Multiple Myeloma, New Diagnosis Tumor
Conditions
Keywords
BCMA CAR-T, Multiple Myeloma, New Diagnosis
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
Interventions
DRUGBCMA CAR-T cells
Each subject receive BCMA CAR T-cells by intravenous infusion
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
Countries
China
Contacts
Primary ContactHe Huang, MD
Backup ContactMingming Zhang, MD
Outcome results
None listed