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

NCT ID: NCT06252298

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2027-02-28

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.

Conditions

Relapsed or Refractory Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose-finding and dose-expansion

Dose-finding stage: The dose escalation in this study is pre-defined in nine dose groups. The dose escalation starts with 0.01mg and proceeds from low to high doses.

Dose-expansion stage: Patients will be randomly assigned to receive different doses of SCTC21C at a ratio of 1:1. Doses of SCTC21C will be determined based on the data obtained in the Dose-finding stage.

Group Type: EXPERIMENTAL

SCTC21C

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Chaoyang Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Zhou

Role: CONTACT

qiang_zhou@sinocelltech.com

+86-10-58628288

Facility Contacts

Wenming Chen

Role: primary

13910107759@163.com

13910107759

Other Identifiers

SCTC21C-X101

Identifier Type: -

Identifier Source: org_study_id