Actively Recruiting
A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies
Led by Sinocelltech Ltd. · Updated on 2024-04-22
74
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SCTC21C, a biological treatment, in patients with relapsed or refractory CD38-positive hematologic malignancies. This multicenter, open-label Phase I trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and immune response to SCTC21C. The study includes a dose-finding stage to determine safe dosage levels and a dose-expansion stage to further evaluate selected doses. In the dose-finding stage, participants receive increasing doses of SCTC21C ranging from 0.01 mg up to 960 mg. In the dose-expansion stage, at least 20 participants are randomly assigned in a 1:1 ratio to receive two different doses determined from the earlier stage. SCTC21C is given by subcutaneous injection weekly for the first two cycles, then every two weeks for cycles three to six, and every four weeks thereafter until disease progression or unacceptable side effects occur. Participants will be closely monitored throughout the study with assessments including safety evaluations, adverse event tracking up to 45 days after the last dose, and measuring dose-limiting toxicities during the first 28-day cycle. Researchers will also evaluate tumor response over about one year of treatment. The study expects participants to have regular visits for treatment and monitoring, with the total duration varying depending on individual response and tolerability.
CONDITIONS
Brief 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, weighing between 40 and 90 kg
- Diagnosed with relapsed or refractory CD38-positive hematologic malignancies confirmed by immunohistochemistry or flow cytometry
- Standard therapies have failed, are unavailable, or intolerable
- Have at least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Life expectancy of at least 3 months
- Basically normal liver, kidney, and heart functions
- Hematology values: platelet count ≥ 75 x10^9/L, absolute neutrophil count ≥ 1.0 x10^9/L, hemoglobin ≥ 8.0 g/dL
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose; men and women must use effective contraception from consent until 5 months after last dose
- Prohibited from donating sperm or ova during the study and 5 months after last dose
You will not qualify if you...
- History of allergic reactions to SCTC21C or its ingredients, or severe drug allergy
- Received antineoplastic drugs (except hormones) or radiotherapy within 4 weeks prior to first dose, or immunotherapy/anti-CD38 antibody within 6 months
- Previous treatment adverse events not resolved to Grade 1 or less
- Prior immunotherapy with Grade 3 or higher cytokine release syndrome
- Central nervous system involvement
- Positive for HIV antibody
- Positive for hepatitis B surface antigen or hepatitis C antibody with high viral load
- Active infections needing systemic treatment within 1 week prior to first dose
- History of other 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 stem cell or solid organ transplantation, or autologous stem cell transplantation 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 deems participant ineligible for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or unacceptable drug-related adverse events
Participants receive SCTC21C injections subcutaneously with a schedule of weekly doses for the first two cycles, every 2 weeks for cycles 3 to 6, and every 4 weeks thereafter until disease progression or unacceptable side effects occur.
Weekly visits for up to 2 cycles, then visits every 2 weeks for cycles 3 to 6, followed by visits every 4 weeks thereafter
Trial Site Locations
Total: 1 location
1
Beijing Chaoyang Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Q
Qiang Zhou
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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