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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712083
• Other study ID #: IIT20210024C-R4
• Status: Recruiting
• Phase: Phase 2
• Start date: January 30, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2023
• Source: Zhejiang University
• Contact: He Huang, MD
• Phone: 86-13605714822
• Email: hehuangyu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• New Diagnosis Tumor

Intervention

Drug:
• BCMA CAR-T cells
Each subject receive BCMA CAR T-cells by intravenous infusion

Locations

Country	Name	City	State
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Yake Biotechnology Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)	Adverse events assessed according to NCI-CTCAE v5.0 criteria	Baseline up to 28 days after BCMA CAR T-cells infusion
Primary	Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events [Safety and Tolerability]	Baseline up to 2 years after BCMA CAR T-cells infusion
Secondary	Multiple Myeloma (MM), Overall response rate (ORR)	Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24	At Month 1, 3, 6, 12, 18 and 24
Secondary	Complete response rate(CRR)	Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)	Baseline up to 2 years after BCMA CAR T-cells infusion
Secondary	Partial response Rate (PRR)	Proportion of subjects who achieved a partial response (PR)	Up to 2 years after BCMA CAR T-cells infusion
Secondary	Overall survival	Death from any cause from the beginning of cell transfusion	Up to 2 years after BCMA CAR T-cells infusion