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Primary Mediastinal Large B-Cell Lymphoma (PMBCL)Phase 2NCT04600947

Study of LP002 for the Treatment of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

A Phase 2 study testing LP002 in people with Primary Mediastinal Large B-Cell Lymphoma (PMBCL), run by Taizhou HoudeAoke Biomedical Co., Ltd. at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

LP002 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 years and older
What is being tested?
LP002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
7 sitesChina
Study dates
30 Dec 2020to 30 May 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the trial;
  • Age ≥ 18 years old, male or female;
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score;
  • Life expectancy ≥ 3 months;
  • Subjects must have histopathological diagnosis of primary mediastinal large B-cell lymphoma (PMBCL), according to the WHO classification of lymphoma (revised in 2017) (diagnosis is confirmed by the central pathological review), and meet the following criteria:
  • Recurrence after autologous hematopoietic stem cell transplantation (ASCT), or complete remission (CR) or partial remission (PR) is not achieved within 60 days after ASCT. If patients with relapse or refractory ASCT receive other interventions, they must be relapsed or refractory after the last systemic treatment;
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  • Patients who are not suitable for ASCT must be second-line or above chemotherapy invalid or recurring; local radiotherapy alone is not considered as first-line treatment;
  • Need to be treated with rituximab, or cannot be treated with rituximab for any reason;
  • According to the Lugano standard in 2014, CT/MRI should show that there is at least one measurable tumor lesion in two vertical directions, with the length of the intranodal lesion ≥1.5cm and the length of the extranodal lesion ≥1.0cm;
  • The subject has sufficient organ and bone marrow function to meet the following laboratory examination standards:
  • Blood routine: absolute neutrophil count (ANC)≥1.0×10^9/L; platelet count (PLT)≥80×10^9/L; hemoglobin (HGB)≥8.0 g/dL; Note: It is not allowed to use any blood components, cell growth factors and other interventions within 14 days before the examination.
  • Liver function: Patients without liver metastases require serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN. Patients with liver metastases require: TBIL≤1.5×ULN; ALT and AST≤5×ULN;
  • Renal function: Serum creatinine (Scr) ≤1.5×ULN, or endogenous creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
  • The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 times ULN;
  • Reproductive men and women of childbearing age are willing to take effective contraceptive measures from signing the informed consent form to 6 months after the last administration of the trial drug. Women of childbearing age must have a negative blood pregnancy test within 7 days before the first trial drug administration.

Who cannot join

  • Suffered from other malignant tumors in the past 3 years (except skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have been effectively controlled);
  • Currently participating in interventional clinical research treatment, or receiving other experimental drugs or using experimental device treatment within 4 weeks before the first administration;
  • Received systemic systemic chemotherapy or targeted drug therapy within 4 weeks or 5 half-lives before the first administration;
  • The study drug has received anti-tumor indications Chinese herbal medicine, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc., except for local use to control pleural effusion or pericardial effusion) within 2 weeks before the first administration Systemic systemic therapy;
  • Received monoclonal antibody drug treatment within 4 weeks before the first administration;
  • Received radical or palliative radiotherapy within 4 weeks before the first administration;
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  • Received autologous stem cell transplantation within 8 weeks before the first administration;
  • Prior to the first administration of the study drug, there was a grade > 1 toxicity (excluding hair loss, non-clinical) caused by previous anti-tumor treatments;
  • Previously used anti-PD-1, anti-PD-L1, anti-programmed cell death protein ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs or acted on T cell co-stimulation Or any other drugs in the checkpoint pathway;
  • Have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks before the first administration of the study drug, excluding:
  • Nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie ≤10mg/day prednisone or its equivalent dose of other glucocorticoids);
  • Short-term use of glucocorticoids as a preventive medication for allergic reactions (such as prevention of contrast agent allergy);
  • Short-term use of glucocorticoids to treat non-autoimmune diseases (such as delayed type hypersensitivity caused by contact allergens);
  • Has central nervous system (CNS) invasion, including brain parenchyma, meningeal invasion, or spinal cord compression;
  • A history of active and known autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc., except: Type I Diabetes, hypothyroidism that can be controlled only by hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), controlled celiac disease, or diseases that are not expected to recur without external stimuli;
  • Has a history of or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases;
  • Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy, including tuberculosis, syphilis (TP-Ab positive), AIDS (HIV antibody positive), etc.;
  • Known history of human immunodeficiency virus (HIV) infection; acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load ≥200 IU/mL or ≥10^3 copies/mL); acute or chronic active Hepatitis C (HCV antibody positive and HCV RNA positive);
  • Within 4 weeks before the first administration of the study drug or plan to receive live vaccines or live attenuated vaccines during the study period;
  • Has received a major surgical operation within 4 weeks before the first treatment with the study drug or is expected to undergo major surgery during the study treatment;
  • Known to be allergic to recombinant humanized PD-L1 monoclonal antibody or any of its excipients; Known to have a history of allergic diseases or have severe allergies;
  • Cardiovascular diseases meet any of the following: congestive heart failure with heart function ≥ NYHA II; severe arrhythmia requiring medical treatment; acute myocardial infarction, severe or unstable angina pectoris occurred within 6 months before the first administration, coronary or peripheral artery bypass, stenting; left ventricular ejection fraction (LVEF) <50%; corrected QTcF interval> 450 milliseconds for men and> 470 milliseconds for women, or there is a risk of torsade de pointes ventricular tachycardia factors such as clinically significant hypokalemia, family history of long QT syndrome, or family history of arrhythmia (such as pre-excitation syndrome) as judged by the investigator; hypertension that cannot be effectively controlled (defined as standardized antihypertensive drugs after treatment, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure >90 mmHg);
  • Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage;
  • Combined with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc.;
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  • According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

7 sites in 1 country.

Yuankai Shi, MD contact

010-87676061

syuankai@cicams.ac.cn

7 sites in 1 country

China7 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100029

    Yuankai Shi, MD

  • Hunan Cancer Hospital

    Changsha, Hunan

    Hui Zhou, MD

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Wenyu Li

  • Sun Yat-Sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Yudan Wu, MD

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

    Zhiming Li, MD

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Ying Pang, MD

  • Wuhan University People's Hospital

    Wuhan, Hubei

    Weiping Tao, MD

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Single-arm Phase II Study of LP002 in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

LP002 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. In this study, the efficacy and safety of LP002 for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma will be evaluated.

Being tested
LP002

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP002Drug

    10 mg/kg administered as IV infusion on Day 1 of each 14-day cycle.

Study groups in NCT04600947
Study groupRoleWhat they receive
LP002ExperimentalParticipants will receive LP002 10 mg/kg by intravenous (IV) infusion every 2 weeks (Q2W) for up to 24 months.
Receives: Drug: LP002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

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

    Measured: up to approximately 24 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason. For subjects whose progression or death is unknown, PFS will be censored at the time of the last valid evaluation.

    Measured: up to approximately 24 months

  2. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the time from the first evidence of repsonse (PR or CR) to the first evidence of PD or the date of death for any reason in patients who have been confirmed to have response (2014 Lugano criteria, PR or CR).

    Measured: up to approximately 24 months

  3. Time to Response (TTR)

    Time to Response (TTR) refers to the time from the first treatment with the study drug to the first CR or PR on tumor evaluation.

    Measured: up to approximately 24 months

  4. Disease Control Rate (DCR)

    Disease Control Rate (DCR) refers to the proportion of subjects who achieve CR, PR and SD through imaging evaluation.

    Measured: up to approximately 24 months

  5. Overall survival (OS)

    Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause. For subjects who have not been followed up to death, OS will be censored at the last effective survival follow-up time.

    Measured: up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start30 Dec 2020 (estimated)
  3. Primary completion30 May 2022 (estimated)
  4. Study completion30 May 2023 (estimated)

Resources

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
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04600947
Sponsor's protocol ID
LP002-II-PMBL-01
Status last verified
Oct 2020
First submitted
19 Oct 2020
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LP002 in people with Primary Mediastinal Large B-Cell Lymphoma (PMBCL), run by Taizhou HoudeAoke Biomedical Co., Ltd. at 7 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 15 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuankai Shi, MD (010-87676061, syuankai@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600947.

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 23 Oct 2020.

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