Relapsed/Refractory Lymphoma
Conditions
Brief summary
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
Interventions
TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3)
Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1 Subjects with pathologically proven with relapsed or refractory lymphoma and with disease progression during or after the last treatment or no objective response confirmed after adequate treatment. * 2 Cohort 1: Subjects with Classical Hodgkin lymphoma (cHL) who had previously received at least twice systemic therapy and are resistant to PD-1 or PD-L1. * 3 Cohort 2: Subjects with B lymphocyte non-Hodgkin lymphoma (B-NHL) who had previously received at least twice systemic therapy containing anti-CD20-targeted therapy. * 4 Cohort 3：Subjects with T lymphocyte non-Hodgkin lymphoma (T-NHL) who had previously received at least one systemic therapy. * 5 Subjects with measurable lesions as defined by Lugano2014. * 6 Aged 18-75 years ; Eastern Cooperative Oncology Group (ECOG) score:0 \ 1; Expected survival ≥3 months. * 7 Laboratory indicators meet the requirements. * 8 Subjects voluntarily joined the study and signed the informed consent form. * 9 Non-pregnant or non-breastfeeding women; Negative pregnancy subjects.
Exclusion criteria
* 1 Subjects who have developed or is currently suffering from other malignancies within 3 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ. * 2 Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy. * 3 Subjects with significant surgery or significant traumatic injury within 28 days before first injection (excluding needle biopsy or endoscopic biopsy). * 4 Subjects with long-term unhealed wounds or fractures. * 5 Subjects with the high risk of bleeding or bleeding history or subjects with bleeding event (≥Common Terminology Criteria for Adverse Events Grade 3) within 4 weeks before first injection. * 6 Subjects with arterial/venous thrombosis within 6 months. * 7 Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders. * 8 Subjects with any severe and/or uncontrolled disease. * 9 subjects with lymphoma originating from Central Nervous System, high-grade B-cell lymphoma or hemophagocytic syndrome during screening period. * 10 Subjects with violating Central Nervous System (CNS) . * 11 Subjects with allogeneic hematopoietic stem cell transplantation. * 12 Subjects with autologous hematopoietic stem cell transplantation or Chimeric Antigen Receptor T-Cell Immunotherapy(CAR-T) within 3 months before first injection. * 13 Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dose limiting toxicity/DLT | From the first injection up to 3 weeks | The relevant adverse reactions occurred within the first cycle |
| recommended phase II dose/RP2D | From the first injection up to 6 weeks | The dose of TQB2618 injection which is recommended to use during phase II clinical trial |
| Overall response rate (ORR) based on 2014 Lugano | From the first injection up to 96 weeks | Percentage of participants achieving complete response (CR) and partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to 96 weeks | 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. |
| Overall survival/OS | From date of randomization until the death from any cause, assessed up to 120 weeks | OS defined as the time from randomization until the death from any cause |
| Peak time/Tmax | 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 | The time to peak concentration |
| Peak concentration (Cmax) | 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） | Maximum plasma drug concentration |
| complete remission rate/CRR | From the first injection up to 96 weeks | Percentage of participants achieving complete response |
| Receptor Occupancy/RO | 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) | The extent to which antibody drugs occupy cell surface targets |
| Incidence of Anti-Drug antibody and neutralizing antibodies | 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) | The incidence of anti-drug antibody and neutralizing antibodies after administration of TQB2618 and penpulimab |
| Adverse event rate | Baseline up to 96 weeks | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). |
| Half-life /T1/2 | 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) | The time it takes for the drug's concentration in the body to drop by half |
| Disease control rate/DCR | From the first injection up to 96 weeks | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). |
| Duration of Response (DOR) | From the first injection up to 120 weeks | The time when the participants first achieved CR or PR to disease progression or death from any cause. |
Countries
China
Contacts
Primary ContactTongyu Lin, Doctor
Outcome results
None listed