Relapsed or Refractory Multiple MyelomaPhase 1NCT04684108
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
A Phase 1 study testing SG301 in people with Relapsed or Refractory Multiple Myeloma and Hematological Malignancy, run by Hangzhou Sumgen Biotech Co., Ltd. at 14 sites in China.
Trial summary
This is a Phase 1a/1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG301 in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma, Hematological Malignancy
- What is being tested?
- SG301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 14 sitesChina
- Study dates
- 4 Nov 2021to 30 Dec 2026
- 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
- Understand and voluntarily sign the informed consent form (ICF).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.
- Expected survival time of ≥3 months.
- Patients with histologically or cytologically confirmed hematological malignancies who are relapsed or refractory to or intolerant of standard therapies.
- For patients with multiple myeloma: should be relapsed or refractory multiple myeloma with measurable disease
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- Adequate organ function
- Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0), except for alopecia, controlled Grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders.
- Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 6 months (180 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test during screening period and must not be lactating.
Who cannot join
- Patient Exclusion Criteria:
- Presence of central nervous system metastatic lesions.
- uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months.
- Active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration.
- Patients with active viral hepatitis (any etiology) are excluded.
- Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer)
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- Primary refractory to previous anti-CD38 therapy.
- Major surgery within 4 weeks prior to study entry.
- Prior or concurrent malignancy within 2 years prior to entry, other than adequately controlled skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma.
- Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, 100020
Beijing Jishuitan Hostipal
Beijing, Beijing Municipality, 100032
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233099
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110136
Shenzhen Second People's Hospital
Shenzhen, Guangzhou, 518025
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Shanxi Norman Bethune Hospital
Taiyuan, Shanxi, 030032
Wuhan University Central South Hospital
Wuhan, Hubei, 430062
Wuxi Central Hospital
Wuxi, Jiangsu, 214125
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official title: A Phase 1 Study of SG301 in Subjects With Hematological Malignancies
This is a Phase 1a/1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG301 in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Read the detailed description
After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG301, administered weekly for the first 2 cycles and every 2 weeks thereafter, until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first.
The study consists of a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b) in subjects with relapsed or refractory multiple myeloma and other hematological malignancies.
- Being tested
- SG301
- Medical subject headings
- Recurrence, Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG301Drug
Phase 1a will use an accelerated titration and 3+3 design with 9 dose cohorts: 0.005 mg/kg, 0.05 mg/kg,0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, 12 mg/kg and 16 mg/kg by IV infusion. Accelerated titration (i.e., 1 patient each) will be applied to the first 3 cohorts.
| Study group | Role | What they receive |
|---|---|---|
| SG301 | Experimental | SG301 monotherapy intravenous (IV) infusion Receives: Drug: SG301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0
Measured: Through study completion, an average of one year
MTD/MAD/ RP2D
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG301 in patients with relapsed or refractory multiple myeloma and other hematological malignancies; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG301 given intravenously in patients with relapsed or refractory multiple myeloma and other hematological malignancies.
Measured: Through study completion, an average of one year
Secondary outcomes (6)
Pharmacokinetics (PK): AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Measured: Through study completion, an average of one year
Pharmacokinetics (PK): Cmax
Maximum concentration(Cmax) of the drug after administration
Measured: Through study completion, an average of one year
Pharmacokinetics (PK): limination half-life (T 1/2)
Descripition: limination half-life (T 1/2) of the drug after administration
Measured: Through study completion, an average of one year
receptor occupancy (RO)
receptor occupancy (RO) of CD38 on the surface of peripheral blood cells
Measured: Through study completion, an average of one year
Immunogenicity endpoints
levels of anti-drug antibodies (ADAs) and neutralizing antibodies (tested in ADA-positive samples only).
Measured: Through study completion, an average of one year
Efficacy endpoints
objective response rate (ORR)
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start4 Nov 2021
- Primary completion30 Jun 2024
- Study completion30 Dec 2026 (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 Multiple MyelomaStudies of the same condition, open and under way.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684108
- Sponsor's protocol ID
- CSG-301-101
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2020
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SG301 in Subjects With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04684108
- Acronym / sponsor ID
- CSG-301-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Dec 2020 (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.
This is a Phase 1a/1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG301 in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Detailed description
After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG301, administered weekly for the first 2 cycles and every 2 weeks thereafter, until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first.
The study consists of a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b) in subjects with relapsed or refractory multiple myeloma and other hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG301 | Experimental | Drug: SG301SG301 monotherapy intravenous (IV) infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Understand and voluntarily sign the informed consent form (ICF).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.
- Expected survival time of ≥3 months.
- Patients with histologically or cytologically confirmed hematological malignancies who are relapsed or refractory to or intolerant of standard therapies.
Key exclusion criteria (10 listed)
- Presence of central nervous system metastatic lesions.
- uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months.
- Active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration.
- Patients with active viral hepatitis (any etiology) are excluded.
- Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer)
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 |
|---|---|---|
| SG301Phase 1a will use an accelerated titration and 3+3 design with 9 dose cohorts: 0.005 mg/kg, 0.05 mg/kg,0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, 12 mg/kg and 16 mg/kg by IV infusion. Accelerated titration (i.e., 1 patient each) will be applied to the first 3 cohorts. | Drug | SG301 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of one year
Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0
MTD/MAD/ RP2D
Time frame: Through study completion, an average of one year
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG301 in patients with relapsed or refractory multiple myeloma and other hematological malignancies; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG301 given intravenously in patients with relapsed or refractory multiple myeloma and other hematological malignancies.
6 secondary outcomes
Pharmacokinetics (PK): AUC
Time frame: Through study completion, an average of one year
Pharmacokinetics (PK): Cmax
Time frame: Through study completion, an average of one year
Pharmacokinetics (PK): limination half-life (T 1/2)
Time frame: Through study completion, an average of one year
receptor occupancy (RO)
Time frame: Through study completion, an average of one year
Immunogenicity endpoints
Time frame: Through study completion, an average of one year
Efficacy endpoints
Time frame: Through study completion, an average of one 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 11 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SG301 in people with Relapsed or Refractory Multiple Myeloma and Hematological Malignancy, run by Hangzhou Sumgen Biotech Co., Ltd. at 14 sites 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 10 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Through study completion, an average of one year). 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 11 Aug 2026.