Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KITE-363 · 3 trials · 8 indications
This will be reported in participants with relapsing forms of Multiple Sclerosis MS (RRMS) and (aSPMS).
The MG-ADL is a scale to measure the functional impact of MG on daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability and disease burden.
Clinical improvement will be analyzed using adjusted inflammatory neuropathy cause and treatment (aINCAT) scale. The INCAT score is a clinician administered tool used to assess functional disability in participants with chronic inflammatory demyelinating polyneuropathy (CIDP). The total scores range from 0 to 10, higher scores indicating greater disability and lower score would indicate clinical improvement.
DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.
ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: KITE-363 (Dose Escalation) With Lymphodepleting Chemotherapy | EXPERIMENTAL | Participants with relapsing forms of multiple sclerosis (RMS), progressive forms of multiple sclerosis (PMS), myasthenia gravis (MG), and/or chronic inflammatory demyelinating polyneuropathy (CIDP) will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by infusion of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells at a single dose level, with different participants receiving sequential dose-escalation levels to find the Phase 1b recommended dose. |
| Phase 1a: KITE-363 (Dose Escalation) Without Lymphodepleting Chemotherapy | EXPERIMENTAL | Participants with RMS, PMS, MG, and/or CIDP will receive infusion of KITE-363 CAR transduced autologous T cells at a single dose level, with different participants receiving sequential dose-escalation levels to find the Phase 1b recommended dose. |
| Phase 1b: KITE-363 (Dose Expansion) | EXPERIMENTAL | Participants with RMS, PMS, MG, and/or CIDP will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1a recommended dose of KITE-363 CAR T cells. |
| Phase 1a: KITE-363 (Dose Escalation) | EXPERIMENTAL | Participants with refractory autoimmune diseases will receive lymphodepleting chemotherapy followed by different doses of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells to find the Phase 1b recommended dose. |
| Phase 1 a/b: KITE-363 | 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-363 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-363. 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-363 at 1 or more dose-level deemed to be tolerable. \[Recruitment completed for this arm\] |
| Phase 1 a/b: KITE-753 | 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-753 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-753. 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-753 at 1 or more dose-level deemed to be tolerable. \[Recruitment open for frontline LBCL and r/r MCL for this arm\] |
| Phase 2: KITE-753 | EXPERIMENTAL | Participants with r/r large B-cell lymphoma who have received at least 2 prior lines of systemic therapy will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells /kg intravenously (IV). |
| Name | Type | Description |
|---|---|---|
| KITE-363 | BIOLOGICAL | A single infusion of CAR-transduced autologous T cells administered as intravenous infusion. |
| Fludarabine | DRUG | Administered intravenously |
| Cyclophosphamide | DRUG | Administered intravenously |
| KITE-753 | BIOLOGICAL | A single infusion of CAR-transduced autologous T cells administered intravenously |
Key Inclusion Criteria: * Age 18 through 65 for relapsing forms of MS, 18 through 75 for progressive forms of MS, above 18 years of age for MG and CIDP. * Reproductive status-related eligibility and contraception requirements: * Individuals must agree to use protocol-specified method(s) of contr...
KITE-363 is an investigational monoclonal antibody that targets CD19, developed by Gilead Sciences, Inc. (ticker GILD). It is in Phase 1 clinical development and is being studied in autoimmune neurologic diseases, refractory autoimmune diseases, and relapsed and/or refractory B-cell lymphoma. It has not been approved by the FDA.
KITE-363 targets CD19, a B-cell surface antigen. By binding CD19, the antibody is designed to engage B cells that express this antigen. CD19 is the molecular target of KITE-363, and the program is being studied across B-cell lymphoma and several autoimmune conditions in Phase 1 trials.
KITE-363 is developed by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is running the Phase 1 clinical program for KITE-363 across lymphoma and autoimmune indications, with study sites in the United States, Australia, Canada, Europe, and South Korea.
KITE-363 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program includes studies in relapsed and/or refractory B-cell lymphoma and in autoimmune conditions such as chronic inflammatory demyelinating polyneuropathy and systemic lupus erythematosus.
KITE-363 is being studied in three Phase 1 trials: NCT07304154 in autoimmune neurologic diseases including chronic inflammatory demyelinating polyneuropathy, myasthenia gravis, and multiple sclerosis; NCT07038447 in refractory autoimmune diseases such as systemic lupus erythematosus and lupus nephritis; and NCT04989803 in relapsed and/or refractory B-cell lymphoma.
KITE-363 is being studied in relapsed and/or refractory B-cell lymphoma in a Phase 1 trial, NCT04989803, which also evaluates KITE-753. That study is recruiting with an enrollment of 247 participants across the United States, Australia, Canada, Germany, the Netherlands, and the United Kingdom. KITE-363 remains investigational.