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

NCT ID: NCT05712083

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2024-04-01

Brief Summary

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

Detailed 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

Conditions

Multiple Myeloma; New Diagnosis Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

This is a single arm clinical trial.

Group Type: EXPERIMENTAL

BCMA CAR-T cells

Intervention Type: DRUG

Each subject receive BCMA CAR T-cells by intravenous infusion

Interventions

BCMA CAR-T cells

Each subject receive BCMA CAR T-cells by intravenous infusion

Intervention Type: DRUG

Other Intervention Names

BCMA CAR-T cells injection

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD

Role: CONTACT

hehuangyu@126.com

86-13605714822

Mingming Zhang, MD

Role: CONTACT

mingmingzhang@zju.edu.cn

13656674208

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

86-13605714822

Mingming Zhang, MD

Role: backup

mingmingzhang@zju.edu.cn

13656674208

Other Identifiers

IIT20210024C-R4

Identifier Type: -

Identifier Source: org_study_id