Back to resultsTo Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma
Primary Purpose
Relapsed/Refractory Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB2618 injection
Penpulimab injection
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Lymphoma
Eligibility Criteria
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- 7 Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.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.
Sites / Locations
- Sichuan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQB2618 injction+penpulimab injection
Arm Description
TQB2618 injection with penpulimab injection, 21 days as a treatment cycle
Outcomes
Primary Outcome Measures
dose limiting toxicity/DLT
The relevant adverse reactions occurred within the first cycle
recommended phase II dose/RP2D
The dose of TQB2618 injection which is recommended to use during phase II clinical trial
Overall response rate (ORR) based on 2014 Lugano
Percentage of participants achieving complete response (CR) and partial response (PR).
Secondary Outcome Measures
complete remission rate/CRR
Percentage of participants achieving complete response
Disease control rate/DCR
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of Response (DOR)
The time when the participants first achieved CR or PR to disease progression or death from any cause.
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.
Overall survival/OS
OS defined as the time from randomization until the death from any cause
Peak time/Tmax
The time to peak concentration
Peak concentration (Cmax)
Maximum plasma drug concentration
Half-life /T1/2
The time it takes for the drug's concentration in the body to drop by half
Receptor Occupancy/RO
The extent to which antibody drugs occupy cell surface targets
Incidence of Anti-Drug antibody and neutralizing antibodies
The incidence of anti-drug antibody and neutralizing antibodies after administration of TQB2618 and penpulimab
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Full Information
NCT ID
NCT05400876
First Posted
May 16, 2022
Last Updated
February 10, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05400876
Brief Title
To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma
Official Title
Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Relapsed or Refractory Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQB2618 injction+penpulimab injection
Arm Type
Experimental
Arm Description
TQB2618 injection with penpulimab injection, 21 days as a treatment cycle
Intervention Type
Drug
Intervention Name(s)
TQB2618 injection
Intervention Description
TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3)
Intervention Type
Drug
Intervention Name(s)
Penpulimab injection
Intervention Description
Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)
Primary Outcome Measure Information:
Title
dose limiting toxicity/DLT
Description
The relevant adverse reactions occurred within the first cycle
Time Frame
From the first injection up to 3 weeks
Title
recommended phase II dose/RP2D
Description
The dose of TQB2618 injection which is recommended to use during phase II clinical trial
Time Frame
From the first injection up to 6 weeks
Title
Overall response rate (ORR) based on 2014 Lugano
Description
Percentage of participants achieving complete response (CR) and partial response (PR).
Time Frame
From the first injection up to 96 weeks
Secondary Outcome Measure Information:
Title
complete remission rate/CRR
Description
Percentage of participants achieving complete response
Time Frame
From the first injection up to 96 weeks
Title
Disease control rate/DCR
Description
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
From the first injection up to 96 weeks
Title
Duration of Response (DOR)
Description
The time when the participants first achieved CR or PR to disease progression or death from any cause.
Time Frame
From the first injection up to 120 weeks
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to 96 weeks
Title
Overall survival/OS
Description
OS defined as the time from randomization until the death from any cause
Time Frame
From date of randomization until the death from any cause, assessed up to 120 weeks
Title
Peak time/Tmax
Description
The time to peak concentration
Time Frame
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
Title
Peak concentration (Cmax)
Description
Maximum plasma drug concentration
Time Frame
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）
Title
Half-life /T1/2
Description
The time it takes for the drug's concentration in the body to drop by half
Time Frame
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)
Title
Receptor Occupancy/RO
Description
The extent to which antibody drugs occupy cell surface targets
Time Frame
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)
Title
Incidence of Anti-Drug antibody and neutralizing antibodies
Description
The incidence of anti-drug antibody and neutralizing antibodies after administration of TQB2618 and penpulimab
Time Frame
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)
Title
Adverse event rate
Description
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time Frame
Baseline up to 96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tongyu Lin, Doctor
Phone
18108243837
Email
tongyulin@hotmail.com
Facility Information:
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongyu Lin, Doctor
Phone
18108243837
Email
tongyulin@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma
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