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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)
Biological/Vaccine
This is dose level 0 (de-escalation).
BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)
Biological/Vaccine
This is dose level 1, the starting dose.
BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
Biological/Vaccine
This is dose level 2.
BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)
Biological/Vaccine
This is dose level 3.
Maximum tolerated dose
Biological/Vaccine
The maximum tolerated dose is yet to be determined.

Treatment groups

30 Participants

are divided into 5 treatment groups

Group 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

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 infusion

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: