Status:
UNKNOWN
To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Relapsed/Refractory Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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- 7 Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.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.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05400876
Start Date
June 9 2022
End Date
October 1 2023
Last Update
February 14 2023
Active Locations (1)
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1
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610042