Clinical trial NCT05712083: A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Official title: Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
New Diagnosis Tumor
Keywords: BCMA CAR-T
Multiple Myeloma
New Diagnosis
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yake Biotechnology Ltd.
First posted: 2023-02-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Baseline up to 28 days after BCMA CAR T-cells infusion
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline up to 2 years after BCMA CAR T-cells infusion
Secondary outcomes:
measure: Multiple Myeloma (MM), Overall response rate (ORR)
timeFrame: At Month 1, 3, 6, 12, 18 and 24
measure: Complete response rate(CRR)
timeFrame: Baseline up to 2 years after BCMA CAR T-cells infusion
measure: Partial response Rate (PRR)
timeFrame: Up to 2 years after BCMA CAR T-cells infusion
measure: Overall survival
timeFrame: Up to 2 years after BCMA CAR T-cells infusion
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: He Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: