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UNKNOWNPHASE1/PHASE2

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

Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Relapsed or Refractory Lymphoma

NCT05400876•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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) .
+3 more criteria

Locations (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

June 9, 2022

Primary Completion Date

May 1, 2023

Completion Date

October 1, 2023

Last Updated

February 14, 2023

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory Lymphoma

Interventions

TQB2618 injection

DRUG

Penpulimab injection

DRUG

Contacts

Tongyu Lin, Doctor

CONTACT

18108243837 tongyulin@hotmail.com

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TERMINATEDEARLY_PHASE1

A Study of OVV-01 Injection in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma

A Study of OVV-01 Injection in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors

Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function