PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma

NCT03155425 | Completed Phase 2 Results

• 1 other identifier: SHR-1210-II-204
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, multicenter, non-randomized, phase 2 trial to evaluate efficacy and safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma.

Conditions

Hodgkin Lymphoma, Adult

Outcome Measures

Primary Outcomes (1)

• ORR Assess by IRC

  rate of subjects achieved complete response plus partial response in all evaluable subjects (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR)

  CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. ORR of 36 weeks based on CT and PET were reported.

Secondary Outcomes (5)

• DoR Assess by IRC

  CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. DoR of 36 weeks based on CT and PET were reported.

• PFS Assess by IRC

  Up to 3 years

• TTR Assess by IRC

  CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25.

• OS

  Up to 3 years

• Incidence and Severity of Adverse Events (AE)

  Up to 3 years

Study Arms (1)

Injection SHR-1210

EXPERIMENTAL

SHR-1210 injection, 200 mg/dose, intravenous infusion.

Drug: SHR-1210

Interventions

SHR-1210 DRUG

A humanized monoclonal immunoglobulin

Injection SHR-1210

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed classic Hodgkin's lymphoma;
• Relapsed or refractory cHL and meet any of the following criterions: a) did not achieve remission or progression after autologous hematopoietic stem cell transplantation. b) at least 2 lines of systemic chemotherapy and are not suitable for autologous stem cell transplantation;
• Subjects enrolled have measurable lesion (s) according to Lugano 2014 criteria;
• ECOG performance status of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Adequate laboratory parameters during the screening period as evidenced by the following:
• Absolute neutrophil count ≥ 1.0 × 109/L;
• Platelets ≥ 75 × 109/L;
• Hemoglobin ≥ 8.0 g/dL;
• Total bilirubin (TBIL) \< 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN;
• Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
• Coagulation function index: INR ≤1.5×ULN，APTT≤1.5×ULN;
• Women of childbearing potential (WOCBP) must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7 days before entering the group; male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment;
• Able to understand and sign an informed consent form (ICF).

You may not qualify if:

• Known nodular lymphoma predominant Hodgkin lymphoma or Grey zone lymphoma.
• Known central nervous system lymphoma.
• History and complication:
• (1) Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted; (2) Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids \> 10mg; doses \> 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group; (3) Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose SHR-1210; (4) Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody; (5) Participating in other clinical studies or less than 4 weeks before the end of a clinical trial; (6) Known and highly Suspicion of interstitial pneumonia; (7) Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded); (8) Received chemotherapy, radiotherapy, immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1; (9) Prior allo-HSCT; (10) ASCT within 90 days; (11) Impact of major surgery or severe trauma had been eliminated for less than 14 days; (12) Active pulmonary tuberculosis; (13) Severe acute or chronic infection requiring systemic therapy; (14) Suffering from heart failure (New York Heart Association standard III and given appropriate medical treatment. Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months; (15) Inoculated with live vaccine within 4 weeks before receiving the investigational drug. Injections of inactivated influenza vaccine for seasonal influenza are permitted, but not live attenuated influenza vaccines for intranasal use.
• \. laboratory test:
• (1) known HIV positive or known AIDS; (2) Untreated active hepatitis; co-infection with hepatitis B and hepatitis C.
• \. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• Song Y, Wu J, Chen X, Lin T, Cao J, Liu Y, Zhao Y, Jin J, Huang H, Hu J, Luo J, Zhang L, Xue H, Zhang Q, Wang W, Chen C, Feng J, Zhu J. A Single-Arm, Multicenter, Phase II Study of Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma. Clin Cancer Res. 2019 Dec 15;25(24):7363-7369. doi: 10.1158/1078-0432.CCR-19-1680. Epub 2019 Aug 16.

  PMID: 31420358 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Clinical Operation Director: Chenglei Qiao
• Organization: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

chenglei.qiao@hengrui.com

+86-18036618600

Study Officials

• Zhenyu Xiao, MD

  Jiangsu Hengrui Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: May 15, 2017
• First Posted: May 16, 2017
• Study Start: June 9, 2017
• Primary Completion: August 31, 2020
• Study Completion: September 30, 2020
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2023-04

Locations

CN (2)