Tests modified immune cells against myeloma that returned or stopped responding
Tests BCMA-targeted CAR-T cells in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Source: NCT04670055, who can take part
Where in China
- The First Affiliated Hospital, Medical College, Zhejiang UniversityHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT04670055
- Record updated
- 17 December 2020
- Original description
Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myelomaRead full original descriptionShow less
Clinical Trial for the Safety and Efficacy of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
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: 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; History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Subjects with any of the following exclusion criteria were not eligible for this trial:; Pregnant (or lactating) women; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.