Relapsed or Refractory Hematologic MalignanciesPhase 1NCT06252298
A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies
A Phase 1 study testing SCTC21C in people with Relapsed or Refractory Hematologic Malignancies, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Hematologic Malignancies
- What is being tested?
- SCTC21C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital ,Capital Medical University
Beijing, Beijing Municipality
Wenming Chen, 13910107759, 13910107759@163.com
About this study
Official title: A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies
The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies
Read the 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.
- Being tested
- SCTC21C
- Medical subject headings
- Recurrence, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTC21CBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: SCTC21C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE)
To identify the incidence of TEAEs and SAE
Measured: 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
Measured: Cycle 1 (28 days)
Secondary outcomes (1)
Objective response rate (ORR)
ORR is defined as the proportion of patients who have an objective remission
Measured: Throughout the study treatment,an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start28 Feb 2024
- Primary completion28 Aug 2025 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252298
- Sponsor's protocol ID
- SCTC21C-X101
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT06252298
- Acronym / sponsor ID
- SCTC21C-X101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-finding and dose-expansion | Experimental | Biological: SCTC21CDose-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTC21CSCTC21C 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 | Biological | Dose-finding and dose-expansion |
Primary outcome
Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE)
Time frame: From the initiation of the first dose to the 45 days after the last dose
To identify the incidence of TEAEs and SAE
The incidence of dose limiting toxicities （dose-finding stage）
Time frame: Cycle 1 (28 days)
To identify the DLTs
1 secondary outcome
Objective response rate (ORR)
Time frame: Throughout the study treatment,an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCTC21C in people with Relapsed or Refractory Hematologic Malignancies, run by Sinocelltech Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Zhou (+86-10-58628288, qiang_zhou@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE) (time frame: From the initiation of the first dose to the 45 days after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.