A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies

Relapsed or Refractory Hematologic Malignancies Clinical Trial

Official title:

A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252298
• Other study ID #: SCTC21C-X101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 28, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: January 2024
• Source: Sinocelltech Ltd.
• Contact: Qiang Zhou
• Phone: +86-10-58628288
• Email: qiang_zhou[@]sinocelltech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: February 28, 2027
• Est. primary completion date: August 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Neoplasms
• Relapsed or Refractory Hematologic Malignancies

Intervention

Biological:
• SCTC21C
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

Country	Name	City	State
China	Beijing Chaoyang Hospital ,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE)	To identify the incidence of TEAEs and SAE	From the initiation of the first dose to the 45 days after the last dose
Primary	The incidence of dose limiting toxicities (dose-finding stage)	To identify the DLTs	Cycle 1 (28 days)
Secondary	Objective response rate (ORR)	ORR is defined as the proportion of patients who have an objective remission	Throughout the study treatment,an average of 1 year