A Clinical Trial of TQB2934 for Injection in Multiple Myeloma Subjects

NCT05646758 | Recruiting Phase 1

• 1 other identifier: TQB2934-I-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 7

Brief Summary

TQB2934 is an anti-CD3(Early T Cell Marker)×BCMA (B cell maturation antigen) double-specific antibody，and the isoform is IgG1 (Native Immunoglobulin G1), which at one end binds to the CD3 receptor on the surface of T cells ,and the other end binds to BCMA(B cell maturation antigen) to recruit T cells around BCMA-positive cells, which can activate T cells .Active T cells release granzyme and perforin to kill BCMA-positive target cells.TQB2934 for injection is planned for the treatment of patients with multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (5)

• Dose-limiting toxicity (DLT)

  DLT refers to any of the toxicity events in the first administration of TQB2934 for injection to the end of the first treatment cycle.

  Up to 18 months

• Maximum Tolerated Dose (MTD)

  After the trial, ordinal regression was used to determine the maximum tolerated dose (MTD)

  Up to 18 months

• Incidence and severity of serious adverse events (AEs)

  Incidence and severity of serios adverse events (AEs) will be reported for safety evaluation.

  Up to 18 months

• Incidence and severity of adverse events (AEs)

  Incidence and severity of adverse events (AEs) will be reported for safety evaluation.

  Up to 18 months

• Incidence and severity abnormal laboratory test value

  Incidence and severity abnormal laboratory test value will be reported for safety evaluation.

  Up to 18 months

Secondary Outcomes (23)

• Elimination half-life (t1/2)

  120 hours after administration

• Area under the plasma concentration-time curve (AUC0-last)

  120 hours after administration

• Apparent clearance (CL)

  120 hours after administration

• Terminal phase apparent volume of distribution (Vz)

  120 hours after administration

• Plasma trough concentration (Cmin)

  120 hours after administration

Study Arms (1)

TQB2934 injection

EXPERIMENTAL

intravenous injection. 0.09mg, 0.36 mg, 1mg, 2mg, 3mg, 5mg, 6mg, 10mg, 12mg, 16mg, 20mg each time. once a week in Cycle 1-3. once every 2 weeks in Cycle 4-6. if reach PR and above remission after 6 cycles of administration, once every 4 weeks,28 days as a treatment cycle.

Drug: TQB2934 injection

Interventions

TQB2934 injection DRUG

TQB2934 is an anti-CD3×BCMA double-specific antibody，which at one end binds to the CD3 receptor on the surface of T cells ,and the other end binds to BCMA to recruit T cells around BCMA-positive cells, which can activate T cells .Active T cells release granzyme and perforin to kill BCMA-positive target cells.

TQB2934 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects volunteered to join the study and signed informed consent form (ICF)with good compliance;
• Age: ≥ 18 years old (when signing ICF); ECOG PS score: 0-1; The expected survival period is more than 3 months;
• Multiple myeloma with diagnostic records and meeting the IMWG diagnostic criteria;
• In the presence of measurable lesions, at least one of the following criteria must be met:
• Serum monoclonal immunoglobulin (M protein)≥1.0g/dL,or urine M protein≥200mg/24h;
• Light chain type: serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL, and the ratio of free light chain serum immunoglobulin κ and λ is abnormal;
• Relapsed or refractory multiple myeloma who have received at least 1 line of therapy in the past, and are refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulator (IMiD) and 1 CD38 monoclonal antibody;
• Disease progression during or within 12 months after the last treatment (meeting the PD criteria of IMWG), including refractory or no remission of the last treatment (≥1 cycle) or disease progression within 6 months;
• Major organ function is good;
• Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7 days before study enrollment;

You may not qualify if:

• Comorbidities and medical history:
• Other malignant tumors have occurred or are currently suffering from other malignant tumors within 3 years before the first medication.
• Unresolved toxic reactions higher than CTC AE grade 1 or higher due to any previous treatment, excluding alopecia, fatigue and peripheral neuropathy;
• Major surgical intervention, open biopsy, or significant traumatic injury within 28 days prior to first dose;
• long-term unhealed wounds or fractures;
• Hyperactive/venous thrombosis events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
• Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
• Subjects with any severe and/or uncontrolled disease,include:
• Unsatisfactory blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, at least 2 measurements at intervals of more than 24 hours);
• Myocardial infarction, unstable angina, CTC AE ≥ grade 2 stable angina, ≥ grade 2 heart failure (New York Heart Association (NYHA) classification), ≥ grade 2 arrhythmia occurred within 6 months before the first medication;
• Cardiac ultrasound evaluation: left ventricular ejection fraction (LVEF) \<50%;
• Active or uncontrolled severe bacterial, viral or systemic fungal infection within 28 days before the first dose (≥CTC AE grade 2 infection);
• Hepatitis (meeting one of the following criteria: hepatitis B: HBV DNA detection value exceeds the upper limit of normal value; hepatitis C: HCV RNA detection value exceeds the upper limit of normal value) or decompensated cirrhosis (Child-Pugh grade B, C grade;
• Chronic obstructive pulmonary disease (COPD) and forced expiratory volume in 1 second (FEV1) \<60% of predicted value.
• Has developed or currently suffered from asthma within 2 years before the first medication;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (7)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Sun Yat-Sen University Cancer Canter

Guangzhou, Guangdong, 510060, China

RECRUITING

The Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Shandong First Medical University Affiliated Tumor Hospital

Jinan, Shandong, 250117, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Peng Liu, Doctor

CONTACT

021-60267405; Liu.peng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 12, 2022
• Study Start: March 17, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)