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Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

2026. május 7. frissítette: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2934 Injection Versus Investigator-Selected Regimens in Patients With Relapsed/Refractory Multiple Myeloma

This study is a randomized, open-label, multicenter Phase III clinical trial involving patients with relapsed/refractory multiple myeloma. The estimated total sample size is 260 cases, who will be randomly assigned in a 1:1 ratio to the test group and the control group. The primary objective of the study is to demonstrate the efficacy of TQB2934 for injection compared to the investigator-selected regimen in subjects with relapsed or refractory multiple myeloma (RRMM) by evaluating progression-free survival (PFS).

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

260

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Kína
    • Anhui
      • Bengbu, Anhui, Kína, 233004
        • The First Affiliated Hospital of Bengbu Medical University
        • Kapcsolatba lépni:
      • Hefei, Anhui, Kína, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Kapcsolatba lépni:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kína, 100020
        • Beijing Chao-Yang Hospital,Capital Medical University
      • Beijing, Beijing Municipality, Kína, 100020
        • Beijing Jishuitan Hospital,Capital Medical University
        • Kapcsolatba lépni:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kína, 400010
        • The First Affiliated Hospital of Chongqing Medical University
        • Kapcsolatba lépni:
      • Chongqing, Chongqing Municipality, Kína, 400038
        • The Southwest Hospital of Amu
        • Kapcsolatba lépni:
    • Gansu
      • Lanzhou, Gansu, Kína, 730030
        • Lanzhou University Second Hospital
        • Kapcsolatba lépni:
      • Lanzhou, Gansu, Kína, 730000
        • Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital)
        • Kapcsolatba lépni:
    • Guangdong
      • Guangzhou, Guangdong, Kína, 510280
        • ZhuJiang Hospital of Southern Medical University
        • Kapcsolatba lépni:
      • Guangzhou, Guangdong, Kína, 510000
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Kapcsolatba lépni:
      • Guangzhou, Guangdong, Kína, 510062
        • Sun Yat-sen University Cancer Center
        • Kapcsolatba lépni:
      • Zhanjiang, Guangdong, Kína, 524023
        • Affiliated Hospital of Guangdong Medical University
        • Kapcsolatba lépni:
          • Honghua He, Master
          • Telefonszám: 13828229695
          • E-mail: 192880@qq.com
    • Guangxi
      • Nanning, Guangxi, Kína, 530000
        • The First Affiliated Hospital of Guangxi Medical University
        • Kapcsolatba lépni:
    • Guizhou
      • Guiyang, Guizhou, Kína, 550001
        • The Affiliated Hospital of Guizhou Medical University
        • Kapcsolatba lépni:
    • Hebei
      • Cangzhou, Hebei, Kína, 061000
        • Cangzhou People's Hospital
        • Kapcsolatba lépni:
      • Chengde, Hebei, Kína, 067000
        • Affiliated Hospital of Chengde Medical University
        • Kapcsolatba lépni:
      • Shijiazhuang, Hebei, Kína, 050000
        • The Second Hospital of Hebeimedical University
        • Kapcsolatba lépni:
    • Heilongjiang
      • Harbin, Heilongjiang, Kína, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Kapcsolatba lépni:
    • Henan
      • Luoyang, Henan, Kína, 471000
        • Luoyang Central Hospital
        • Kapcsolatba lépni:
      • Zhengzhou, Henan, Kína, 450000
        • Henan Cancer Hospital
        • Kapcsolatba lépni:
      • Zhengzhou, Henan, Kína, 450000
        • Henan Provincial People's Hospital
        • Kapcsolatba lépni:
      • Zhengzhou, Henan, Kína, 451191
        • The First Affiliated Hospital of Zhengzhou University
        • Kapcsolatba lépni:
    • Hunan
      • Changsha, Hunan, Kína, 410013
        • The Third XIANGYA Hospital of Central South University
        • Kapcsolatba lépni:
      • Zhuzhou, Hunan, Kína, 412007
        • Zhuzhou Central Hospital
        • Kapcsolatba lépni:
    • Jiangsu
      • Nanjing, Jiangsu, Kína, 210029
        • Jiangsu Province Hospital
        • Kapcsolatba lépni:
      • Nanjing, Jiangsu, Kína, 210009
        • Zhongda Hospital Southeast University
        • Kapcsolatba lépni:
      • Xuzhou, Jiangsu, Kína, 221004
        • The Affiliated Hospital of Xuzhou Medical University
        • Kapcsolatba lépni:
    • Jiangxi
      • Nanchang, Jiangxi, Kína, 330006
        • The Second Affiliated Hospital of Nanchang University
        • Kapcsolatba lépni:
      • Nanchang, Jiangxi, Kína, 330038
        • Jiangxi Provincial People's Hospital
        • Kapcsolatba lépni:
    • Liaoning
      • Shenyang, Liaoning, Kína, 110000
        • Shengjing Hospital of China Medical University
        • Kapcsolatba lépni:
    • Shaanxi
      • Xi'an, Shaanxi, Kína, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Kapcsolatba lépni:
      • Xi'an, Shaanxi, Kína, 710048
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Kapcsolatba lépni:
    • Shandong
      • Binzhou, Shandong, Kína, 256600
        • Binzhou Medical University Hospital
        • Kapcsolatba lépni:
      • Jinan, Shandong, Kína, 250117
        • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
        • Kapcsolatba lépni:
      • Jinan, Shandong, Kína, 250021
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）
        • Kapcsolatba lépni:
      • Jining, Shandong, Kína, 272111
        • Jining No.1 People's Hospital
        • Kapcsolatba lépni:
      • Qingdao, Shandong, Kína, 266011
        • Qingdao Municipal Hospital
        • Kapcsolatba lépni:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kína, 200032
        • Zhongshan Hospital Fudan University
        • Kapcsolatba lépni:
      • Shanghai, Shanghai Municipality, Kína, 200233
    • Shanxi
      • Changzhi, Shanxi, Kína, 46000
        • Heping Hospital Affiliated to Changzhi Medical College
        • Kapcsolatba lépni:
      • Taiyuan, Shanxi, Kína, 30000
        • Shanxi Provincial Cancer Hospital
        • Kapcsolatba lépni:
    • Sichuan
      • Chengdu, Sichuan, Kína, 610072
        • Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
        • Kapcsolatba lépni:
      • Luzhou, Sichuan, Kína, 646000
        • The Affiliated Hospital of Southwest Medical University
        • Kapcsolatba lépni:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kína, 300121
        • Tianjin Union Medical Center
    • Xinjiang
      • Ürümqi, Xinjiang, Kína, 830000
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Kapcsolatba lépni:
    • Yunnan
      • Kunming, Yunnan, Kína, 650000
        • The First Affiliated Hospital of Kunming Medical University
        • Kapcsolatba lépni:
    • Zhejiang
      • Hangzhou, Zhejiang, Kína, 310000
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Ningbo, Zhejiang, Kína, 315000
        • The First Affiliated Hospital of Ningbo Universty
        • Kapcsolatba lépni:
      • Ningbo, Zhejiang, Kína, 315016
        • Ningbo No.2 Hospitai
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: TQB2934 injection
TQB2934 injection, 28 days as a treatment cycle.
Drog: TQB2934 injection
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Aktív összehasonlító: Selinexor and Dexamethasone or Pomalidomide Dexamethasone
Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
Drog: Pomalidomide Capsule
Pomalidomide capsules are an immunomodulatory(IMiD).
Drog: Selinexor tablets
Selinexor is a selective nuclear export protein inhibitor.
Drog: Dexamethasone tablets
Dexamethasone tablets are a type of adrenocortical hormone drug.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Progression-free survival (PFS)
Időkeret: Baseline up to 5 years
The time from randomization to disease progression or death from any cause, whichever occurs first.
Baseline up to 5 years

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Investigator-assessed PFS
Időkeret: Baseline up to 5 years
The time from randomization to disease progression or death from any cause, whichever comes first.
Baseline up to 5 years
PFS rates at 6, 12 and 18 months
Időkeret: From baseline to 18 months
The proportion of patients who remain free from disease progression or death at 6, 12 and 18 months after randomization.
From baseline to 18 months
Overall response rate (ORR)
Időkeret: Baseline up to 5 years
The proportion of patients with a complete response (CR) or partial response (PR) after treatment.
Baseline up to 5 years
Very Good Partial Response (VGPR)
Időkeret: Baseline up to 5 years
The best overall response is defined as the sum proportion of subjects achieving stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). or very good partial response (VGPR).
Baseline up to 5 years
Complete Response (CR) Rate
Időkeret: Baseline up to 5 years
The percentage of evaluable subjects who achieve complete response (CR).
Baseline up to 5 years
Duration of remission (DOR)
Időkeret: Baseline up to 5 years
The time from the first onset of objective response to the first documentation of disease progression or death from any cause, whichever occurs first.
Baseline up to 5 years
Time to first remission (TTR)
Időkeret: Baseline up to 5 years
The time from randomization to the first achievement of objective response.
Baseline up to 5 years
Negative rate of minimal residual disease (MRD)
Időkeret: Baseline up to 5 years
The proportion of subjects achieving MRD negativity.
Baseline up to 5 years
Overall survival (OS)
Időkeret: From randomization to death, the estimated evaluation period is up to 5 years
Time from randomization to death.
From randomization to death, the estimated evaluation period is up to 5 years
Adverse event rate
Időkeret: From randomization to 2 months after the last dose
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
From randomization to 2 months after the last dose
Peak concentration (Cmax)
Időkeret: Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, after dose of Cycle 2 Day 1, Cycle 6 Day 1，Last visit (up to 5 years), each cycle is 28 days.
Maximum plasma drug concentration.
Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, after dose of Cycle 2 Day 1, Cycle 6 Day 1，Last visit (up to 5 years), each cycle is 28 days.
Anti-drug antibody (ADA) positive rate
Időkeret: Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.
The proportion of evaluable subjects with positive test results for anti-drug antibody (ADA).
Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.
Nab positive rate
Időkeret: Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.
The percentage of evaluable subjects with positive neutralizing antibody (NAB) test results in all evaluable subjects.
Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. június 1.

Elsődleges befejezés (Becsült)

2028. december 1.

A tanulmány befejezése (Becsült)

2030. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 29.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. április 29.

Első közzététel (Tényleges)

2026. május 6.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. május 8.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 7.

Utolsó ellenőrzés

2026. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • TQB2934-III-01

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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