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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06079164 | Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma | PHASE1 | ACTIVE NOT_RECRUITING | 39 | — | — | Nov 9, 2023 | Jul 1, 2026 | Jan 8, 2026 | 11 | United States, Australia +1 |
Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
| Arm | Type | Description |
|---|---|---|
| KITE-197 | EXPERIMENTAL | Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-197 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-197. Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable. |
| Name | Type | Description |
|---|---|---|
| KITE-197 | DRUG | A single infusion of CAR-transduced autologous T cells administered intravenously |
| Cyclophosphamide | DRUG | Lymphodepleting chemotherapy administered intravenously |
| Fludarabine | DRUG | Lymphodepleting chemotherapy administered intravenously |
Key Inclusion Criteria: * Relapsed or Refractory Large B-cell Lymphoma * At least 1 measurable lesion * Adequate organ and bone marrow function Key Exclusion Criteria: * History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free...