Study to Evaluate the Safety of UF-KURE-BCMA CAR T-Cells in Advanced Myeloma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKure Cells, INC
About this trial
The goal of this study is to evaluate the safety of a new type of CAR T-cell, UF-KURE-BCMA, for the treatment of patients with advanced multiple myeloma that has not responded to other therapies. The main question is whether the use of these new CAR T-cells is safe for patients with this condition. Secondarily, the study will also look at the response of myeloma to this therapy.
Eligibility criteria
Qualifiers
Age: ≥18 years at time of signing informed consent
Relapsed disease: Progression after achieving at least minimal response (MR) to prior therapy
Refractory disease: Non-responsive or progressive disease while on therapy or within 60 days of last treatment (in subjects who achieved ≥MR on prior therapy)
Received ≥3 prior lines of anti-myeloma therapy
Disqualifiers
Active CNS involvement by multiple myeloma
Plasma cell leukemia
History of allogeneic hematopoietic stem cell transplantation
New York Heart Association (NYHA) Class IV congestive heart failure
Trial design
Treatments tested in this trial
- Administration of CAR T-cells at 3 different dose levels
Treatment groups
12 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov