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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Administration of CAR T-cells at 3 different dose levels
Biological/VaccineThe patients will receive one of 3 dose levels as outlined above.
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: Lower Dose LevelActive comparator 1 intervention
Group B: Starting Dose LevelActive comparator 1 intervention
Group C: Higher Dose LevelActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicities (DLT occurring within 28 days of CAR-T cell infusion)
DLT
Time frame
Within 28 days of CAR-T cell infusionSecondary outcomes
1
Manufacturing success rate
Manufacturing success rate is defined as manufacturing process leading to an adequate product per protocol standards. We expect this outcome to occur in ≥75% of the products manufactured.
Time frame
28 days post infusion2
Treatment-emergent adverse events
Treatment adverse events related to the administration of CART-cells
Time frame
At 24 months3
ORR per IMWG criteria
Overall response rate
Time frame
At 24 months4
DOR
Duration of Response
Time frame
At day 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: