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New drug SG301 tested in blood cancer patients who have run out of options

NCT ID NCT04684108

Disease control Sponsor: Hangzhou Sumgen Biotech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called SG301 in about 61 people with blood cancers like multiple myeloma that have returned or not responded to standard treatments. The main goal is to check the drug's safety and find the best dose to use in future studies. Researchers will also look at how the drug moves through the body and whether it shows any signs of fighting the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SG301 (a drug given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with blood cancers that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 61 participants, focused mainly on safety and dosing. It is too soon to know if SG301 will be effective, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

61 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form (ICF). 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2. 4. Expected survival time of ≥3 months. 5. 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 6. Adequate organ function 7. 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. 8. 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. Exclusion Criteria: Patient Exclusion Criteria: 1. Presence of central nervous system metastatic lesions. 2. 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. 3. Active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration. 4. Patients with active viral hepatitis (any etiology) are excluded. 5. Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer) 6. Primary refractory to previous anti-CD38 therapy. 7. Major surgery within 4 weeks prior to study entry. 8. 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. 9. Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm plasma cell myeloma Recurrence refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematological malignancy Relapsed or refractory multiple myeloma

Contacts and locations

Locations

  • Affiliated Beijing Chaoyang Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100020, China

  • Beijing Jishuitan Hostipal

    Beijing, Beijing Municipality, 100032, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250063, China

  • Shanxi Norman Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110136, China

  • Shenzhen Second People's Hospital

    Shenzhen, Guangzhou, 518025, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099, China

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110002, China

  • The Fourth Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • Wuhan University Central South Hospital

    Wuhan, Hubei, 430062, China

  • Wuxi Central Hospital

    Wuxi, Jiangsu, 214125, China

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021, China

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