Status:
UNKNOWN
A Study of a Fully Human BCMA-targeting CAR (CT103A) Combined With Selinexor in Patients With Relapsed/Refractory Extramedullary Multiple Myeloma
Lead Sponsor:
Chunrui Li
Collaborating Sponsors:
Nanjing IASO Biotechnology Co., Ltd.
Conditions:
Extramedullary Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 mult...
Detailed Description
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 infusi...
Eligibility Criteria
Inclusion
- Subjects must satisfy all the following criteria to be enrolled in the study:
- age ≥18 years old, male or female.
- Subjects with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 3 prior lines of therapy
- Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue(e.g., bone marrow biopsies, or plasmacytoma).
- Subjects with extramedullary myeloma require extramedullary lesions with a maximum diameter of ≥2cm
- ECOG score is ≤ 2
- Estimated life expectancy ≥ 12 weeks.
- Subjects should have adequate organ function:
- <!-- -->
- Absolute neutrophil count (ANC) ≥1×10\^9 /L; absolute lymphocyte count (ALC) ≥0.3×10\^9 /L; platelets ≥50×10\^9 /L; hemoglobin ≥60 g/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.
- Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml/min.
- Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.
- SpO2 \> 91%.
- Left ventricular ejection fraction (LVEF) ≥ 50%. 8. The subject and his/her spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) from the date of the subject's informed consent to one year post CAR T cell infusion.
- 9\. Subject must sign the informed consent form approved by the ethics board in person before starting any screening procedure.
Exclusion
- The presence of any of the following will exclude a subject from enrollment:
- Subjects who are known to be resistant to Selinexor;
- Subjects who need to use immunosuppressive agents for a long time due to graft-versus-host disease (GVHD) or autoimmune diseases.
- Subjects have received any anti-cancer treatment as follows: monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis, or anti-tumor treatments other than those listed above within 30 days before leukapheresis.
- Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.
- Subjects with hypertension that cannot be controlled by medication
- Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.
- Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.
- Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.
- Subjects with a history of organ transplantation.
- Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia)
- Subjects participated in another interventional clinical study within 1 month before signing the informed consent (ICF).
- Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis.
- Positive for any of the following tests:
- Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood
- Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood
- Human immunodeficiency virus (HIV) antibody
- Cytomegalovirus (CMV) DNA
- Treponema Pallidum antibody
- Pregnant or lactating women.
- Subjects with mental illness or consciousness disorder or disease of the central nervous system
- Other conditions that researchers consider inappropriate for enrollment.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05201118
Start Date
January 1 2022
End Date
December 31 2023
Last Update
May 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000