A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors

NCT07179679 | Recruiting Phase 1

• 1 other identifier: TQB2934-I-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 14

Brief Summary

TQB2934 is an anti-Cluster of Differentiation 3 (CD3) (Early T Cell Marker)×B cell maturation antigen (BCMA) 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 (subcutaneous injection) is intended for the treatment of patients with multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (6)

• Peak time (Tmax)

  It refers to the time when TQB2934 (subcutaneous injection) is administered for injection to reach the maximum blood drug concentration.

  Within 120 hours after administration

• Peak drug concentration (Cmax)

  It refers to the highest blood drug concentration after administration of TQB2934 (subcutaneous injection).

  Within 120 hours after administration

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

  To characterize the pharmacokinetics of TQB2934 by assessment of area under the plasma concentration time curve.

  Within 120 hours after administration

• Elimination half-life (t1/2)

  t1/2 is time it takes for the blood concentration of TQB2934 to drop by half.

  Within 120 hours after administration

• Apparent clearance (CL)

  Apparent clearance (CL)

  Within 120 hours after administration

• Adverse events(AEs)

  Incidence and severity of subjects with adverse events(AEs), Abnormal laboratory test value and serious adverse events

  Up to 24 months

Secondary Outcomes (11)

• Overall response rate (ORR)

  Up to 24 months

• Clinical benefit rate (CBR)

  Up to 24 months

• very good partial response rate (VGPR)

  Up to 24 months

• Complete Response (CR) Rate

  Up to 24 months

• Strict Complete Response (sCR)

  Up to 24 months

Study Arms (1)

TQB2934 injection (subcutaneous injection)

EXPERIMENTAL

Subcutaneous injection，40mg.60mg each time,Cycle 1-3, once a week，Cycle 4-6, once every 2 weeks, if reach PR and above remission after 6 cycles of administration, once every 4 weeks,28 days as a treatment cycle.

Drug: TQB2934 injection (subcutaneous injection)

Interventions

TQB2934 injection (subcutaneous injection) DRUG

TQB2934 is an anti-CD3(Early T Cell Marker)×BCMA (B cell maturation antigen)double-specific antibody，and the isoform is Native Immunoglobulin G1 ( IgG1), 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 injection (subcutaneous 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 voluntarily joined the study, signed an informed consent form, and had good compliance;
• years old≤age≤75 years old (calculated based on the date of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG) score 0\~2 points; expected survival is greater than 12 weeks;
• Subjects with multiple myeloma must meet: 1) have a diagnostic record and meet the International Myeloma Working Group Relapsed (IMWG) diagnostic criteria; 2) there is a measurable lesion; 3) Refractory Multiple Myeloma (RRMM) has received at least one line of treatment, and at least one proteasome inhibitor (PI), an immunomodulator (IMiD) and a Cluster of Differentiation 38 (CD38) monoclonal antibody are refractory; 4) disease progression within 12 months after the last treatment or treatment;
• Laboratory inspection standards that meet the program requirements;
• Women of childbearing age should agree that effective contraception must be adopted during the study period and within 6 months after the end of the study, and that serum or urine pregnancy tests will be negative within 7 days before the study enrollment; men should agree that effective contraception must be adopted within 6 months after the end of the study period;

You may not qualify if:

• Diagnosed with amyloidosis, active plasma cell leukemia (PCL, peripheral plasma cell proportion ≥5%, or absolute peripheral plasma cell count ≥0.5×109/L), Fahrenheit macroglobulinemia (WM) or POEMS syndrome and other plasma cell tumors;
• Have received allogeneic hematopoietic stem cell transplantation within 1 year before the first medication, or have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks before the first medication;
• Those who are known to have invasion of meninges or central nervous system or are highly suspected of invasion of meninges or central nervous system but cannot be identified;
• Have received CD3×BCMA dual anti-anti-treatment in the past;
• Cumulative treatment of dexamethasone \>160 mg or equivalent dose of other glucocorticoids within 4 weeks before the first medication, or received targeted therapy, cytotoxic drugs or any antibody therapy within 3 weeks before the first medication, or received proteasome inhibitor therapy or radiotherapy within 2 weeks before the first medication, or received immunomodulatory therapy within 1 week before the first medication;
• Those who have received Chinese patent medicine treatments within 2 weeks before the first medication have received National Medical Products Administration (NMPA) -approved drug instructions that clearly have anti-tumor indications;
• Those who have a history of live attenuated vaccination within 4 weeks before the first medication or plan to undergo live attenuated vaccination during the study period;
• A person with a history of severe allergies of unknown causes, or known to be allergic to monoclonal antibody drugs or exogenous human immunoglobulin, or known to be allergic to TQB2934 for injection or excipients in drug preparations;
• Have appeared within 3 years before the first medication or are currently suffering from other malignant tumors;
• Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE level 1 caused by any previous treatment, excluding hair loss, fatigue and peripheral neuropathy;
• Those who have received major surgical treatment, obvious traumatic injury or expected research treatment within 4 weeks before the first medication, or have long-term uncured wounds or fractures;
• Arterial/venous thrombosis events occurred within 6 months before the first dose;
• People with a history of abuse of psychotropic substances and cannot quit or have mental disorders, or suffer from epilepsy and need treatment;
• Those with poor blood pressure control;
• People with poor diabetes control;

Sponsors & Collaborators

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

Study Sites (14)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

NOT YET RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 519041, China

NOT YET RECRUITING

The Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 67000, China

NOT YET RECRUITING

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, 063000, China

NOT YET RECRUITING

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

NOT YET RECRUITING

Nanchang University First Affiliated Hospital

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Heze Municipal Hospital

Heze, Shandong, 27400, China

NOT YET RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

NOT YET RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300192, China

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Injections, Subcutaneous

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

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: September 9, 2025
• First Posted: September 18, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-06

Locations

CN (14)