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Recruiting
NCT05712083
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Conditions: Multiple Myeloma, New Diagnosis Tumor
Sex: All
Phase: PHASE1
Enrollment: 40
Sponsor: Zhejiang University
Location: China
Summary
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:1.Age and gender unlimited;2.According to the IMWG2014 standard, diagnosis as multiple myeloma;3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;4.Abnormal plasmocyte BCMA expression positive;5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;6.The subject has no lung activity infection;7.Expected life time is more than 3 months;8.ECOG score 0-2 score;9.Voluntarily participate in the trial and sign the informed consent form.Exclusion Criteria:1.Patients with the history of epilepsy or other CNS disease;2.Patients with prolonged QT interval time or severe heart disease;3.Pregnant or breastfeeding;4.Active infection with no cure;5.Patients with active hepatitis B or C infection;6.Previously treated with any genetic therapy;7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;8.Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;9.Those who suffer from other uncontrolled diseases are not suitable to join the study;10.HIV infection;11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Source: ClinicalTrials.gov (NCT05712083). StuddyBuddy aggregates publicly available trial information.