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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborator: Yake Biotechnology Ltd.

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.