New hope for Tough-to-Treat myeloma: phase 3 trial launches

NCT ID NCT07569757

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called TQB2934 in 260 people whose multiple myeloma has returned or stopped responding to treatment. Participants are randomly assigned to receive either TQB2934 or one of several standard treatments chosen by their doctor. The main goal is to see if TQB2934 can delay the cancer from getting worse.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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 to 75 years

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: * Voluntarily join this study, sign the Informed Consent Form (ICF), and demonstrate good compliance. * Aged 18 to 75 years old (as of the date of signing the ICF); gender not limited; Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2. * Expected survival greater than 3 months. * Patients with relapsed or refractory multiple myeloma. * During or after the most recent treatment, there is evidence of disease progression or failure to achieve remission after the last line of treatment。 * Measurable disease at screening. * Adequate organ function as indicated by laboratory tests meeting the criteria. * Women of childbearing potential must agree to use effective contraception during the study and for 12 months after the last dose of study treatment, and agree not to donate eggs for reproduction during this period. Must not be breastfeeding and must have a negative serum or urine pregnancy test within 7 days prior to enrollment. Men who have not had a vasectomy and their female partners of childbearing potential should also agree to use effective contraception during the study and for 12 months after the last dose of study treatment, and agree not to donate sperm during this period. Exclusion Criteria: * History of other malignancies within 5 years prior to informed consent or concurrent presence of other malignancies. The following exceptions are allowed: other malignancies cured by surgery alone with a disease-free survival (DFS) ≥5 years; cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\]. * Diagnosis of plasma cell leukemia (defined as circulating plasma cells ≥5% in peripheral blood according to standard classification), Waldenström macroglobulinemia, primary light-chain (AL) amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M protein\], and skin changes), or solitary plasmacytoma. * History of prior anticancer treatment, including but not limited to: 1. Receipt of chimeric antigen receptor T-cell (CAR-T), Chimeric Antigen Receptor T-Cell Immunotherapy(CAR-T), Chimeric Antigen Receptor Natural Killer Cells (CAR-NK), or other cellular therapies within 3 months prior to randomization; 2. Receipt of autologous stem cell transplantation within 3 months prior to randomization; 3. Receipt of allogeneic stem cell transplantation within 6 months prior to randomization; subjects must have discontinued all immunosuppressive therapy for ≥6 weeks and have no signs or symptoms of graft-versus-host disease (GVHD); 4. Receipt of molecular targeted therapy, investigational drugs, or invasive investigational medical devices within 3 weeks or 5 drug half-lives (whichever is shorter) prior to randomization; 5. Receipt of monoclonal antibodies, bispecific antibodies, chemotherapy, etc., within 3 weeks prior to randomization; 6. Receipt of proteasome inhibitors (PI), immunomodulatory drugs (IMiDs), localized radiotherapy, palliative radiotherapy, or Chinese patent medicines with antitumor indications approved by the National Medical Products Administration (NMPA) within 2 weeks prior to randomization. * Previously refractory to control group drugs, or with contraindications, life-threatening allergic reactions, or intolerance to previous treatments. * Receipt of systemic corticosteroids at a cumulative dose ≥140 mg prednisone (or equivalent) within 2 weeks prior to randomization. Topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are excluded from the cumulative dose calculation (see Appendix for dose conversion). * Toxicities from prior antitumor therapy have not recovered to baseline or ≤ Grade 1, except for Grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized by hormone replacement therapy, as judged by the investigator to pose no safety risk. * History of Grade ≥3 cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting therapies or CAR-T cell therapy). * Presence of conditions affecting intravenous infusion or blood collection, dysphagia, chronic diarrhea, intestinal obstruction, or other active gastrointestinal dysfunction that may interfere with drug administration or absorption. * Known central nervous system (CNS) involvement of multiple myeloma (MM), or clinical signs/symptoms suggestive of leptomeningeal involvement. If either is suspected, both brain MRI and lumbar puncture cytology must be negative. * Major surgery, significant traumatic injury, or planned major surgery during the study treatment period within 4 weeks prior to randomization, or presence of non-healed wounds or fractures (major surgery defined as Grade ≥3 according to the 2022 national surgical classification catalogue). * Any severe (≥ CTCAE Grade 3) bleeding or hemorrhagic event within 6 months prior to randomization. * Arterial or venous thrombotic events within 6 months prior to randomization, including cerebrovascular events (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (implantable venous port- or catheter-related thrombosis and superficial thrombosis are not considered "serious"). * Active hepatitis or decompensated cirrhosis (Child-Pugh Class B or C) * Significant cardiovascular disease. * Neurological or psychiatric disorders. * Pulmonary diseases, including any of the following: 1. Current or prior non-infectious pneumonitis requiring corticosteroid treatment (including but not limited to acute respiratory distress syndrome, acute hypersensitivity pneumonitis, drug-related pneumonitis, bronchospasm, acute interstitial pneumonitis, idiopathic pulmonary fibrosis, etc.); 2. Known or suspected chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) \<60% of predicted. * Active or uncontrolled infections (≥ CTCAE Grade 2), including bacterial, fungal, or viral infections, such as active pneumonia/pulmonary infection, syphilis, tuberculosis, or Corona Virus Disease 2019 (COVID-19). Subjects with positive Cytomegalovirus (CMV) DNA or Epstein-Barr virus (EBV) plasma DNA during screening are not eligible. * Current or prior autoimmune diseases requiring systemic treatment. Subjects with hypothyroidism on stable replacement therapy, well-controlled type 1 diabetes, or skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis) are eligible. * History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disorders. * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH). * Known history of hypersensitivity to humanized monoclonal antibodies, or known allergy, hypersensitivity, or intolerance to any component of the investigational product. * Any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that, in the investigator's opinion, may increase the risk associated with study participation or interfere with interpretation of study results. * Investigator considers that the subject is likely to have poor compliance with study participation.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

How to take part

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

The places running it

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

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, 067000, China
Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524023, China
Beijing Chao-Yang Hospital,Capital Medical University

Beijing, Beijing Municipality, 100020, China
Beijing Jishuitan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100020, China
Binzhou Medical University Hospital

Binzhou, Shandong, 256600, China
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

Jinan, Shandong, 250117, China
Cangzhou People'S Hospital

Cangzhou, Hebei, 061000, China
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital)

Lanzhou, Gansu, 730000, China
Henan Cancer Hospital

Zhengzhou, Henan, 450000, China
Henan Provincial People'S Hospital

Zhengzhou, Henan, 450000, China
Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, 46000, China
Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China
Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330038, China
Jining No.1 People'S Hospital

Jining, Shandong, 272111, China
Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China
Luoyang Central Hospital

Luoyang, Henan, 471000, China
Ningbo No.2 Hospitai

Ningbo, Zhejiang, 315016, China
People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830000, China
Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）

Jinan, Shandong, 250021, China
Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China
Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 30000, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China
Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510062, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China
The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China
The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China
The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, Henan, 451191, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530000, China
The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China
The First Affiliated Hospital of Ningbo Universty

Ningbo, Zhejiang, 315000, China
The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710048, China
The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China
The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China
The Second Hospital of Hebeimedical University

Shijiazhuang, Hebei, 050000, China
The Southwest Hospital of Amu

Chongqing, Chongqing Municipality, 400038, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China
Tianjin Union Medical Center

Tianjin, Tianjin Municipality, 300121, China
ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China
Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China
Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China
Zhuzhou Central Hospital

Zhuzhou, Hunan, 412007, China

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