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

NCT05400876 | Unknown Phase 1

• 1 other identifier: TQB2618-AK105-Ib-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

• complete remission rate/CRR

  From the first injection up to 96 weeks

• Disease control rate/DCR

  From the first injection up to 96 weeks

• Duration of Response (DOR)

  From the first injection up to 120 weeks

• Progression-free survival (PFS)

  Up to 96 weeks

• Overall survival/OS

  From date of randomization until the death from any cause, assessed up to 120 weeks

Study Arms (1)

TQB2618 injction+penpulimab injection

EXPERIMENTAL

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

Drug: TQB2618 injection; Drug: Penpulimab injection

Interventions

TQB2618 injection DRUG

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

TQB2618 injction+penpulimab injection

Penpulimab injection DRUG

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

TQB2618 injction+penpulimab injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• Cohort 3：Subjects with T lymphocyte non-Hodgkin lymphoma (T-NHL) who had previously received at least one systemic therapy.
• Subjects with measurable lesions as defined by Lugano2014.
• Aged 18-75 years ; Eastern Cooperative Oncology Group (ECOG) score:0 \~ 1; Expected survival ≥3 months.
• Laboratory indicators meet the requirements.
• Subjects voluntarily joined the study and signed the informed consent form.
• Non-pregnant or non-breastfeeding women; Negative pregnancy subjects.

You may not qualify if:

• 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.
• Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.
• Subjects with significant surgery or significant traumatic injury within 28 days before first injection (excluding needle biopsy or endoscopic biopsy).
• Subjects with long-term unhealed wounds or fractures.
• 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.
• Subjects with arterial/venous thrombosis within 6 months.
• Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.
• Subjects with any severe and/or uncontrolled disease.
• subjects with lymphoma originating from Central Nervous System, high-grade B-cell lymphoma or hemophagocytic syndrome during screening period.
• Subjects with violating Central Nervous System (CNS) .
• Subjects with allogeneic hematopoietic stem cell transplantation.
• Subjects with autologous hematopoietic stem cell transplantation or Chimeric Antigen Receptor T-Cell Immunotherapy(CAR-T) within 3 months before first injection.
• Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610042, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

penpulimab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Tongyu Lin, Doctor

CONTACT

18108243837; tongyulin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 2, 2022
• Study Start: June 9, 2022
• Primary Completion: May 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 14, 2023

Record last verified: 2022-06

Locations

CN (1)