This study is a single-center, open Phase I study, to observe the effectiveness and safety of CT103A combined with different doses of Selinexor in patients with relapsed/refractory extramedullary multiple myeloma, and the pharmacokinetics of Selinexor and CT103A Kinetic and pharmacodynamic characteristics.
In this study, two dose groups of 20 mg/week and 40 mg/week will be set for Selinexor, and the dose of CT103A is 1.0×106 cells/Kg. Subjects in all dose groups will firstly receive a single dose infusion of CT103A, at least 1 month post infusion and platelet recovery to ≥50×109/L. Then subjects began to take Selinexor once a week for one year. Each dose group level will include 8-10 subjects, and a total of 16-20 subjects are expected to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Selinexor, 20 mg/tablet, is a first-in-class, oral Selective-Inhibitor-of-Nuclear-Export (SINE) compound that impedes XPO-1which is a major nuclear export protein of macromolecular cargo frequently overexpressed in MM.
CT103A consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that containing a unique CAR structure with a fully human single-chain variable fragment (scFv).
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGProgression-free survival (PFS)
The time from the start of CT103A treatment for the subjects to the first disease progression or death for any reason.
Time frame: 1 year post CT103A infusion
Objective response rate (ORR)
The percentage of subjects who achieved sCR、CR、VGPR、PR.
Time frame: 1 year post CT103A infusion
Duration of response (DOR) after administration
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria
Time frame: 1 year post CT103A infusion
Overall survival (OS)
OS is measured from the date of the initial infusion of CT103A to the date of the participant's death.
Time frame: 1 year post CT103A infusion
Minimal Residual Disease (MRD) efficacy evaluation
MRD evaluation according to IMWG, including the proportion of subjects who achieved MRD negative and the duration of MRD negative.
Time frame: 1 year post CT103A infusion
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after lymphodepletion and after infusion, those related to study drug and lymphodepletion, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity
Time frame: 1 year post CT103A infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetics - Cmax of CT103A
The maximum transgene level at Cmax fo CT103A
Time frame: 1 year post CT103A infusion
Pharmacokinetics - Tmax of CT103A
The maximum transgene level at Tmax fo CT103A
Time frame: 1 year post CT103A infusion
Pharmacokinetics - AUC0-28days of CT103A
Area under the curve of CT103A cells from time zero to Day 28 of CT103A
Time frame: 1 year post CT103A infusion
Pharmacokinetics - AUC0-90days of CT103A
Area under the curve of CT103A cells from time zero to Day 90 of CT103A
Time frame: 1 year post CT103A infusion
Pharmacokinetics of Selinexor
The changes of concentration of Selinexor in peripheral blood will be assessed.
Time frame: 1 year post CT103A infusion
PD endpoints
The concentration levels of CAR-T-related serum cytokines such as Ferritin and IL-6
Time frame: 1 year post CT103A infusion
Health-related quality of life assessment
HRQoL will be assessed by the European Organization for Cancer Research and Treatment Quality of Life Questionnaire (EORTC-QLQ-C30)
Time frame: 1 year post CT103A infusion
Appraisal of life quality
Appraisal of life quality of the subjects will be assessed by the Quality of Life Multiple Myeloma Module Questionnaire (QLQ-MY20)
Time frame: 1 year post CAR-T cell infusion
Evaluation of lymphocyte subsets
Lymphocyte subsets will be assessed by FACS
Time frame: 1 year post CAR-T cell infusion
Concentration of immunoglobulins
The levels of Immunoglobulins in peripheral blood will be assessed to monitor changes at each time point
Time frame: 1 year post CAR-T cell infusion