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 range
18 Years
Sex
ALL
See this in plain English?
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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).