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New hope for hard-to-treat myeloma: experimental drug LBL-034 enters human trials

NCT ID NCT06049290

Disease control Sponsor: Nanjing Leads Biolabs Co.,Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests an experimental drug called LBL-034 in people whose multiple myeloma has returned or no longer responds to standard treatments. The trial has two phases: first, finding the safest dose, and then checking how well the drug shrinks tumors. About 342 adults will take part across multiple centers.

Why investors are watching

Nanjing Leads Biolabs is testing LBL-034 in patients with relapsed or refractory multiple myeloma, a cancer that has stopped responding to prior treatments. This phase I/II study will show whether the drug is safe and shrinks tumors, and for a small company, this readout is a key test of its lead pipeline asset.

If it works: If LBL-034 shows strong safety and tumor response, Nanjing Leads Biolabs could advance the drug toward later-stage trials and potentially attract partnership interest. A positive result would validate the company's research platform and support its value as a drug developer.

If it fails: The trial could fail to show enough benefit or cause unacceptable side effects, which would set the program back and hurt the company's prospects. Many cancer drugs fail in early trials, so a negative or delayed result is a real risk for a small firm with few other assets.

AI-written from the trial record. Speculative, and not investment advice.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 342 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

May 2027

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. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form; 2. Age ≥ 18 years at the time of signing the informed consent; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale≤ 1； 4. Documentation of initial diagnosis of multiple myeloma according to IMWG diagnostic criteria,or according to the IMWG 2021 diagnostic criteria, the proportion of circulating plasma cells in peripheral blood is ≥ 5%,have documentation to diagnose PCL； 5. Have a life expectancy of at least 12 weeks； 6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug. Exclusion Criteria: 1. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug,or require elective surgery during the trial period; 2. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin-2, and interferon； 3. Systemic use of corticosteroids or other immunosuppressants within 14 days prior to the initial use of the investigational drug;The following conditions are excluded: Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., to prevent contrast allergy); 4. Patients with active hepatitis B or C； 5. Subjects with an active infection that currently requires anti infective therapy; 6. The patient has a Medical history of immunodeficiency, including HIV antibody positive; 7. Women during pregnancy or lactation; 8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

Relapsed/refractory multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, 266011, China

  • Shanghai Fourth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, 030000, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shengyang, Liaoning, 117004, China

  • Shenzhen Second People's Hospital

    RECRUITING

    Shenzhen, Guangdong, 518035, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 516000, China

  • The Afliliated Hospital of Guizhou Medical Univeristy

    RECRUITING

    Guiyang, Guizhou, 563000, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • The First Affiliated Hospital of Henan University

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315000, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Wannan Medical College

    RECRUITING

    Wuhu, Anhui, 241001, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361000, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Bethune Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130000, China

  • The Second Affiliated Hospital of Hainan Medical University

    RECRUITING

    Haikou, Hainan, 570000, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

    RECRUITING

    Xi’an, Shanxi, 710004, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.