Overview
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Description
In this study, 60 patients with relapsed refractory multiple myeloma were proposed to undergo DeepTag-GPRC5D CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of DeepTag-GPRC5D 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 DeepTag-GPRC5D CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.
Eligibility
Inclusion Criteria:
* 1\. Those who voluntarily participated in this trial and provided informed consent;
* 2\. Gender unlimited，18\0.3×10e9/L;
2. Neutrophils ≥0.5×10e9/L;
3. Hemoglobin ≥60g/L;
4. Platelet ≥30×10e9/L
Exclusion Criteria:
* 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
* 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* 3\. Pregnant (or lactating) women;
* 4\. Patients with HIV infection;
* 5\. Active infection of hepatitis B virus or hepatitis C virus;
* 6\. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
* 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8\. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
* 9\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study;
* 10\. Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening;
* 11\. Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment;
* 12\. Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period;
* 13\. Patients received allogeneic stem cell therapy;
* 14\. Any unsuitable to participate in this trial judged by the investigator.
