Actively Recruiting
JY232(JY232) Injection in Relapsed/Refractory Multiple Myeloma
Led by Shenzhen Genocury Biotech Co., Ltd. · Updated on 2026-01-13
9
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory multiple myeloma. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY232 injection in the treatment of relapsed/refractory multiple myeloma.
CONDITIONS
Official Title
JY232(JY232) Injection in Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and willingness to comply with study requirements
- Age between 18 and 75 years, male or female
- Diagnosis of active multiple myeloma according to International Myeloma Working Group criteria
- Must have undergone stem cell transplantation or be transplant-ineligible
- At least 2 prior lines of anti-multiple myeloma therapy including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapy, with documented disease progression or relapse
- Tumor sample positive for B-Cell Maturation Antigen expression by immunohistochemistry or flow cytometry
- Measurable disease at screening by specified laboratory or clinical criteria
- Eastern Cooperative Oncology Group performance status score of 0-2
- Expected survival time of at least 12 weeks
- Adequate organ function based on specific hematology, liver, renal, coagulation, oxygen saturation, and cardiac function tests
- Agreement to use effective contraception from consent signing until one year after CAR-T cell infusion
You will not qualify if you...
- History of graft-versus-host disease, autoimmune disease, immunodeficiency, or need for long-term immunosuppressive therapy
- Allogeneic stem cell transplant within 6 months or autologous stem cell transplant within 3 months prior to infusion
- Recent prior anti-tumor therapies including monoclonal antibodies, chemotherapy, proteasome inhibitors, immunomodulatory agents, investigational drugs, or radiotherapy within defined timeframes before dosing
- Use of high-dose corticosteroids within 7 days before screening (except certain exceptions)
- Uncontrolled hypertension or hypotension
- Severe cardiac disease including recent myocardial infarction or severe heart failure
- Unstable systemic diseases requiring medication
- Other malignancies within 5 years except certain treated cancers
- History of solid organ transplantation
- Central nervous system involvement or metastasis
- Extramedullary disease beyond specified limits
- Concomitant plasma cell leukemia
- Major surgery within 2 weeks before or after dosing
- Treatment with other investigational drugs within 1 month prior to consent
- Uncontrolled active infection within 7 days before dosing
- Positive for certain viral infections including hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis
- Pregnant or breastfeeding women
- Psychiatric illness or central nervous system disorders
- Unresolved toxicities from prior therapy above specified grades
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Foshan First People's Hospital
Foshan, Guangdong, China
Actively Recruiting
Research Team
Y
Ying Zhao, Doctor
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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