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Trial Title:
A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
NCT ID:
NCT06084962
Condition:
Relapse/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
DeepTag-GPRC5D CAR T-cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
DeepTag-GPRC5D Targeted CAR T-cells
Description:
Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion
Arm group label:
Administration of DeepTag-GPRC5D Targeted CAR T-cells
Other name:
DeepTag-GPRC5D Targeted CAR T-cells injection
Summary:
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy
for refractory/relapsed multiple myeloma
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Those who voluntarily participated in this trial and provided informed consent;
-
2. Gender unlimited，180.3×10e9/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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of medical college of zhejiang university
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, MD
Phone:
86-13605714822
Email:
hehuangyu@126.com
Contact backup:
Last name:
Yongxian Hu, MD
Phone:
+8615957162012
Email:
huyongxian2000@aliyun.com
Start date:
October 20, 2023
Completion date:
October 20, 2026
Lead sponsor:
Agency:
He Huang
Agency class:
Other
Collaborator:
Agency:
Yake Biotechnology Ltd.
Agency class:
Industry
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06084962
