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

Study acronym: PALISADES-1
StatusRecruiting
PhasePhase 1/2
Started2021-10-27
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
Study Status, Contacts/Locations v49
Trial sites expanded: 28 → 34 locations
2026-06-26
Study Status, Contacts/Locations v48
Trial sites expanded: 21 → 26 locations
2026-06-02
Study Status, Contacts/Locations v47
Trial sites expanded: 18 → 21 locations
2026-04-21
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v46
Trial sites expanded: 14 → 18 locations
Primary completion pushed: 2027-10 → 2030-02
Completion pushed: 2027-10 → 2030-02
Eligibility criteria+2 characters
[...] therapy in the case of breast cancer) for at least 3 years. History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma. History of allogeneic stem cell transplant (allo-SCT). Auto- [...] nodeficiency 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. [...] [...]
Secondary endpoints24 to 22 entries
Phase 2: ctDNA MRD-Negative CR Rate of KITE-753 Phase 2: Overall ctDNA MRD Negativity of KITE-753
2026-01-06
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v45
PhasePhase 1→Phase 1/2
Enrollment target114→247
Study arms2→3
Eligibility criteria+153 characters
Key Inclusion Criteria: for Phase 1a/b and Phase 2 Relapsed and/or refractory B-cell lymphoma (R/R BCL). At le [...] 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 [...]
Secondary endpoints16 to 24 entries
Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 orand KITE-753 Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 orand KITE-753 Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 orand KITE-753 Phase 1a/b: Complete Response (CR) Rate for KITE-363 orand KITE-753 Phase 1a/b: Duration of Response (DOR) for KITE-363 orand KITE-753 Phase 1a/b: Progression-Free Survival (PFS) for KITE-363 orand KITE-753 Phase 1a/b: Overall Survival (OS) for KITE-363 orand KITE-753 Phase 1a/b: Percentage of [...] [...]
Primary endpoints2 to 3 entries
Phase 1b: Objective Response Rate (ORR) for KITE-363 orand KITE-753 as per investigator's assessment. Phase 2: ORR as per central assessment for KITE-753
Show 44 earlier versions
2025-11-17
Study Status v44
Re-verified, no change to tracked fields
2025-10-13
Study Status v43
Primary completion date2027-05→2027-10
Completion date2027-05→2027-10
2025-05-23
Study Status, Contacts/Locations v42
Study sitesdetails revised at 1 of 14 sites
2025-04-18
Study Status v41
Primary completion date2026-07→2027-05
Completion date2026-07→2027-05
2024-12-23
Study Status, Contacts/Locations v40
Study sites12→14
2024-11-07
Study Status v39
Re-verified, no change to tracked fields
2024-10-28
Study Status, Contacts/Locations v38
Study sites10→12
2024-09-05
4 amendments v34-v37
4 re-verifications since 2024-06-20, no change to tracked fields
2024-05-24
Study Status, Contacts/Locations v33
Study sites9→10
2024-04-02
Study Status, Contacts/Locations v32
Study sitesdetails revised at 1 of 9 sites
2024-03-08
Study Status v31
Primary completion date2025-07→2026-07
Completion date2027-01→2026-07
2024-01-29
Study Status v30
Primary completion date2024-04→2025-07
Completion date2041-01→2027-01
2023-12-20
Study Status, Contacts/Locations v29
Study sites8→9
2023-12-05
3 amendments v26-v28
3 re-verifications since 2023-10-18, no change to tracked fields
2023-09-08
Study Status, Contacts/Locations v25
Study sites6→8
2023-08-04
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v24
Enrollment target80→114
Study sites5→6
Study arms1→2
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), KITE-363 (Biological)→Cyclophosphamide (Drug), Fludarabine (Drug), KITE-363 (Biological), KITE-753 (Biological)
Eligibility criteria+36 characters
[...] o-SCT). Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion. Presence of fungal, bacterial, viral, or other inf [...] f 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] pos [...]
Secondary endpoints16 entries, revised
Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 or KITE-753 Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 or KITE-753 Time To Next Treatment (TTNT) for KITE-363 or KITE-753 Complete Response (CR) Rate for KITE-363 or KITE-753 Duration of Response (DOR) for KITE-363 or KITE-753 Progression-Free Survival (PFS) for KITE-363 or KITE-753 Overall Survival (OS) for KITE-363 or KITE-753 Percentage of Participants who Develop Antibodies to KITE-363 CAR Levels ofor KITE-363753 Chimeric Antigen Receptor (CAR) T Cells [...] [...]
Primary endpoints2 entries, revised
Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limitinglimiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753 Phase 1b: Objective Response Rate (ORR) for KITE-363 or KITE-753
Study description-17 characters
Five years after the lastEligible study participant is randomized, participants who have received anIP infusionadministration ofwith either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (studyStudy KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
Study title+12 characters
Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
2023-04-21
Study Status, Contacts/Locations v23
Study sites4→5
2023-03-30
Study Identification, Study Status, Study Description v22
Study title-35 characters
Study Evaluating the Safety and Efficacy of KITE-363 in Participants With Relapsed and/or Refractory B-cell Lymphoma
2023-02-06
Study Status, Contacts/Locations v21
Study sites3→4
2022-12-20
Study Status, Study Description, Eligibility v20
Eligibility criteria+77 characters
[...] r carcinoma in situ (eg, cervix, bladder, or breast) unless the individual has been 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 Richter's transformation o [...]
Study description+256 characters
Five years after the last study participant is randomized, participants who have received an infusion of KITE-363 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.
2022-11-22
4 amendments v16-v19
4 re-verifications since 2022-08-16, no change to tracked fields
2022-07-15
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 3 sites
2022-06-16
4 amendments v11-v14
4 re-verifications since 2022-04-11, no change to tracked fields
2022-03-17
Study Status, Contacts/Locations v10
Primary completion date2024-02→2024-04
Study sites2→3
2022-02-17
Study Status v9
Primary completion date2026-01→2024-02
2022-01-05
Study Status v8
Re-verified, no change to tracked fields
2021-12-09
Study Status, Contacts/Locations v7
Study sites1→2
2021-12-02
Study Status v6
Re-verified, no change to tracked fields
2021-11-18
Study Status, Eligibility v5
Start dateestimated 2021-11→confirmed 2021-10-27
Eligibility criteria-200 characters
[...] rgan and bone marrow (BM) function. Key Exclusion Criteria: Grade 4 cytokine release syndrome (CRS) or Grade 4 neurologic toxicity attributed to prior treatment with a CAR T-cell therapy or other genetically modified T-cell therapy targeting CD19 and/or CD20. History of malignancy other than nonmelanoma skin cancer or [...]
2021-10-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v4
Trial statusNot Yet Recruiting→Recruiting
Start date2021-10→2021-11
Study sites1 entry, revised
The University of Texas, MD Anderson Cancer Center
2021-09-17
Study Status v3
Re-verified, no change to tracked fields
2021-08-26
Study Status, Contacts/Locations v2
Study sites0→1
2021-08-20
Study Status, Eligibility v1
Start date2021-08→2021-10
Eligibility criteria-156 characters
[...] rable lesion. Adequate organ and bone marrow (BM) function. Prior treatment with CAR T-cell therapy or other genetically modified T-cell therapy targeting cluster of differentiation 19 (CD19) and/or CD20 is allowed. Key Exclusion Criteria: Grade 4 cytokine release syndrome (C [...]
2021-07-26
Original filing
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.
Trial Details
NCT Number NCT04989803
Lead Sponsor Kite, A Gilead Company
Conditions Relapsed and/or Refractory B-cell Lymphoma
Enrollment 247 participants
Start Date 2021-10-27
Primary Completion 2030-02 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-25