Multiple MyelomaPhase 1NCT05646758
A Clinical Trial of TQB2934 for Injection in Multiple Myeloma Subjects
A Phase 1 study testing TQB2934 injection in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
Trial 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… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 7 sitesChina
- Study dates
- 17 Mar 2023to Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 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;
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- 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;
Who cannot join
- 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.;
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- 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;
- A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of solid organ transplantation (except corneal transplantation), and active or autoimmune patients who need to receive systemic immunosuppressant therapy;
- Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L);
- Suffering from epilepsy and needing treatment;
- Tumor-related symptoms and treatment:
- Diagnosed with amyloidosis, plasma cell leukemia (PCL, peripheral plasma cell ratio ≥ 20%, or absolute plasma cell count ≥ 2×109/L), Waldenstrom macroglobulinemia (WM) or POEMS syndrome;
- Known multiple myeloma meningeal or central nervous system invasion or highly suspected meningeal or central nervous system invasion but cannot be identified;
- Previously received BCMA-targeted therapy;
- Previously received allogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T (CAR-T), CAR-NK cell therapy; or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks before the first drug;
- Received targeted therapy, cytotoxic drugs or any antibody therapy within 3 weeks before the first medication; received proteasome inhibitor therapy or radiotherapy within 2 weeks before the first medication; received immunomodulator therapy within 1 week before the first medication.(Prophylaxis to prevent infusion-related reactions prior to study drug administration)(Calculate the washout period from the end of the last treatment);
- research treatment related:
- History of live attenuated vaccine vaccination within 28 days before the first dose or planned live attenuated live vaccine vaccination during the study;
- Unexplained severe allergy history, known allergy to monoclonal antibody drugs or exogenous human immunoglobulin, or known allergy to TQB2934 for injection or excipients in pharmaceutical preparations;
- Those who have participated in other anti-tumor drug clinical trials within 4 weeks before the first drug use or have not exceeded 5 drug half-lives;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Junling Zhuang, Doctor, +86 (010) 88068210, zhuangjunling@hotmail.com
- Recruiting
Sun Yat-Sen University Cancer Canter
Guangzhou, Guangdong, 510060
Zhongjun Xia, Master, +86 13602713223, xiazj@sysucc.org.cn
- Recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, 250117
Zengjun Li, Doctor, 13642138692, zengjunli@163.com
Shuqin Ni, Doctor, 15553115936, nsq163@163.com
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Peng Liu, Doctor, +86 (021)60267405, Liu.peng@zs-hospital.sh.cn
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Bingzong Li, Doctor, 13776054037, lbzwz0907@hotmail.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Songfu Jiang, Master, 15305770033, Jiangsongfu@189.cn
- Recruiting
The Henan Cancer Hospital
Zhengzhou, Henan, 450008
Baijun Fang, Doctor, 13526607830, fdation@126.com
About this study
Official title: A Phase I Clinical Trial Evaluating the Tolerance and Pharmacokinetics of TQB2934 for Injection in Multiple Myeloma Subjects
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
- Being tested
- TQB2934 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 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TQB2934 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Maximum Tolerated Dose (MTD)
After the trial, ordinal regression was used to determine the maximum tolerated dose (MTD)
Measured: 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.
Measured: Up to 18 months
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) will be reported for safety evaluation.
Measured: Up to 18 months
Incidence and severity abnormal laboratory test value
Incidence and severity abnormal laboratory test value will be reported for safety evaluation.
Measured: Up to 18 months
Secondary outcomes (23)
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB2934 to drop by half.
Measured: 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: 120 hours after administration
Apparent clearance (CL)
Apparent clearance (CL) after administration
Measured: 120 hours after administration
Terminal phase apparent volume of distribution (Vz)
Terminal phase apparent volume of distribution (Vz)
Measured: 120 hours after administration
Plasma trough concentration (Cmin)
Cmin is the minimum plasma concentration of TQB2934.
Measured: 120 hours after administration
Overall response rate (ORR)
Proportion of subjects with best response as PR(Partial relief), VGPR(Very good partial relief), CR(Complete Response), sCR(Strict Complete Response)
Measured: Up to 18 months
Clinical benefit rate (CBR)
Proportion of subjects with best response as MR(Minor relief), PR(Partial relief), VGPR(Very good partial relief), CR(Complete Response), sCR(Strict Complete Response)
Measured: Up to 18 months
Very good partial response rate (VGPR)
Proportion of subjects whose best response is VGPR, CR, sCR;
Measured: Up to 18 months
Complete Response (CR) / Strict Complete Response (sCR) Rate
Proportion of subjects whose best response is CR and sCR;
Measured: Up to 18 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 18 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 18 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 18 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 18 months
Overall survival (OS)
Time from first dose of study drug to date of death from any cause.
Measured: Up to 18 months
Disease status was determined using the International Myeloma Working Group (IMWG) 2016 criteria
Disease status was determined using the International Myeloma Working Group (IMWG) 2016 criteria
Measured: Up to 18 months
Antidrug antibody (ADA) incidence
Positive incidence of anti-drug antibodies
Measured: Up to 18 months
Peripheral blood soluble BCMA (sBCMA) level
The level of soluble BCMA (sBCMA) in peripheral blood is the pharmacodynamic index of TQB2934.
Measured: Up to 18 months
Receptor occupancy rate (RO)
The receptor occupation (RO) of TQB2934 on immune cells in human body
Measured: Up to 18 months
Cytokine Interleukin 2 (IL-2) levels
The level of cytokine interleukin 2 (IL-2) is the pharmacodynamic index of TQB2934.
Measured: Up to 18 months
Cytokine Interleukin 6 (IL-6) levels
The level of cytokine interleukin 6 (IL-6) is the pharmacodynamic index of TQB2934.
Measured: Up to 18 months
Cytokine Interleukin 10 (IL-10) levels
The level of cytokine interleukin 10 (IL-10) is the pharmacodynamic index of TQB2934.
Measured: Up to 18 months
Cytokine Interferon γ (IFN-γ) levels
The level of cytokine Interferon γ (IFN-γ) is the pharmacodynamic index of TQB2934.
Measured: Up to 18 months
Cytokine Interferon α (IFN-α) levels
The level of cytokine Interferon α (IFN-α) is the pharmacodynamic index of TQB2934.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start17 Mar 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (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 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646758
- Sponsor's protocol ID
- TQB2934-I-01
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating the Tolerance and Pharmacokinetics of TQB2934 for Injection in Multiple Myeloma Subjects
- ClinicalTrials.gov ID
- NCT05646758
- Acronym / sponsor ID
- TQB2934-I-01
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Dec 2022 (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-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.
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 | Experimental | Drug: TQB2934 injectionintravenous 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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;
Key exclusion criteria (29 listed)
- Comorbidities and medical history:
- Tumor-related symptoms and treatment:
- research treatment related:
- Those who have participated in other anti-tumor drug clinical trials within 4 weeks before the first drug use or have not exceeded 5 drug half-lives;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons;
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 injectionTQB2934 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. | Drug | TQB2934 injection |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 18 months
DLT refers to any of the toxicity events in the first administration of TQB2934 for injection to the end of the first treatment cycle.
Maximum Tolerated Dose (MTD)
Time frame: Up to 18 months
After the trial, ordinal regression was used to determine the maximum tolerated dose (MTD)
Incidence and severity of serious adverse events (AEs)
Time frame: Up to 18 months
Incidence and severity of serios adverse events (AEs) will be reported for safety evaluation.
Incidence and severity of adverse events (AEs)
Time frame: Up to 18 months
Incidence and severity of adverse events (AEs) will be reported for safety evaluation.
Incidence and severity abnormal laboratory test value
Time frame: Up to 18 months
Incidence and severity abnormal laboratory test value will be reported for safety evaluation.
23 secondary outcomes
Elimination half-life (t1/2)
Time frame: 120 hours after administration
Area under the plasma concentration-time curve (AUC0-last)
Time frame: 120 hours after administration
Apparent clearance (CL)
Time frame: 120 hours after administration
Terminal phase apparent volume of distribution (Vz)
Time frame: 120 hours after administration
Plasma trough concentration (Cmin)
Time frame: 120 hours after administration
Overall response rate (ORR)
Time frame: Up to 18 months
Clinical benefit rate (CBR)
Time frame: Up to 18 months
Very good partial response rate (VGPR)
Time frame: Up to 18 months
Complete Response (CR) / Strict Complete Response (sCR) Rate
Time frame: Up to 18 months
Negative rate of minimal residual disease (MRD)
Time frame: Up to 18 months
Duration of remission (DOR)
Time frame: Up to 18 months
Time to first remission (TTR)
Time frame: Up to 18 months
Progression-free survival (PFS)
Time frame: Up to 18 months
Overall survival (OS)
Time frame: Up to 18 months
Disease status was determined using the International Myeloma Working Group (IMWG) 2016 criteria
Time frame: Up to 18 months
Antidrug antibody (ADA) incidence
Time frame: Up to 18 months
Peripheral blood soluble BCMA (sBCMA) level
Time frame: Up to 18 months
Receptor occupancy rate (RO)
Time frame: Up to 18 months
Cytokine Interleukin 2 (IL-2) levels
Time frame: Up to 18 months
Cytokine Interleukin 6 (IL-6) levels
Time frame: Up to 18 months
Cytokine Interleukin 10 (IL-10) levels
Time frame: Up to 18 months
Cytokine Interferon γ (IFN-γ) levels
Time frame: Up to 18 months
Cytokine Interferon α (IFN-α) levels
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
7 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 in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 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 10 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
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?
Dose-limiting toxicity (DLT) (time frame: Up to 18 months). The study lists 5 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 18 Mar 2024.