A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Zhejiang University

Status and phase

Enrolling

Phase 2

Conditions

New Diagnosis Tumor

Multiple Myeloma

Treatments

Drug: BCMA CAR-T cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05712083

IIT20210024C-R4

Details and patient eligibility

About

Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Full description

This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.