Status:
NOT_YET_RECRUITING
A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Yake Biotechnology Ltd.
Conditions:
Relapse Multiple Myeloma
Refractory Multiple Myeloma
Eligibility:
All Genders
30-75 years
Phase:
EARLY_PHASE1
Brief Summary
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 trial...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04670055
Start Date
January 1 2021
End Date
January 1 2027
Last Update
December 17 2020
Active Locations (1)
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1
The First Affiliated Hospital, Medical College, Zhejiang University
Hangzhou, Zhejiang, China, 310003