Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN. (NCT04109482) | Clinical Trial Compass
TerminatedPhase 1/2
Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN.
Stopped: Business reasons.
United States3 participantsStarted 2020-02-17
Plain-language summary
A phase 1/2 study to assess the safety and efficacy of MB-102 in patients with relapsed or refractory BPDCN
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with a diagnosis of BPDCN according to WHO classification (Arber et al., 2016) confirmed by hematopathology and histological/cytological evidence of BPDCN in the peripheral blood, bone marrow, spleen, lymph nodes, skin and/or other sites who have failed one prior therapy.
✓. Male and female patients ≥ 18 years of age at the time of consent.
✓. Written informed consent in accordance with federal, local, and institutional guidelines.
✓. Must be able to adhere to the study visit schedule and other protocol requirements.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Meet the following laboratory criteria:
✓. Cardiac ejection fraction ≥ 45%, with no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or if not available, a multigated acquisition scan (MUGA).
✓. Females participants of childbearing potential must have a negative serum test.
Exclusion criteria
✕. Patients with a corticosteroid dependence on doses greater than physiological replacement i.e., prednisone no more than 7.5 mg/day or hydrocortisone less than 12mg/m2/day.
✕. Contraindication or hypersensitivity to fludarabine or cyclophosphamide.
✕. Hypersensitivity or known history of allergic reactions attributed to tocilizumab, Cetuximab, or other anti-EGFR -monoclonal antibodies.
What they're measuring
1
Phase 1: Safety and Tolerability as measured by the number of patients with treatment related adverse events
Timeframe: 28 Days
2
Phase 1: Maximum Tolerated Dose (MTD) and recommended Phase 2 dose
✕. Immunotherapy treatments within 28 days prior to leukapheresis.
✕. Previous treatment with anti-CD123 CAR-T treatment.
✕. Previous treatment with any other antileukemic or investigational agent within 7 days of leukapheresis.
✕. Patients with history or active seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement.
✕. Patients with known CNS leukemic involvement that are refractory to intrathecal chemotherapy and/or cranio-spinal radiation that have NOT been effectively treated to complete remission (defined as \< 5 WBC/mm3 and no blasts in CSF).