Clinical trial NCT05400876: To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Relapsed/Refractory Lymphoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: dose limiting toxicity/DLT
timeFrame: From the first injection up to 3 weeks
measure: recommended phase II dose/RP2D
timeFrame: From the first injection up to 6 weeks
measure: Overall response rate (ORR) based on 2014 Lugano
timeFrame: From the first injection up to 96 weeks
Secondary outcomes:
measure: complete remission rate/CRR
timeFrame: From the first injection up to 96 weeks
measure: Disease control rate/DCR
timeFrame: From the first injection up to 96 weeks
measure: Duration of Response (DOR)
timeFrame: From the first injection up to 120 weeks
measure: Progression-free survival (PFS)
timeFrame: Up to 96 weeks
measure: Overall survival/OS
timeFrame: From date of randomization until the death from any cause, assessed up to 120 weeks
measure: Peak time/Tmax
timeFrame: 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
measure: Peak concentration (Cmax)
timeFrame: 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）
measure: Half-life /T1/2
timeFrame: 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)
measure: Receptor Occupancy/RO
timeFrame: 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)
measure: Incidence of Anti-Drug antibody and neutralizing antibodies
timeFrame: 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)
measure: Adverse event rate
timeFrame: Baseline up to 96 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
Study officials:
References: