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

NCT04600947 | Unknown Phase 2

• 1 other identifier: LP002-II-PMBL-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

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

  up to approximately 24 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  up to approximately 24 months

• Duration of Response (DOR)

  up to approximately 24 months

• Time to Response (TTR)

  up to approximately 24 months

• Disease Control Rate (DCR)

  up to approximately 24 months

• Overall survival (OS)

  up to approximately 24 months

Study Arms (1)

LP002

EXPERIMENTAL

Participants will receive LP002 10 mg/kg by intravenous (IV) infusion every 2 weeks (Q2W) for up to 24 months.

Drug: LP002

Interventions

LP002 DRUG

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

LP002

Eligibility Criteria

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

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Taizhou HoudeAoke Biomedical Co., Ltd.: lead

Study Sites (7)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100029, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

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

Guangzhou, Guangdong, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Wuhan University People's Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Study Officials

• Yuankai Shi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, MD

CONTACT

010-87676061; syuankai@cicams.ac.cn

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: October 19, 2020
• First Posted: October 23, 2020
• Study Start: December 30, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2023
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

CN (7)