Multiple Myeloma Clinical Trial
Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)
This is a Phase I, FIH, open-label, dose escalation study evaluating Safety and Efficacy of UCART targeting CS1 in patients with Relapsed or Refractory Multiple Myeloma (MM). The purpose of this study is to evaluate the safety and clinical activity of UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).
Patients with confirmed diagnosis of active multiple myeloma (as defined by International Myeloma Working Group [IMWG] criteria) who have relapsed/refractory disease after and have received at least 3 prior lines of prior therapy.
Eastern Cooperative Oncology Group Performance Status of 0 or 1;
No previous treatment with investigational gene targeting CS1 or chimeric antigen receptor therapy targeting CS1
Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the screening period.
Other criteria may apply.
Previous treatment with investigational gene therapy targeting CS1 or chimeric antigen receptor therapy targeting CS1;
Any cellular therapy (other than autologous or allogenic HSCT) within 60 days prior to enrollment;
Prior treatment with rituximab or other anti-CD20 therapy within 3 months
Any known active or uncontrolled infection
Autologous hematopoietic stem cell transplantation (HSCT) within 12 weeks prior to enrollment; any cellular therapy (other than autologous) within 60 days prior to enrollment; prior allogeneic HSCT.
Seropositive for Hepatitis C virus or positive for Hepatitis B surface antigen or core antibody.
Presence of active and clinically relevant central nervous system disorder, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.
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There are 8 Locations for this study
San Francisco California, 94115, United States
Denver Colorado, 80218, United States
Atlanta Georgia, 30322, United States
Rochester Minnesota, 55905, United States
Hackensack New Jersey, 07601, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
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