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 inflammatory neuropathy cause and treatment (INCAT) scale. The INCAT score is a clinician administered tool used to assess functional disability in participants with 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) | 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 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 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: * Reproductive status-related eligibility and contraception requirements: * Participants must agree to use protocol-specified method(s) of contraception where applicable Inclusion Criteria for multiple sclerosis (MS): MS (Relapsing and progressive forms): * Diagnosed w...
KITE-363 is an investigational monoclonal antibody being studied for Chronic Inflammatory Demyelinating Polyneuropathy, Systemic Lupus Erythematosus, and Relapsed and/or Refractory B-cell Lymphoma. It is also being evaluated in related autoimmune conditions including Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy, Myasthenia Gravis, and Multiple Sclerosis.
KITE-363 targets CD19, an antigen found on B cells. By binding to CD19, the antibody is designed to engage B cells involved in autoimmune diseases and B-cell malignancies. This mechanism is being investigated across neurologic, rheumatologic, and oncologic indications in early-phase clinical trials.
KITE-363 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The company is sponsoring multiple Phase 1 clinical trials evaluating the drug in autoimmune and oncologic indications.
KITE-363 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 1 trials are currently active, with one recruiting participants for B-cell lymphoma and others enrolling or recruiting for autoimmune diseases.
KITE-363 is being studied in three Phase 1 trials. NCT04989803 evaluates it in relapsed and/or refractory B-cell lymphoma with 247 participants. NCT07038447 studies it in refractory autoimmune diseases including lupus and scleroderma. NCT07304154 examines it in autoimmune neurologic diseases such as chronic inflammatory demyelinating polyneuropathy.
KITE-363 is distinct from KITE-753, though both are being studied together in a clinical trial for relapsed and/or refractory B-cell lymphoma. The trial NCT04989803 evaluates KITE-363 or KITE-753 in separate arms, indicating they are different investigational agents being compared within the same study.