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A Study to Investigate Safety of INT2104 Infusions in Participants Aged 18 Years of Age and Older Who Have B-cell Cancers That Came Back After Previous Treatment

Study acronym: INVISE
StatusActive, Not Recruiting
PhasePhase 1
Started2024-09-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 2026 → Oct 2026
See other at-risk trials from Gilead Sciences

Amendment history

2026-09-04
Study Status v8
Primary completion pushed: 2026-07 → 2026-10
Completion pushed: 2026-07 → 2026-10
2026-04-23
Study Status, Study Design, Contacts/Locations v7
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 34 → 10 participants
Primary completion moved earlier: 2028-03 → 2026-07
Completion moved earlier: 2031-03 → 2026-07
Study sitesdetails revised at 3 of 3 sites
2026-02-02
Study Status, Outcome Measures, References v6
Start date2024-10-07→2024-09-20
Secondary endpoints20 to 25 entries
IncidenceLevels of Vector Ribonucleic Acid (RNA) Genomes in Blood Over Time IncidenceLevels of Transgene Deoxyribonucleic Acid (DNA) Copies in Blood Over Time IncidenceLevels of CD20-targeting Chimeric Antigen Receptor (CAR20) Positive T Cells in Blood Over Time IncidenceLevels of Natural Killer (NK) Cells in Blood Over Time IncidenceNumber of Participants with CAR20-positive Cells in Accessible Tumour Tissue Over Time Change in the Levels of Lymphocyte Subsets Including B-cell Counts Over Time IncidenceObjective Response Rate (OverallORR) andas Determined by SeverityInvestigator GradeAssessme [...] [...]
Primary endpoints5 entries, revised
Number of participantsParticipants experiencingExperiencing Cytokine Release Syndrome (CRS) Number of participantsParticipants experiencingExperiencing Immune Effector Cell Neurotoxicity (ICANS) Number of participantsParticipants experiencingExperiencing dose-limiting toxicities (DLTs)
2025-12-24
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v5
Study sites2→3
Lead sponsorInterius BioTherapeutics Inc.→Kite, A Gilead Company
Eligibility criteria+7 characters
Inclusion Criteria: Age 18 or older and capable of giving signed informed consent Diagnosed with relapsed/refractory (R/R) B-NHL (Burkitt's ly [...] its, or comply with the study requirements for participation Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Secondary endpoints+1,614 characters
Incidence of Vector Ribonucleic Acid (RNA) Genomes in Blood Over Time Incidence of Transgene Deoxyribonucleic Acid (DNA) Copies in Blood Over Time Incidence of CD20-targeting Chimeric Antigen Receptor (CAR20) Positive T Cells in Blood Over Time Incidence of Natural Killer (NK) Cells in Blood Over Ti [...]
Primary endpoints6 to 5 entries
Number of Participants With AdverseAbnormal EventsClinical asLaboratory AssessedValues byand CTCAEPhysical v5.0Examination Results Number of Participants With Adverse Events as Assessed by CTCAE v5.0 Number of Participants WithTreatment-emergent Adverse Events as Assessed by CTCAE v5.0
Study title+44 characters
A Study to Investigate Safety of INT2104 Infusions in Participants Aged 18 Years of Age and Older Who Have B-cell CancerCancers That Came Back After PriorPrevious Treatment
2025-07-25
Study Identification, Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v4
Start dateestimated 2024-10→confirmed 2024-10-07
Enrollment target30→34
Study arms4→5
Eligibility criteria-35 characters
[...] informed consent Diagnosed with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (Burkitt's lymphoma are eligible for Part B only) confirmed [...] agree to use highly effective methods, including a barrier methodaftermethod after INT2104 infusion Haematological criteria: Absolute lymphocy [...] Inclusion Part B only Diagnosed with relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL), and with exceptions as detailed in exclusion criteria. Participants with Philadelphia chromosome positive (Ph+) B-ALL disease are eligible. B-ALL participants must have CD20 antigen positive leukaemi [...] e [...]
Study sitescontacts updated at 2 of 2 sites
Show 3 earlier versions
2024-10-23
Study Identification, Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 2 sites
2024-08-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 2 of 2 sites
2024-08-27
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields
2024-08-01
Original filing
The purpose of this first-in-human study is to evaluate the safety and tolerability of INT2104 when administered to humans in a broad population of participants with refractory/relapsing B-cell malignancies. Preliminary efficacy information may also be obtained. INT2104 is a gene therapy delivering a transgene for a chimeric antigen receptor (CAR) specific for CD20 (CAR20). The lentiviral vector is designed to generate CAR T and CAR Natural Killer (NK) cells inside the body following intravenous (IV) administration. Study details include the following: * The study duration will be 5 years * The treatment duration will be a one-time intravenous (IV) infusion of INT2104
Trial Details
NCT Number NCT06539338
Lead Sponsor Kite, A Gilead Company
Conditions Lymphomas Non-Hodgkin's B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 10 participants
Start Date 2024-09-20
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-08