Relapsed and/or Refractory B-cell LymphomaPhase 1/2PALISADES-1NCT04989803
Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
A Phase 1/2 study testing Cyclophosphamide, Fludarabine and KITE-363 in people with Relapsed and/or Refractory B-cell Lymphoma, run by Kite, A Gilead Company at 36 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or Refractory B-cell Lymphoma
- What is being tested?
- Cyclophosphamide, Fludarabine and KITE-363
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 36 sitesin 6 countries
- Study dates
- 27 Oct 2021to Feb 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed and/or refractory B-cell lymphoma (R/R BCL).
- At least 1 measurable lesion.
- Adequate organ and bone marrow (BM) function.
Who cannot join
- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
- Phase 1b Cohort D only: Absolute lymphocyte count ≥ 20,000/μL.
- 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.
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- 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 concern for gastric or intestinal perforation or known contained 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.
Trial locations and contacts
36 sites in 6 countries.
36 sites in 6 countries
United States21 sites
Northside Hospital
Atlanta, Georgia, 30342
St. David's Medical Center
Austin, Texas, 78704
University of MD, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
University of Illinois Chicago
Chicago, Illinois, 60618
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, 37203
Vanderbilt University
Nashville, Tennessee, 37232
Columbia University Irving Medical Center
New York, New York, 10032
Virginia Oncology Associates
Norfolk, Virginia, 23502
Midwestern Regional Medical Center, Inc.City of Hope Chicago
Park Ridge, Illinois, 60068
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
Swedish Cancer Institute
Seattle, Washington, 98104
Norton Cancer Institute, St. Matthews Campus
Shelbyville, Kentucky, 40065
Stanford Cancer Institute
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
Australia6 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
Epworth Healthcare
East Melbourne, Victoria, 3002
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Concord Repatriation General Hospital
Sydney, New South Wales, 2139
Canada5 sites
Cross Cancer Center
Edmonton, T6G 1Z2
Queen Elizabeth II Health Sciences Centre
Halifax, B3H 2Y9
Jewish General Hospital
Montreal, H3T 1E2
McGill University Health Center
Montreal, H4A 0B1
Princess Margaret Cancer Centre - University Health Network
Toronto, M5G 2C4
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, 9700 RB
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Cyclophosphamide, Fludarabine, KITE-363, KITE-753
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Lymphodepleting chemotherapy administered intravenously
FludarabineDrug
Lymphodepleting chemotherapy administered intravenously
KITE-363Biological
A single infusion of CAR-transduced autologous T cells administered intravenously
KITE-753Biological
A single infusion of CAR-transduced autologous T cells administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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] Receives: 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). Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-753 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 months
Phase 2: ORR as per central assessment for KITE-753
Measured: Up to 36 months
Secondary outcomes (22)
Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753
Measured: Up to 24 months
Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753
Measured: Up to 24 months
Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and KITE-753
TTNT is defined as the time from KITE-363 or KITE-753 infusion to the next anticancer treatment (including stem cell transplantation [SCT]) or death from any cause, whichever occurs first.
Measured: Up to 24 months
Phase 1a/b: Complete Response (CR) Rate for KITE-363 and KITE-753
CR rate is defined as the incidence of a CR by the IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.
Measured: Up to 24 months
Phase 1a/b: Duration of Response (DOR) for KITE-363 and KITE-753
DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression per the IWG Lugano Classification or death due to any cause, whichever occurs first.
Measured: Up to 24 months
Phase 1a/b: Progression-Free Survival (PFS) for KITE-363 and KITE-753
PFS is defined as the time of KITE-363 or KITE-753 infusion to disease progression per IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) or death from any cause, whichever occurs first.
Measured: Up to 24 months
Phase 1a/b: Overall Survival (OS) for KITE-363 and KITE-753
OS is defined as the time from KITE-363 or KITE-753 infusion to death from any cause.
Measured: Up to 24 months
Phase 1a/b: Percentage of Participants who Develop Antibodies to KITE-363 and KITE-753 Chimeric Antigen Receptor (CAR) T Cells
Measured: Enrollment; up to 12 months
Phase 1a/b: Levels of KITE-363 and KITE-753 CAR T Cells
Measured: Up to 24 months
Phase 1a/b: Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15
Measured: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Inflammatory/Immune Modulating Cytokines: IFN-γ, IL-6, IL-10, IL-17, IL-1RA, Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), and Tumor Necrosis Factor-Alpha (TNF-α)
IFN-γ=Interferon-Gamma, IL-1 Receptor Antagonist=IL-1RA
Measured: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP)
Measured: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Ferritin
Measured: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Soluble IL-2 Receptor Alpha (Sil-2Rα)
Measured: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1)
Measured: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme B
Measured: Up to 3 months
Phase 2: CR rate for KITE-753
Measured: Up to 36 months
Phase 2: DOR for KITE-753
Measured: Up to 36 months
Phase 2: PFS for KITE-753
Measured: Up to 36 months
Phase 2: OS for KITE-753
Measured: Up to 36 months
Phase 2: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-753
Measured: Up to 36 months
Phase 2: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-753
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start27 Oct 2021
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989803
- Sponsor's protocol ID
- KT-US-499-0150
- Other IDs
- 2020-000562-41, 2024-511616-24
- Acronym
- PALISADES-1
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04989803
- Acronym / sponsor ID
- PALISADES-1 / KT-US-499-0150
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 a/b: KITE-363 | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-363Phase 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] |
| Phase 1 a/b: KITE-753 | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-753Phase 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] |
| Phase 2: KITE-753 | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-753Participants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (15 listed)
- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.
- Phase 1b Cohort D only: Absolute lymphocyte count ≥ 20,000/μL.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideLymphodepleting chemotherapy administered intravenously | Drug | Phase 1 a/b: KITE-363, Phase 1 a/b: KITE-753, Phase 2: KITE-753 |
| FludarabineLymphodepleting chemotherapy administered intravenously | Drug | Phase 1 a/b: KITE-363, Phase 1 a/b: KITE-753, Phase 2: KITE-753 |
| KITE-363A single infusion of CAR-transduced autologous T cells administered intravenously | Biological | Phase 1 a/b: KITE-363 |
| KITE-753A single infusion of CAR-transduced autologous T cells administered intravenously | Biological | Phase 1 a/b: KITE-753, Phase 2: KITE-753 |
Primary outcome
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
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.
Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment.
Time frame: Up to 24 months
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.
Phase 2: ORR as per central assessment for KITE-753
Time frame: Up to 36 months
22 secondary outcomes
Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753
Time frame: Up to 24 months
Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753
Time frame: Up to 24 months
Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and KITE-753
Time frame: Up to 24 months
Phase 1a/b: Complete Response (CR) Rate for KITE-363 and KITE-753
Time frame: Up to 24 months
Phase 1a/b: Duration of Response (DOR) for KITE-363 and KITE-753
Time frame: Up to 24 months
Phase 1a/b: Progression-Free Survival (PFS) for KITE-363 and KITE-753
Time frame: Up to 24 months
Phase 1a/b: Overall Survival (OS) for KITE-363 and KITE-753
Time frame: Up to 24 months
Phase 1a/b: Percentage of Participants who Develop Antibodies to KITE-363 and KITE-753 Chimeric Antigen Receptor (CAR) T Cells
Time frame: Enrollment; up to 12 months
Phase 1a/b: Levels of KITE-363 and KITE-753 CAR T Cells
Time frame: Up to 24 months
Phase 1a/b: Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15
Time frame: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Inflammatory/Immune Modulating Cytokines: IFN-γ, IL-6, IL-10, IL-17, IL-1RA, Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), and Tumor Necrosis Factor-Alpha (TNF-α)
Time frame: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP)
Time frame: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Ferritin
Time frame: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Soluble IL-2 Receptor Alpha (Sil-2Rα)
Time frame: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1)
Time frame: Up to 3 months
Phase 1a/b: Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme B
Time frame: Up to 3 months
Phase 2: CR rate for KITE-753
Time frame: Up to 36 months
Phase 2: DOR for KITE-753
Time frame: Up to 36 months
Phase 2: PFS for KITE-753
Time frame: Up to 36 months
Phase 2: OS for KITE-753
Time frame: Up to 36 months
Phase 2: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-753
Time frame: Up to 36 months
Phase 2: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-753
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kite Study Director study director
Kite, A Gilead Company
36 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclophosphamide, Fludarabine and KITE-363 in people with Relapsed and/or Refractory B-cell Lymphoma, run by Kite, A Gilead Company at 36 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Australia, Canada, Netherlands, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.