To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma

NCT ID: NCT05400876

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2023-10-31

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

Conditions

Relapsed/Refractory Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2618 injction+penpulimab injection

TQB2618 injection with penpulimab injection, 21 days as a treatment cycle

Group Type: EXPERIMENTAL

TQB2618 injection

Intervention Type: DRUG

TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3)

Penpulimab injection

Intervention Type: DRUG

Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)

Interventions

TQB2618 injection

TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3)

Intervention Type: DRUG

Penpulimab injection

Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tongyu Lin, Doctor

Role: CONTACT

tongyulin@hotmail.com

18108243837

Facility Contacts

Tongyu Lin, Doctor

Role: primary

tongyulin@hotmail.com

18108243837

Other Identifiers

TQB2618-AK105-Ib-01

Identifier Type: -

Identifier Source: org_study_id