Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)Phase 2NCT04002622
Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma
A Phase 2 study testing TQB2450 in people with Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
- What is being tested?
- TQB2450
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 18 sitesChina
- Study dates
- 6 Aug 2019to 21 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically confirmed relapsed or refractory primary mediastinal large B-cell lymphoma.
- 2. 18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy > 3 months.
- 3. At least one measurable lesion. 4. Left ventricular ejection fraction (LVEF) measured by the cardiac echocardiography ≥ 50%.
- 5. Screening laboratory values must meet the following criteria:hemoglobin ≥ 80 g/L; neutrophils ≥ 1.510^9/L; platelets ≥ 100 x 10^9/ L.
- 6. Understood and signed an informed consent form.
Who cannot join
- 1. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
- 2. 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.
- 3. 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.
- 4. Has received emergency cytoreductive surgery to control tumors. 5. Has received allogeneic hematopoietic stem cell transplantation within the last 5 years.
- 6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
- 7. 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.
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- 8. Has definite central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal invasion or spinal cord compression.
- 9. Has any active autoimmune disease or a history of autoimmune disease. 10. Has serious or uncontrolled diseases such as history of chronic heart failure.
- 11. 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.
- 13. Has vaccinated with vaccines or attenuated vaccines within 4 weeks before the first dose.
- 14. Has received surgery, or unhealed wounds within 4 weeks before the first dose.
- 15. Has Hepatic, renal, blood coagulation dysfunction. 16. Has interstitial lung disease or non-infectious pneumonia and present residual lesions.
- 17. Has received systemic treatment for active infection before the first dose.
- 18. Has active or latent tuberculosis. 19. Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus DNA copy number > upper limit of normal.
- 20. Human immunodeficiency virus antibody positive , hepatitis C antibody (HCV-Ab) and hepatitis C virus DNA copy number > upper limit of normal.
- 21. Breastfeeding or pregnant women. 22. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Peking University Third Hospital
Beijin, Beijing Municipality, 100191
Peking Hospital
Beijin, Beijing Municipality, 100730
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100083
First Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Canser Hospital
Changsha, Hunan, 410006
Union Medical College Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, 350000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhejiang Tumor Hospital
Hangzhou, Zhejiang, 310022
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, 150081
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266005
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Shanghai Tumor Hospital
Shanghai, Shanghai Municipality, 200065
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Henan People's Hospital
Zhengzhou, Henan, 450003
About this study
Official title: A Phase II, Multicenter, Open, Single-arm Study of TQB2450 Injection (PD-L1 Antibody) in Subjects With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
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.
- Being tested
- TQB2450
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| TQB2450 | Experimental | TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle. Receives: Drug: TQB2450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Measured: up to 96 weeks
Secondary outcomes (5)
Progression-Free Survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 96 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: up to 96 weeks
Disease Control Rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 24 months
Time to Response (TTR)
TTR defined as time from the first dose to the first assessment of PR or CR.
Measured: up to 24 months
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start6 Aug 2019
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Why it stopped: The population of target indication is small and screening is difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)Studies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002622
- Sponsor's protocol ID
- TQB2450-II-02
- Status last verified
- Jan 2021
- First submitted
- 27 Jun 2019
- Last updated
- 25 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open, Single-arm Study of TQB2450 Injection (PD-L1 Antibody) in Subjects With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
- ClinicalTrials.gov ID
- NCT04002622
- Acronym / sponsor ID
- TQB2450-II-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The population of target indication is small and screening is difficult.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2450 | Experimental | Drug: TQB2450TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Histologically confirmed relapsed or refractory primary mediastinal large B-cell lymphoma.
- 2. 18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy > 3 months.
- 3. At least one measurable lesion. 4. Left ventricular ejection fraction (LVEF) measured by the cardiac echocardiography ≥ 50%.
- 5. Screening laboratory values must meet the following criteria:hemoglobin ≥ 80 g/L; neutrophils ≥ 1.510^9/L; platelets ≥ 100 x 10^9/ L.
- 6. Understood and signed an informed consent form.
Key exclusion criteria (16 listed)
- 1. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
- 2. 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.
- 3. 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.
- 4. Has received emergency cytoreductive surgery to control tumors. 5. Has received allogeneic hematopoietic stem cell transplantation within the last 5 years.
- 6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450TQB2450 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. | Drug | TQB2450 |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 96 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR).
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Disease Control Rate (DCR)
Time frame: up to 24 months
Time to Response (TTR)
Time frame: up to 24 months
Overall Survival (OS)
Time frame: up to 24 months
Results and safety
The study was stopped early (reason given: The population of target indication is small and screening is difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB2450 in people with Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The population of target indication is small and screening is difficult.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.