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New treatment option for Relapsed or Refractory Hematologic Malignancies
Official title A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies
ClinicalTrials.gov ID: NCT06252298
What this study is testing
What is SCTC21C?
SCTC21C is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for relapsed or refractory hematologic malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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
- The Investigator determined that the participant is ineligible for the study for other reasons
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.