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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2029 injection | Experimental | TQB2029 injection, 28 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2029 injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 18 months |
| Recommended Phase II Dose (RP2D) | Determine RP2D based on target toxicity rates for each dose group | 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. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Niu, Doctor | Contact | 028-85423046 | tingniu@sina.com | |
| Peng Liu, Doctor | Contact | 021-60267405 | Liu.peng@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital of Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Maximum (peak) plasma drug concentration (Cmax) | Cmax is the maximum plasma concentration of TQB2029 or metabolite(s). | 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. | 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. | 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. | 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. | 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. | 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 | 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. | Up to 18 months |
| Very good partial response rate (VGPR) | Proportion of subjects whose best response is VGPR, CR, sCR | Up to 18 months |
| Complete Response (CR) | Proportion of subjects whose best response is CR. | Up to 18 months |
| Strict Complete Response (sCR) Rate | Proportion of subjects whose best response is sCR. | 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. | 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). | 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. | 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. | Up to 18 months |
| Overall survival (OS) | Time from first dose of study drug to date of death from any cause. | Up to 18 months |
| West China hospital, Sichuan university | Recruiting | Chengdu | Sichuan | 610000 | China |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |