Multiple MyelomaPhase 1NCT06700395
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
A Phase 1 study testing TQB2029 injection in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with… 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?
- TQB2029 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesChina
- Study dates
- 28 Nov 2024to Mar 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
- Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
- Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period.
- Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria
- There are measurable lesions present
- The function of main organs is normal.
- Subjects need to adopt effective methods of contraception.
Who cannot join
- Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
- Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication
- Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication
- Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment
- Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication
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- Subjects who have experienced arterial/venous thrombotic event occurred within 6 months prior to the first administration
- Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders;
- Subjects with any severe and/or uncontrolled disease
- According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China hospital, Sichuan university
Chengdu, Sichuan, 610000
Ting Niu, Doctor, 028-85423046, tingniu@sina.com
- Not yet recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Peng Liu, Doctor, 021-60267405, Liu.peng@zs-hospital.sh.cn
About this study
Official title: Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma
This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- TQB2029 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.
TQB2029 injectionDrug
TQB2029 for injection is a bispecific antibody targeting G Protein-Coupled Receptor, Class C, Group 5, Member D (GPRC5D) and Cluster of Differentiation 3 (CD3) . By recruiting and activating CD3 positive T cells, it induces T cells to kill malignant plasma cells expressing GPRC5D, thereby inhibiting the occurrence and development of tumors.
| Study group | Role | What they receive |
|---|---|---|
| TQB2029 injection | Experimental | TQB2029 injection, 28 days as a treatment cycle. Receives: Drug: TQB2029 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
DLT refers to any of the following events in the first administration of TQB2029 for injection to the end of the first treatment cycle (C1D28) that the investigator and the sponsor consider to be related to the treatment of TQB2029 for injection.
Measured: During the first 28 days
Maximum tolerated dose (MTD)
After the experiment is completed, sequential regression is used to determine the maximum tolerated dose (MTD). Specifically, calculate the toxicity rate of each dose group and select the dose closest to the target toxicity rate as MTD.
Measured: Up to 18 months
Recommended Phase II Dose (RP2D)
Determine RP2D based on target toxicity rates for each dose group
Measured: Up to 18 months
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) v5.0.
Measured: Up to 18 months
Secondary outcomes (17)
Elimination half-life (to be used in one-or non- compartmental model) (t1/2)
t1/2 is time it takes for the blood concentration of TQB2029 or metabolite(s) to drop by half.
Measured: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB2029 or metabolite(s).
Measured: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB2029 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Measured: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Apparent clearance rate (CL/F)
The apparent clearance rate is used to predict dynamic distribution rates and evaluate the dynamics of nutrients.
Measured: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Volume of distribution(Vz/F)
Refers to the volume of bodily fluids required for drugs to be distributed in the body according to the plasma drug concentration at the time when the drug reaches dynamic equilibrium in the body.
Measured: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Blood drug trough concentration (Cmin)
Describe the minimum value of drug concentration.
Measured: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Exploring the correlation between changes in cytokine levels, lymphocyte subpopulation levels, and therapeutic efficacy
Pharmacodynamic indicators：The levels of peripheral blood serum cytokines (IL-2, IL-6, IL-8, IL-10, Interferon gamma (IFN - γ), tumor necrosis factor-α (TNF - α), interleukin 2 receptor alpha (IL-2R α), interleukin 2 receptor beta (IL-2R β), IL-2R γ, lymphocyte subsets, T cell activation markers (percentage of Cluster of (Differentiation) 25+T cells, percentage of Ki67+T cells), and the expression levels of Programmed cell death 1 (PD-1), T-cell immunoglobulin and mucin domain 3 (TIM-3), Lymphocyte-activation gene 3 (LAG-3), cytotoxic T-lymphocyte associated protein 4 (CTLA-4) on the surface of T cells.
Measured: The first and second treatment cycle: 0, 2, 6, 24, 48, 72 hours after dosing on the first day, 0 hours on the 15th day;The first treatment cycle: 0 hours on the 8th day;0 hours on the 22th day;The third and fourth treatment cycle: 0 hours on the 1st day.
Immunogenicity analysis- positive anti drug antibodies (ADA)
Describe the number, proportion, and 95% confidence interval of positive anti drug antibodies (ADA) after medication, as well as the time and titer of ADA production
Measured: The first, third, sixth, twelfth treatment cycle: 0 hours on the first day;and End of Treatment Visit (EOT)
Overall response rate (ORR)
Proportion of subjects with best response as PR, VGPR, CR, sCR.
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)
Proportion of subjects whose best response is CR.
Measured: Up to 18 months
Strict Complete Response (sCR) Rate
Proportion of subjects whose best response is 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start28 Nov 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 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
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700395
- Sponsor's protocol ID
- TQB2029-I-01
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2024
- Last updated
- 6 Dec 2024
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06700395
- Acronym / sponsor ID
- TQB2029-I-01
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Nov 2024 (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.
This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects 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 |
|---|---|---|
| TQB2029 injection | Experimental | Drug: TQB2029 injectionTQB2029 injection, 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 (6 listed)
- Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
- Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period.
- Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria
- There are measurable lesions present
- The function of main organs is normal.
Key exclusion criteria (10 listed)
- Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
- Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication
- Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication
- Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment
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 |
|---|---|---|
| TQB2029 injectionTQB2029 for injection is a bispecific antibody targeting G Protein-Coupled Receptor, Class C, Group 5, Member D (GPRC5D) and Cluster of Differentiation 3 (CD3) . By recruiting and activating CD3 positive T cells, it induces T cells to kill malignant plasma cells expressing GPRC5D, thereby inhibiting the occurrence and development of tumors. | Drug | TQB2029 injection |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: During the first 28 days
DLT refers to any of the following events in the first administration of TQB2029 for injection to the end of the first treatment cycle (C1D28) that the investigator and the sponsor consider to be related to the treatment of TQB2029 for injection.
Maximum tolerated dose (MTD)
Time frame: Up to 18 months
After the experiment is completed, sequential regression is used to determine the maximum tolerated dose (MTD). Specifically, calculate the toxicity rate of each dose group and select the dose closest to the target toxicity rate as MTD.
Recommended Phase II Dose (RP2D)
Time frame: Up to 18 months
Determine RP2D based on target toxicity rates for each dose group
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 18 months
Assessed by the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) v5.0.
17 secondary outcomes
Elimination half-life (to be used in one-or non- compartmental model) (t1/2)
Time frame: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Maximum (peak) plasma drug concentration (Cmax)
Time frame: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Apparent clearance rate (CL/F)
Time frame: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Volume of distribution(Vz/F)
Time frame: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Blood drug trough concentration (Cmin)
Time frame: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.
Exploring the correlation between changes in cytokine levels, lymphocyte subpopulation levels, and therapeutic efficacy
Time frame: The first and second treatment cycle: 0, 2, 6, 24, 48, 72 hours after dosing on the first day, 0 hours on the 15th day;The first treatment cycle: 0 hours on the 8th day;0 hours on the 22th day;The third and fourth treatment cycle: 0 hours on the 1st day.
Immunogenicity analysis- positive anti drug antibodies (ADA)
Time frame: The first, third, sixth, twelfth treatment cycle: 0 hours on the first day;and End of Treatment Visit (EOT)
Overall response rate (ORR)
Time frame: Up to 18 months
Very good partial response rate (VGPR)
Time frame: Up to 18 months
Complete Response (CR)
Time frame: Up to 18 months
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
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 6 Dec 2024.
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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.
2 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 TQB2029 injection in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 2 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 6 inclusion and 10 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Ting Niu, Doctor (028-85423046, tingniu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) (time frame: During the first 28 days). The study lists 4 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 6 Dec 2024.