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INT2104

Phase 1

Lymphomas Non-Hodgkin's B-Cell | Gene therapy | Oncology |Gilead Sciences, Inc.|Last Updated: Apr 24, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

INT2104 · 1 trial · 2 indications

Phase 1 1
NCT06539338A 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 TreatmentLymphomas Non-Hodgkin's B-Cell
ACTIVE NOT_RECRUITING10 Analytics
PHASE1ACTIVE NOT_RECRUITING
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
Lymphomas Non-Hodgkin's B-CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment-emergent Adverse Events
Up to 5 years

Number of Participants With Adverse Events as Assessed by CTCAE v5.0

Number of Participants With Abnormal Clinical Laboratory Values and Physical Examination Results
Baseline, up to Day 29

Number of Participants With abnormal clinical laboratory values as Assessed by CTCAE v5.0

Number of Participants Experiencing Cytokine Release Syndrome (CRS)
Baseline, up to Day 29

Number of participants experiencing Cytokine Release Syndrome (CRS)

Number of Participants Experiencing Immune Effector Cell Neurotoxicity (ICANS)
28 Days

Number of participants experiencing Immune Effector Cell Neurotoxicity (ICANS)

Number of Participants Experiencing dose-limiting toxicities (DLTs)
28 Days

Number of participants experiencing dose-limiting toxicities (DLTs)

Secondary Endpoints

Levels of Vector Ribonucleic Acid (RNA) Genomes in Blood Over Time
Baseline, up to Day 29
Levels of Transgene Deoxyribonucleic Acid (DNA) Copies in Blood Over Time
Baseline, up to Day 29
Levels of CD20-targeting Chimeric Antigen Receptor (CAR20) Positive T Cells in Blood Over Time
Baseline, up to Day 29
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INT2104 Dose Level 1EXPERIMENTALSingle IV administration of INT2104
INT2104 Dose Level 2EXPERIMENTALSingle IV administration of INT2104
INT2104 Dose Level 3EXPERIMENTALSingle IV administration of INT2104
INT2104 Dose Level 4EXPERIMENTALSingle IV administration of INT2104
INT2104 Recommended DoseEXPERIMENTALSingle IV administration of INT2104

Interventions

NameTypeDescription
INT2104GENETICINT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Diagnosed with relapsed/refractory (R/R) B-NHL (Burkitt's lymphoma are eligible for Part B only) confirmed by histology or flow cytometry Note: Bone Marrow involvement is allowed * B-NHL must have CD20 antigen positive tumour confirmed from a tumour biopsy taken at screening *...

Countries:AustraliaSpain
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Frequently asked questions about INT2104

What is INT2104 used for?

INT2104 is an investigational gene therapy being studied for the treatment of B-cell cancers, specifically non-Hodgkin's B-cell lymphomas and precursor cell lymphoblastic leukemia-lymphoma. It is intended for patients aged 18 years and older whose cancer has returned after previous treatment.

Who makes INT2104?

INT2104 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is currently sponsoring a Phase 1 clinical trial to investigate the safety of the therapy.

What phase is INT2104 in?

INT2104 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.

What clinical trials is INT2104 in?

INT2104 is being studied in a single Phase 1 clinical trial registered as NCT06539338. This trial is active but not recruiting participants, with a planned enrollment of 10 patients. The study is being conducted at sites in Australia and Spain.

Is INT2104 the same as any other drug?

INT2104 is the primary name for this investigational gene therapy. No alternative names have been associated with this drug in the available clinical trial information.