Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)
Biological/VaccineThis is dose level 0 (de-escalation).
BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)
Biological/VaccineThis is dose level 1, the starting dose.
BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
Biological/VaccineThis is dose level 2.
BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)
Biological/VaccineThis is dose level 3.
Maximum tolerated dose
Biological/VaccineThe maximum tolerated dose is yet to be determined.
Treatment groups
30 Participants
are divided into 5 treatment groupsGroup A: BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)Experimental treatment 1 intervention
Group B: BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)Experimental treatment 1 intervention
Group C: BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)Experimental treatment 1 intervention
Group D: BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)Experimental treatment 1 intervention
Group E: BCMA-TGFβ CAR-T cells (Maximum tolerated dose)Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Number of Adverse Events After BCMA-TGFβ CAR-T Cell Infusion
Incidence of adverse events with grade 3 to 5 severity using NCI CTCAE version 5.0 and the Lee et al. consensus manuscript (which outlines the defining characteristics of each grade for cytokine release syndrome; please refer to the reference below).
Time frame
from infusion until Day +28 post CAR T infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov