Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

NCT04002622 | Terminated Phase 2

• 1 other identifier: TQB2450-II-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 18

Brief Summary

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Conditions

Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Percentage of subjects achieving complete response (CR) and partial response (PR).

  up to 96 weeks

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  up to 96 weeks

• Duration of Response (DOR)

  up to 96 weeks

• Disease Control Rate (DCR)

  up to 24 months

• Time to Response (TTR)

  up to 24 months

• Overall Survival (OS)

  up to 24 months

Study Arms (1)

TQB2450

EXPERIMENTAL

TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.

Drug: TQB2450

Interventions

TQB2450 DRUG

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

TQB2450

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically confirmed relapsed or refractory primary mediastinal large B-cell lymphoma.
• \. 18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy \> 3 months.
• \. At least one measurable lesion. 4. Left ventricular ejection fraction (LVEF) measured by the cardiac echocardiography ≥ 50%.
• \. Screening laboratory values must meet the following criteria:hemoglobin ≥ 80 g/L; neutrophils ≥ 1.5\*10\^9/L; platelets ≥ 100 x 10\^9/ L.
• \. Understood and signed an informed consent form.

You may not qualify if:

• \. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
• \. Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• \. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.
• \. Has received emergency cytoreductive surgery to control tumors. 5. Has received allogeneic hematopoietic stem cell transplantation within the last 5 years.
• \. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
• \. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include basal cell skin cancer, squamous cell carcinoma of skin, melanoma skin and cancer carcinoma in situ of the cervix.
• \. Has definite central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal invasion or spinal cord compression.
• \. Has any active autoimmune disease or a history of autoimmune disease. 10. Has serious or uncontrolled diseases such as history of chronic heart failure.
• \. Has any active autoimmune disease or a history of autoimmune disease. 12. Has received blood transfusion, erythropoietin granulocyte colony stimulating factor(G -CSF)，or Granulocyte macrophage colony stimulating factor(GM-CSF) within 4 weeks before the first dose.
• \. Has vaccinated with vaccines or attenuated vaccines within 4 weeks before the first dose.
• \. Has received surgery, or unhealed wounds within 4 weeks before the first dose.
• \. Has Hepatic, renal, blood coagulation dysfunction. 16. Has interstitial lung disease or non-infectious pneumonia and present residual lesions.
• \. Has received systemic treatment for active infection before the first dose.
• \. Has active or latent tuberculosis. 19. Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus DNA copy number \> upper limit of normal.
• \. Human immunodeficiency virus antibody positive , hepatitis C antibody (HCV-Ab) and hepatitis C virus DNA copy number \> upper limit of normal.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (18)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Fifth Medical Center of the Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100071, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100083, China

Location

Peking University Third Hospital

Beijin, Beijing Municipality, 100191, China

Location

Peking Hospital

Beijin, Beijing Municipality, 100730, China

Location

Union Medical College Hospital Affiliated to Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Henan People's Hospital

Zhengzhou, Henan, 450003, China

Location

Hunan Canser Hospital

Changsha, Hunan, 410006, China

Location

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266005, China

Location

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

Shanghai Tumor Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

Zhejiang Tumor Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: June 28, 2019
• Study Start: August 6, 2019
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

CN (18)