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

NCT06252298 | Recruiting Phase 1

• 1 other identifier: SCTC21C-X101
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed or Refractory Hematologic Malignancies

Outcome Measures

Primary Outcomes (2)

• 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

• The incidence of dose limiting toxicities （dose-finding stage）

  To identify the DLTs

  Cycle 1 (28 days)

Secondary Outcomes (1)

• Objective response rate (ORR)

  Throughout the study treatment,an average of 1 year

Study Arms (1)

Dose-finding and dose-expansion

EXPERIMENTAL

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.

Biological: SCTC21C

Interventions

SCTC21C 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

Dose-finding and dose-expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Beijing Chaoyang Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Qiang Zhou

CONTACT

+86-10-58628288; qiang_zhou@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 9, 2024
• Study Start: February 28, 2024
• Primary Completion: August 28, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 22, 2024

Record last verified: 2024-01

Locations

CN (1)