Relapsed or Refractory Hematologic Malignancies
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies
Detailed description
This is a multicenter, open-label, phase I study aimed to evaluate the safety, tolerability, pharmacokinetics（PK）, Pharmacodynamics（PD）, preliminary anti-tumor activity and immunogenicity of SCTC21C in patients with relapsed or refractory CD38+ hematologic malignancies.The study includes Dose-finding stage and Dose-expansion stage. In Dose-finding stage, participants will be assigned to receive sequentially higher doses of SCTC21C ranging from 0.01 to 960mg. In Dose-expansion stage, total of at least 20 participants will be randomly assigned to receive two different doses of SCTC21C at a ratio of 1:1.All participants will receive the treatment until disease progression or unacceptable drug-related adverse events.
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
Sponsors
Sinocelltech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged ≥ 18 years old when signing ICF, weight ≥ 40 kg, ≤ 90 kg 2. Relapsed or refractory CD38+（confirmed by immunohistochemistry or flow cytometry） hematologic malignancies 3. Standard therapies failed or are unavailable or intolerant 4. Participants have at least one of the measurable lesions 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 6. Life expectancy ≥3 months 7. Participants with basically normal liver, kidney and heart functions 8. Hematology requirements: platelet≥75x10\^9 /L,absolute neutrophil counts ≥ 1.0x10\^9 /L, hemoglobin ≥ 8.0 g/dL 9. 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 criteria
1. A history of allergic reactions to any SCTC21C injection or any excipients, or Participants with a history of severe drug allergy 2. 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 3. Adverse events from the previous treatment have not resolved to ≤ Grade 1 4. Participants with prior immunotherapy and Grade ≥ 3 cytokine release syndrome(CRS) 5. Central nervous system involvement 6. Participants with positive Human immunodeficiency virus (HIV) antibody 7. 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 8. Active infections that require systemic treatment within 1 week prior to the first dose 9. History of additional malignant tumor or active autoimmune diseases,or participants with other serious medical conditions 10. Participants underwent major surgery within 4 weeks prior to the first dose, or had a surgical schedule during the study period 11. 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 12. Participants with significant digestive system dysfunction that may affect drug intake, transport and absorption 13. Participants who have received live vaccines within 30 days prior to the first dose of study drug 14. Participants with mental disorders or poor compliance 15. Female participants who are breastfeeding 16. The Investigator determined that the participant is ineligible for the study for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE) | From the initiation of the first dose to the 45 days after the last dose | To identify the incidence of TEAEs and SAE |
| The incidence of dose limiting toxicities （dose-finding stage） | Cycle 1 (28 days) | To identify the DLTs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Throughout the study treatment,an average of 1 year | ORR is defined as the proportion of patients who have an objective remission |
Countries
China
Contacts
Primary ContactQiang Zhou
Outcome results
None listed