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

Phase 2

Recruiting

• Conditions: New Diagnosis Tumor; Multiple Myeloma
• Interventions: Drug: BCMA CAR-T cells

• Registration Number: NCT05712083
• Lead Sponsor: Zhejiang University

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

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-30
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-03
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	BCMA CAR-T cells	This is a single arm clinical trial.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Baseline up to 28 days after BCMA CAR T-cells infusion	Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)	Baseline up to 2 years after BCMA CAR T-cells infusion	Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Secondary Outcome Measures

Name	Time	Method
Multiple Myeloma (MM), Overall response rate (ORR)	At Month 1, 3, 6, 12, 18 and 24	Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24
Partial response Rate (PRR)	Up to 2 years after BCMA CAR T-cells infusion	Proportion of subjects who achieved a partial response (PR)
Overall survival	Up to 2 years after BCMA CAR T-cells infusion	Death from any cause from the beginning of cell transfusion
Complete response rate(CRR)	Baseline up to 2 years after BCMA CAR T-cells infusion	Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)

Trial Locations

Locations (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China