A Phase 1/2 interventional study of Cyclophosphamide and Fludarabine in Relapsed and/or Refractory B-cell Lymphoma, sponsored by Kite, A Gilead Company. Active, not recruiting at 36 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Kite, A Gilead Company (part of Gilead Sciences) · Phase 1/2, Interventional, and Treatment
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Among 398 studies in Lymphoma, B-Cell with a site in United States — 91 open to participants now, 158 under way, 12 of them phase 3. Lymphoma, B-Cell · United States.
Among the 398 studies in Lymphoma, B-Cell with a site in United States, this one is the 35th largest by planned enrollment of the 380 interventional ones that give a count, is one of 31 that started in 2021, is one of 75 in phase 1/2, reaches primary completion later than 134 of the 157 other live ones, and was the 271st registered.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
Browse Lymphoma, B-Cell studies →91 of the 398 studies in Lymphoma, B-Cell with a site in United States are open now. Recruiting first, the newest first:
Umoja Biopharma · Sites in United States
Ages 18+
Nurix Therapeutics, Inc. · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in United States
Ages 18+
Paolo Caimi, MD · Sites in United States
Ages 18+
University of Michigan Rogel Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Lymphoma, B-Cell studies recruiting now, 129 (62%) set no upper age limit and 60 (29%) stop at 75 or younger; 37 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
398 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 236 · Phase 2 188 · Phase 3 23 · Phase 4 1
First in 1991; this study’s year is marked. 31 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 247 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Median enrollment 37 across the 380 interventional studies, 150 across the 17 observational. Of the 217 that completed or were terminated, 111 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
176 of 398 have an industry lead sponsor. The 10 most frequent:
This study is registered under Kite, A Gilead Company, one of the names counted as Gilead Sciences. Under that name alone:
Kite, A Gilead Company is the lead sponsor of 40 studies on the registry; 8 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Gilead Sciences has 9 studies filed under Lymphoma, B-Cell — fewer than ten, so there is no comparison to draw.
52 of the studies in Lymphoma, B-Cell with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04529772Phase 3Acerta Pharma BVA Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) | 2027-02-22 |
| NCT04759586Phase 3National Cancer Institute (NCI)Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma | 2027-06-30 |
| NCT05254743Phase 3Loxo Oncology, Inc.A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | 2027-10 |
| NCT06047080Phase 3Hoffmann-La RocheAn Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma | 2027-10-01 |
| NCT04662255Phase 3Loxo Oncology, Inc.Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) | 2027-11 |
Add all 52 to your calendar (.ics) → With an account.
Among the 398 studies in Lymphoma, B-Cell with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
The criteria were revised on the registry on Oct 28, 2026. See what changed
Key Inclusion Criteria: for Phase 1a/b and Phase 2
Key Exclusion Criteria: for Phase 1a/b and Phase 2
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. \[Recruitment completed for this arm\]
Drug: Cyclophosphamide · Drug: Fludarabine · Biological: 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-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. \[Recruitment open for frontline LBCL and r/r MCL for this arm\]
Drug: Cyclophosphamide · Drug: Fludarabine · Biological: 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).
Drug: Cyclophosphamide · Drug: Fludarabine · Biological: KITE-753
Lymphodepleting chemotherapy administered intravenously
Lymphodepleting chemotherapy administered intravenously
A single infusion of CAR-transduced autologous T cells administered intravenously
A single infusion of CAR-transduced autologous T cells administered intravenously
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.
Time frame: 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.
Time frame: Up to 24 months
Phase 2: ORR as per central assessment for KITE-753
Time frame: Up to 36 months
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
IFN-γ=Interferon-Gamma, IL-1 Receptor Antagonist=IL-1RA
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
Plan to share: No
Started Oct 2021 (actual). Primary completion is estimated for Feb 2030, 100 months after the start.
Of 94 phase 1/2 interventional studies under Lymphoma, B-Cell, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 55 and three quarters within 96. This study's planned 100 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Autologous Anti-CD19/CD20 CAR-T Cells KITE-363 · Autologous Anti-CD19/Anti-CD20 CAR-T Cells KITE-753