Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma
ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical College of Wisconsin
About this trial
This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and efficacy of interleukin-7(IL-7) / interleukin-15 (IL-15) manufactured CAR T cells in adult patients with relapsed and/or refractory myeloma that have failed prior therapies.
Eligibility criteria
Qualifiers
Patients must be aged ≥18 years to 80 years old.
Serum M-protein ≥0.5 g/dl;
Urine M-protein ≥200 mg/24 hrs;
Involved serum light chain ≥100 mg/L with abnormal light chain ratio;
Disqualifiers
Positive beta- Human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per the Schedule of Events table.
Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as >20 mg of prednisone or equivalent daily.
Presence of ≥ Grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.
Trial design
Treatments tested in this trial
- BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)
- BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)
- BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
- BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)
- Maximum tolerated dose
Treatment groups
30 Participants
are divided into 5 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov