Clinical Trial for the Safety and Efficacy of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Relapse Multiple Myeloma
- Sponsor
- Zhejiang University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Clinical Trial for the safety and efficacy of BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Detailed Description
In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.
Investigators
He Huang
Clinical Professor
Zhejiang University
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;
- •Repeated MRD(+) refractory resistant cases
- •Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
- •Anticipated survival time more than 12 weeks;
- •Transplant patients, regardless of their previous treatment, are eligible after relapse;
- •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;
- •With a graft-versus-host response, immunosuppressants are required;
- •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;
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after BCMA targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Dose-limiting toxicity (DLT)
Time Frame: Baseline up to 28 days after BCMA targeted CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Secondary Outcomes
- Activities of Daily Living (ADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- Overall response rate (ORR)(At Day 28)
- Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)(At Baseline, Month 1, 3, 6, 9 and 12)
- Hospital Anxiety and Depression Scale (HADS) score(At Baseline, Month 1, 3, 6, 9 and 12)
- Overall survival (OS)(At Month 6, 12, 24)
- Instrumental Activities of Daily Living (IADL) score(At Baseline, Month 1, 3, 6, 9 and 12)