Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KITE-197 · 1 trial · 1 indication
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...
KITE-197 is an investigational small molecule being studied for the treatment of relapsed or refractory large B-cell lymphoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.
KITE-197 is being developed by Gilead Sciences, Inc., which is publicly traded under the ticker symbol GILD on the NASDAQ.
KITE-197 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA for any use.
KITE-197 is being studied in a Phase 1 clinical trial with the identifier NCT06079164. This trial is active but not recruiting participants and is being conducted in the United States, Australia, and Canada.
No, KITE-197 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for relapsed or refractory large B-cell lymphoma.