenously · Fludarabine — drug: Lymphodepleting chemotherapy administered intravenously · KITE-363 — biological: A single infusion of CAR-transduced autologous T cells administered intravenously · KITE-753 — biological: A single infusion of CAR-transduced autologous T cells administered intravenously
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
247
Started
2021-10-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for relapsed and/or refractory b-cell lymphoma
  • • Phase1/Phase2 - 247 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with relapsed and/or refractory b-cell lymphoma

Where?

  • • London - King's College Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Eligible study 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.

Relapsed and/or Refractory B-cell Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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.

Who cannot take part

  • ✗for Phase 1a/b and Phase 2
  • ✗\- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
  • ✗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)...
See the full 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 Is This Study? (1 UK site)

King's College Hospital

London SE5 9RS, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

How to Get in Touch

Medical Information

Sponsor contact

CONTACT

844-454-5483(1-844-454-KITE) medinfo@kitepharma.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09