Multiple MyelomaPhase 1NCT07179679
A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors
A Phase 1 study testing TQB2934 injection (subcutaneous injection) in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 14 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- TQB2934 injection (subcutaneous injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 14 sitesChina
- Study dates
- 9 Dec 2025to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;
- 18 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;
Who cannot join
- 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;
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- 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;
- People with severe bacterial, viral or systemic fungal infections that are active or uncontrollable within 4 weeks before the first medication;
- People with hepatitis or decompensated cirrhosis;
- People with active tuberculosis, a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radioactive pneumonia that needs treatment, or active pneumonia with clinical symptoms;
- People who have had or are currently suffering from asthma within 2 years before the first medication, or who have chronic obstructive pulmonary disease (COPD) and have a forceful exhalation volume (FEV1) in the first second <50% expected value;
- Those who have had asthma within 2 years before the first medication or are currently suffering from asthma;
- People suffering from major cardiovascular diseases;
- Have a history of immunodeficiency;
- According to the researcher's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study, or subjects who believe there are other reasons that are not suitable for enrollment;
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Not yet recruiting
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 67000
Zhihua Zhang, Master, 15633142905, zzhangzhihua@163.com
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yao Liu, Doctor, 13228684685, liuyao101709@163.com
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Yongqiang Wei, Doctor, 13902209760, wyq1973@163.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 519041
Peilong Lai, 13570931198, lai_peilong@163.com
- Not yet recruiting
Heze Municipal Hospital
Heze, Shandong, 27400
Yuqi Sang, Doctor, 19953030611, sangyuqi1966@163.com
- Not yet recruiting
Nanchang University First Affiliated Hospital
Nanchang, Jiangxi, 330006
Fei Li, Doctor, 13970038386
- Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Daiyuan Ma, Doctor, 13990889661, mdylx@163.com
- Recruiting
Nanjing Drum Tower hospital
Nanjing, Jiangsu, 210008
Bing Chen, Doctor, 13951806490, chenbinggcp@163.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Xiaoyan Qu, Doctor, 13770720898, quxiaoyan205@163.com
- Not yet recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Peng Liu, Doctor, 021-60267405, Liu.peng@zs-hospital.sh.cn
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Bingzong Li, Doctor, 13776054037, lbzwz0907@hotmail.com
- Not yet recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000
Zhenyu Yan, Doctor, 15931508262, hbyzy2022@163.com
- Not yet recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300192
Xingli Zhao, Doctor, 13752255454, insectzhao@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Pengcheng He, Doctor, 18991232609, Hepc_gcp@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety and Pharmacokinetics of TQB2934 Subcutaneous Preparation for Injection in Subjects With Malignant Plasma Cell Tumors
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
- Being tested
- TQB2934 injection (subcutaneous injection)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TQB2934 injection (subcutaneous injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak time (Tmax)
It refers to the time when TQB2934 (subcutaneous injection) is administered for injection to reach the maximum blood drug concentration.
Measured: Within 120 hours after administration
Peak drug concentration (Cmax)
It refers to the highest blood drug concentration after administration of TQB2934 (subcutaneous injection).
Measured: 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.
Measured: 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.
Measured: Within 120 hours after administration
Apparent clearance (CL)
Apparent clearance (CL)
Measured: 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
Measured: Up to 24 months
Secondary outcomes (11)
Overall response rate (ORR)
Proportion of subjects with best response as Partial relief (PR), Very good partial relief (VGPR), Complete Response (CR), Strict Complete Response (sCR)
Measured: Up to 24 months
Clinical benefit rate (CBR)
Proportion of subjects with best response as Minor relief (MR), PR(Partial relief), VGPR(Very good partial relief), CR (Complete Response), sCR (Strict Complete Response)
Measured: Up to 24 months
very good partial response rate (VGPR)
Proportion of subjects whose best response is VGPR, CR, sCR;
Measured: Up to 24 months
Complete Response (CR) Rate
Proportion of subjects whose best response is CR
Measured: Up to 24 months
Strict Complete Response (sCR)
Proportion of subjects whose best response is sCR;
Measured: Up to 24 months
Negative rate of minimal residual disease (MRD)
The proportion of subjects with negative MRD (<10-5, multicolor flow cytometry or next-generation sequencing) at any time point from the first administration of the trial drug to disease progression or before receiving new anti-tumor therapy;
Measured: Up to 24 months
Duration of remission (DOR)
For all subjects whose best response was PR, VGPR, CR, sCR, the time from the date of first achieving PR, VGPR, CR, sCR to the date of first definite disease progression or (any cause) death(whichever occurs first).
Measured: Up to 24 months
Time to first remission (TTR)
Among all the subjects whose best response is PR, VGPR, CR, sCR, the time from the first administration of the test drug to the date of the first PR and above remission.
Measured: Up to 24 months
Progression-free survival (PFS)
The time between the first dose of the trial drug and the date of first definite disease progression or death (from any cause), whichever occurs first.
Measured: Up to 24 months
Overall survival (OS)
Time from first dose of study drug to date of death from any cause.
Measured: Up to 24 months
Antidrug antibody (ADA) incidence and changes over time
Positive incidence of anti-drug antibodies and changes over time
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start9 Dec 2025
- Primary completionOct 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179679
- Sponsor's protocol ID
- TQB2934-I-02
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety and Pharmacokinetics of TQB2934 Subcutaneous Preparation for Injection in Subjects With Malignant Plasma Cell Tumors
- ClinicalTrials.gov ID
- NCT07179679
- Acronym / sponsor ID
- TQB2934-I-02
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2934 injection (subcutaneous injection) | Experimental | Drug: TQB2934 injection (subcutaneous injection)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;
- 18 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2934 injection (subcutaneous injection)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. | Drug | TQB2934 injection (subcutaneous injection) |
Primary outcome
Peak time (Tmax)
Time frame: Within 120 hours after administration
It refers to the time when TQB2934 (subcutaneous injection) is administered for injection to reach the maximum blood drug concentration.
Peak drug concentration (Cmax)
Time frame: Within 120 hours after administration
It refers to the highest blood drug concentration after administration of TQB2934 (subcutaneous injection).
Area under the plasma concentration-time curve (AUC0-last)
Time frame: Within 120 hours after administration
To characterize the pharmacokinetics of TQB2934 by assessment of area under the plasma concentration time curve.
Elimination half-life (t1/2)
Time frame: Within 120 hours after administration
t1/2 is time it takes for the blood concentration of TQB2934 to drop by half.
Apparent clearance (CL)
Time frame: Within 120 hours after administration
Apparent clearance (CL)
Adverse events(AEs)
Time frame: Up to 24 months
Incidence and severity of subjects with adverse events(AEs), Abnormal laboratory test value and serious adverse events
11 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 24 months
Clinical benefit rate (CBR)
Time frame: Up to 24 months
very good partial response rate (VGPR)
Time frame: Up to 24 months
Complete Response (CR) Rate
Time frame: Up to 24 months
Strict Complete Response (sCR)
Time frame: Up to 24 months
Negative rate of minimal residual disease (MRD)
Time frame: Up to 24 months
Duration of remission (DOR)
Time frame: Up to 24 months
Time to first remission (TTR)
Time frame: Up to 24 months
Progression-free survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Antidrug antibody (ADA) incidence and changes over time
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2934 injection (subcutaneous injection) in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Liu, Doctor (021-60267405, Liu.peng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak time (Tmax) (time frame: Within 120 hours after administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.