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This is a two-phase, open-label Phase Ib clinical trial to evaluate the safety and efficacy of TQB2618 injection combined with Penpulimab in patients with relapsed and refractory lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2618 injction+penpulimab injection | Experimental | TQB2618 injection with penpulimab injection, 21 days as a treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2618 injection | Drug | TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| dose limiting toxicity/DLT | The relevant adverse reactions occurred within the first cycle | From the first injection up to 3 weeks |
| recommended phase II dose/RP2D | The dose of TQB2618 injection which is recommended to use during phase II clinical trial | From the first injection up to 6 weeks |
| Overall response rate (ORR) based on 2014 Lugano | Percentage of participants achieving complete response (CR) and partial response (PR). | From the first injection up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate/CRR | Percentage of participants achieving complete response | From the first injection up to 96 weeks |
| Disease control rate/DCR | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tongyu Lin, Doctor | Contact | 18108243837 | tongyulin@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 610042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41963080 | Derived | Hong H, Chen Z, Cui J, Zhang Q, Li P, Tao R, Huang H, Wang B, Li W, Wu H, Wei J, Su L, Zhang Z, Zhong M, Wang H, Wang C, Zhou H, Wang J, Dong M, Lin T. Anti-TIM-3 antibody TQB2618 in combination with penpulimab in relapsed or refractory classic Hodgkin lymphoma previously treated with PD-1/PD-L1 therapy: a multicenter, open-label, single-arm, phase Ib clinical trial. J Immunother Cancer. 2026 Apr 10;14(4):e014968. doi: 10.1136/jitc-2026-014968. |
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| Penpulimab injection | Drug | Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1) |
|
| From the first injection up to 96 weeks |
| Duration of Response (DOR) | The time when the participants first achieved CR or PR to disease progression or death from any cause. | From the first injection up to 120 weeks |
| Progression-free survival (PFS) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. cause. cause. PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | Up to 96 weeks |
| Overall survival/OS | OS defined as the time from randomization until the death from any cause | From date of randomization until the death from any cause, assessed up to 120 weeks |
| Peak time/Tmax | The time to peak concentration | Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.each cycle 21 days |
| Peak concentration (Cmax) | Maximum plasma drug concentration | Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.(each cycle 21 days) |
| Half-life /T1/2 | The time it takes for the drug's concentration in the body to drop by half | Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.(each cycle 21 days) |
| Receptor Occupancy/RO | The extent to which antibody drugs occupy cell surface targets | Cycle 1 day 1, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before administration and 30 minutes after administration and the day of disease progression(each cycle 21 days) |
| Incidence of Anti-Drug antibody and neutralizing antibodies | The incidence of anti-drug antibody and neutralizing antibodies after administration of TQB2618 and penpulimab | Cycle 1 day 1, Cycle 2 day 1, Cycle 4 day 1, Cycle 8 day 1,before administration and 30, 90 days after the last administration(each cycle 21 days) |
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Baseline up to 96 weeks |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000720860 | penpulimab |
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