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

CTTQ

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Relapsed/Refractory Lymphoma

Treatments

Drug: Penpulimab injection

Drug: TQB2618 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05400876

TQB2618-AK105-Ib-01

Details and patient eligibility

About

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

Enrollment

92 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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) .
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.