Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INT2104 · 1 trial · 2 indications
Number of Participants With Adverse Events as Assessed by CTCAE v5.0
Number of Participants With abnormal clinical laboratory values as Assessed by CTCAE v5.0
Number of participants experiencing Cytokine Release Syndrome (CRS)
Number of participants experiencing Immune Effector Cell Neurotoxicity (ICANS)
Number of participants experiencing dose-limiting toxicities (DLTs)
| Arm | Type | Description |
|---|---|---|
| INT2104 Dose Level 1 | EXPERIMENTAL | Single IV administration of INT2104 |
| INT2104 Dose Level 2 | EXPERIMENTAL | Single IV administration of INT2104 |
| INT2104 Dose Level 3 | EXPERIMENTAL | Single IV administration of INT2104 |
| INT2104 Dose Level 4 | EXPERIMENTAL | Single IV administration of INT2104 |
| INT2104 Recommended Dose | EXPERIMENTAL | Single IV administration of INT2104 |
| Name | Type | Description |
|---|---|---|
| INT2104 | GENETIC | INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20) |
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 *...
INT2104 is an investigational gene therapy being studied in adults with B-cell cancers, including non-Hodgkin's B-cell lymphomas and precursor cell lymphoblastic leukemia-lymphoma, that have returned after previous treatment. It is not yet approved for any indication and remains in clinical development.
INT2104 is being developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. The company is the sponsor of the clinical program evaluating the gene therapy in patients with relapsed B-cell malignancies.
INT2104 is in Phase 1 clinical development. The program has one active trial, and no trials have been completed. The Phase 1 study is designed to investigate the safety of INT2104 infusions in participants aged 18 years and older with B-cell cancers that came back after previous treatment.
INT2104 is being evaluated in the Phase 1 trial NCT06539338, titled 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. The trial is active but not recruiting, with an estimated enrollment of 10 participants across Australia and Spain.
No. INT2104 is an investigational gene therapy and has not been approved by the FDA. It is currently in Phase 1 clinical testing for relapsed B-cell cancers, including non-Hodgkin's B-cell lymphomas, and remains under study for safety and tolerability.