A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCMA Targeted CAR T-cells.
- Who it may be relevant to
- Registry conditions: Relapse Multiple Myeloma, Refractory Multiple Myeloma. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Trial for the Safety and Efficacy of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Overview
Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Detailed description
This is a single arm, open-label, single-center study. This study is indicated for relapsed BCMA+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 50 patients will be enrolled for this trial. Primary objective is to explore the safety, main consideration is dose-related safety.
Interventions
- Drug BCMA Targeted CAR T-cells
Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
Primary outcome measures
- Dose-limiting toxicity (DLT) [Time frame: Baseline up to 28 days after BCMA targeted CAR T-cells infusion]
- Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after BCMA targeted CAR T-cells infusion]
Secondary outcome measures (6)
- Overall response rate (ORR) [Time frame: At Day 28]
- Overall survival (OS) [Time frame: At Month 6, 12, 24]
- Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30) [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
- Instrumental Activities of Daily Living (IADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
- Activities of Daily Living (ADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
- Hospital Anxiety and Depression Scale (HADS) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
Eligibility criteria
Inclusion criteria
- Histologically confirmed diagnosis of multiple myeloma (MM):
- Patients with BCMA positive relapsed/refractory MM;
- Relapsed after hematopoietic stem cell transplantation;
- Cases with recurrent positive minimal residual disease;
- Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
- Anticipated survival time more than 12 weeks;
- Male or female aged 30-75 years;
- Those who voluntarily participated in this trial and provided informed consent.
Exclusion criteria
Subjects with any of the following exclusion criteria were not eligible for this trial:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital, Medical College, Zhejiang University — Hangzhou
Publications
- Chen R, Jin C, Liu K, Zhao M, Yang T, Zhang M, Xiao P, Feng J, Hong R, Fu S, Cui J, Huang S, Wei G, Huang H, Hu Y. Predictive value of pre-treatment circulating tumor DNA genomic landscape in patients with relapsed/refractory multiple myeloma undergoing anti-BCMA CAR-T therapy: Insights from tumor cells and T cells. Chin Med J (Engl). 2025 Oct 5;138(19):2481-2490. doi: 10.1097/CM9.0000000000003306 PMID 39501801
Identifiers
NCT: NCT04670055 · hBCMA-ZhejiangU