RecruitingPhase 1NCT06252298
A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies
A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies
Sponsor
Sinocelltech Ltd.
Enrollment
74 participants
Start Date
Feb 28, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- Male or female aged ≥ 18 years old when signing ICF, weight ≥ 40 kg, ≤ 90 kg
- Relapsed or refractory CD38+（confirmed by immunohistochemistry or flow cytometry） hematologic malignancies
- Standard therapies failed or are unavailable or intolerant
- Participants have at least one of the measurable lesions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy ≥3 months
- Participants with basically normal liver, kidney and heart functions
- Hematology requirements: platelet≥75x10\^9 /L,absolute neutrophil counts ≥ 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) or male participants must use a highly effective method of contraception from signed ICF to 5 months after the last dose.All participants are prohibited from donating sperms or ova during the study period and 5 months after the last dose
Exclusion Criteria16
- A history of allergic reactions to any SCTC21C injection or any excipients, or Participants with a history of severe drug allergy
- Participants who have other antineoplastic drug (except hormones) or radiotherapy within four weeks prior to the first dose of study drug, or the participants who have received immunotherapy or anti-CD38 monoclonal antibody within 6 months
- Adverse events from the previous treatment have not resolved to ≤ Grade 1
- Participants with prior immunotherapy and Grade ≥ 3 cytokine release syndrome(CRS)
- Central nervous system involvement
- Participants with positive Human immunodeficiency virus (HIV) antibody
- HBsAg positive with HBV-DNA titer higher than the lower limit of the test value of the research center, or HCV antibody positive with HCV-RNA titer higher than the lower limit of the test value of the research center
- Active infections that require systemic treatment within 1 week prior to the first dose
- History of additional malignant tumor or active autoimmune diseases,or participants with other serious medical conditions
- Participants underwent major surgery within 4 weeks prior to the first dose, or had a surgical schedule during the study period
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation,or history of autologous hematopoietic stem cell transplantation within 6 months prior to screening
- Participants with significant digestive system dysfunction that may affect drug intake, transport and absorption
- Participants who have received live vaccines within 30 days prior to the first dose of study drug
- Participants with mental disorders or poor compliance
- Female participants who are breastfeeding
- The Investigator determined that the participant is ineligible for the study for other reasons
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Interventions
BIOLOGICALSCTC21C
SCTC21C is injected to the participants subcutaneously and is tentatively scheduled to be administered weekly for the first two cycles, once every 2weeks for cycle3-6, and once every 4 weeks thereafter until the occurrence of progressive disease
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06252298