Evaluating SCTC21C for patients with CD38+ blood cancers
A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies
This study is testing a new treatment called SCTC21C to see if it can help people with certain types of blood cancers that have come back or didn’t respond to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sinocelltech Ltd. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06252298 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, phase I study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SCTC21C in patients with relapsed or refractory CD38+ hematologic malignancies. The study consists of a dose-finding stage where participants will receive escalating doses of SCTC21C, followed by a dose-expansion stage involving random assignment to two different doses. Participants will continue treatment until disease progression or unacceptable adverse events occur.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory CD38+ hematologic malignancies who have failed standard therapies.
Not a fit: Patients with hematologic malignancies that do not express CD38 or those who are not relapsed or refractory may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.
How similar studies have performed: While this approach is novel, similar studies targeting CD38 in hematologic malignancies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Beijing Chaoyang Hospital ,Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qiang Zhou
- Email: qiang_zhou@sinocelltech.com
- Phone: +86-10-58628288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.