Actively Recruiting
A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Led by He Huang · Updated on 2023-10-16
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
He Huang
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
CONDITIONS
Official Title
A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide informed consent
- Any gender, age between 18 and 75 years
- Estimated life expectancy of at least 12 weeks
- ECOG performance status of 0 to 2
- Diagnosed with multiple myeloma according to IMWG criteria
- Failed at least 3 prior lines of therapy including proteasome inhibitors, immunomodulatory agents, and CD38 antibody, with disease progression or recurrence during or within 6 months after treatment
- Women must have a negative urine pregnancy test before treatment and agree to use effective contraception during the trial until last follow-up
- Blood counts must meet these minimum levels: lymphocytes >0.3 x10e9/L, neutrophils ≥0.5 x10e9/L, hemoglobin ≥60 g/L, platelets ≥30 x10e9/L
You will not qualify if you...
- History of brain injury, unconsciousness, epilepsy, cerebrovascular ischemia, or hemorrhage
- Prolonged QT interval on ECG or severe heart disease including severe arrhythmia
- Pregnant or lactating women
- HIV infection
- Active hepatitis B or C infection
- Use of systemic steroids within 2 weeks before screening, except inhaled steroids
- Proliferation rate less than 5 times response to CD3/CD28 stimulation
- Creatinine >2.5 mg/dl, ALT/AST >3 times normal, or bilirubin >2.0 mg/dl
- Any condition increasing risk or interfering with study results as judged by investigator
- Anti-cancer chemotherapy or other medications within 2 weeks before screening
- Uncontrolled malignant tumors other than multiple myeloma, except treated tumors with no active disease for 3 years
- Autologous stem cell transplant within 8 weeks before screening or planned during study
- Received allogeneic stem cell therapy
- Any other condition making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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