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

Study Overview
=================
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

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

Conditions
-----------------
Multiple Myeloma, New Diagnosis Tumor

Intervention / Treatment
-----------------
* Drug: BCMA CAR-T cells


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>This is a single arm clinical trial. | Drug: BCMA CAR-T cells<br>* Each subject receive BCMA CAR T-cells by intravenous infusion<br>* Other names: BCMA CAR-T cells injection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Partial response Rate (PRR) | Proportion of subjects who achieved a partial response (PR) | Up to 2 years after BCMA CAR T-cells infusion | 
| Overall survival | Death from any cause from the beginning of cell transfusion | Up to 2 years after BCMA CAR T-cells infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, New Diagnosis, BCMA CAR-T