Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06539338 | 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 | PHASE1 | ACTIVE NOT_RECRUITING | 10 | — | — | Sep 20, 2024 | Jul 1, 2026 | Apr 24, 2026 | 3 | Australia, Spain |
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 *...