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

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

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory Lymphoma
• Intervention / Treatment: Drug: TQB2618 injection; Drug: Penpulimab injection

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tongyu Lin, Doctor; Phone Number: 18108243837; Email: tongyulin@hotmail.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610042
      • Recruiting
      • Sichuan Cancer Hospital
      • Contact: Tongyu Lin, Doctor; Phone Number: 18108243837; Email: tongyulin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TQB2618 injction+penpulimab injection; TQB2618 injection with penpulimab injection, 21 days as a treatment cycle	Drug: TQB2618 injection; TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3); Drug: Penpulimab injection; Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).	Baseline up to 96 weeks
complete remission rate/CRR	Percentage of participants achieving complete response	From the first injection up to 96 weeks
Disease control rate/DCR	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	From the first injection up to 96 weeks
Duration of Response (DOR)	The time when the participants first achieved CR or PR to disease progression or death from any cause.	From the first injection up to 120 weeks
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.	Up to 96 weeks
Overall survival/OS	OS defined as the time from randomization until the death from any cause	From date of randomization until the death from any cause, assessed up to 120 weeks
Peak time/Tmax	The time to peak concentration	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
Peak concentration (Cmax)	Maximum plasma drug concentration	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）
Half-life /T1/2	The time it takes for the drug's concentration in the body to drop by half	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)
Receptor Occupancy/RO	The extent to which antibody drugs occupy cell surface targets	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)
Incidence of Anti-Drug antibody and neutralizing antibodies	The incidence of anti-drug antibody and neutralizing antibodies after administration of TQB2618 and penpulimab	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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 9, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: TQB2618-AK105-Ib-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No