Actively Recruiting
A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies
Led by Sinocelltech Ltd. · Updated on 2024-04-22
74
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies
CONDITIONS
Official Title
A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older and weighing between 40 and 90 kg
- Diagnosed with relapsed or refractory CD38+ hematologic malignancies confirmed by immunohistochemistry or flow cytometry
- Have failed standard therapies or have no available or tolerable standard treatment options
- Have at least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of 3 months or more
- Have basically normal liver, kidney, and heart functions
- Hematology values meeting: platelet count ≥ 75x10^9/L, absolute neutrophil count ≥ 1.0x10^9/L, hemoglobin ≥ 8.0 g/dL
- Women of childbearing potential must have a negative blood pregnancy test within 7 days before the first dose
- Male and female participants must use effective contraception from consent until 5 months after last dose
- No sperm or egg donation during the study and for 5 months after last dose
You will not qualify if you...
- History of allergic reactions to SCTC21C or its components, or severe drug allergy history
- Received other antineoplastic drugs (except hormones) or radiotherapy within 4 weeks before first dose
- Received immunotherapy or anti-CD38 monoclonal antibodies within 6 months prior to first dose
- Unresolved adverse events from prior treatments greater than Grade 1
- Prior immunotherapy with Grade 3 or higher cytokine release syndrome
- Central nervous system involvement
- Positive HIV antibody test
- Positive HBsAg with high HBV-DNA or positive HCV antibody with high HCV-RNA exceeding test limits
- Active infections requiring systemic treatment within 1 week before first dose
- History of additional malignant tumors, active autoimmune diseases, or serious medical conditions
- Major surgery within 4 weeks before first dose or planned surgery during study
- History of allogeneic hematopoietic stem cell or solid organ transplantation, or autologous hematopoietic stem cell transplant within 6 months
- Significant digestive system dysfunction affecting drug absorption
- Received live vaccines within 30 days before first dose
- Mental disorders or poor compliance
- Female participants who are breastfeeding
- Investigator determines participant is ineligible for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Chaoyang Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Q
Qiang Zhou
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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