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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a two-phase, open-label Phase Ib clinical trial to evaluate the safety and efficacy of TQB2618 injection combined with piamprilumab in patients with relapsed and refractory lymphoma

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.