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

Relapsed/Refractory Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400876
• Other study ID #: TQB2618-AK105-Ib-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 9, 2022
• Est. completion date: October 2023

Study information

• Verified date: June 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Tongyu Lin, Doctor
• Phone: 18108243837
• Email: tongyulin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: October 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Relapsed/Refractory Lymphoma

Intervention

Drug:
• TQB2618 injection
TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3)
• Penpulimab injection
Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose limiting toxicity/DLT	The relevant adverse reactions occurred within the first cycle	From the first injection up to 3 weeks
Primary	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
Primary	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	complete remission rate/CRR	Percentage of participants achieving complete response	From the first injection up to 96 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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