None listed
Conditions
Brief summary
KITE-363 is an exploratory treatment for autoimmune neurological diseases such as multiple sclerosis, myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. KITE-363 utilizes a patient's own T-cells, which are genetically modified to target and eliminate pathogenic, harmful cells, KITE-363 aims to reduce the effects of autoimmune neurologic diseases
Interventions
This is an open-label, basket study meaning this study includes participants who have been diagnosed with different illnesses but who will all receive the same treatment and have the same outcomes assessed. Safety and efficacy of Kite-363 will be evaluated in participants with Multiple Sclerosis, Myasthenia Gravis or Chronic Inflammatory Demyelinating Polyneuropathy.
Participants will firstly undergo leukapheresis to obtain leukocytes, from which the participant’s T cells will be used to manufa
This is an open-label, basket study meaning this study includes participants who have been diagnosed with different illnesses but who will all receive the same treatment and have the same outcomes assessed. Safety and efficacy of Kite-363 will be evaluated in participants with Multiple Sclerosis, Myasthenia Gravis or Chronic Inflammatory Demyelinating Polyneuropathy. Participants will firstly undergo leukapheresis to obtain leukocytes, from which the participant’s T cells will be used to manufacture KITE-363. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine on Day 5 through Day 3 prior to infusion of KITE-363. Treatment will consist of a single infusion of CAR-transduced autologous T cells (KITE-363) administered intravenously. The dose escalation levels for Kite 363 are as follows: 0.5 x 10^6 & 1.0 x 10^6 Kite-363 Cells/kg. Both the first and second cohorts of participants may include participants from any of the indicated diseases mentioned above. Up to 12 participants will be enrolled in the first cohort and will be treated at sequential dose-escalation levels and assessed for dose limiting toxicities (DLTs). Administration of Kite-363 will be staggered to allow for observation of toxicities. 4 weeks after the first cohort is dosed with 0.5 x 10^6 Kite-363 Cells/kg, if the dose limiting toxicities observed do not cross the study-specific thresholds then the next dose level (1.0 x 10^6 Kite-363 Cells/kg) cohorts will be dosed. Based on dose limiting toxicities (DLTs) observed in the first cohort of participants and in assessment of the recommended KITE-363 dose, additional participants will be enrolled and administered escalating doses of KITE-363 to further characterise the efficacy and safety profile. During this dose-expansion portion of the study, indication specific cohorts will also be used. Participants will be dosed at treatment centres by medical staff specially trained on the product.
Sponsors
Kite, A Gilead Company
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria or Diagnosis of MG with generalized weakness meeting criteria as defined by the MGFA classification of II-IV at screening or Diagnosed with probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) These criteria are not exhaustive, other protocol defined Inclusion/Exclusion criteria may apply. A member of the research team will provide further details at the time of screening and enrolment.
Exclusion criteria
1) Bone marrow insufficiency within 28 days of lymphodepletion 2) History of autologous or allogeneic stem cell transplant and/or organ transplant 3) Prior treatment with cellular therapy, gene therapy and/or T-cell engager therapy These criteria are not exhaustive, other protocol defined Inclusion/Exclusion criteria may apply. A member of the research team will provide further details at the time of screening and enrolment.
Outcome results
None listed