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

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ClinicalTrials.gov Identifier: NCT03155425
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This is an open-label, multicenter, non-randomized, phase2 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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma, Adult Drug: SHR-1210 Phase 2

Detailed Description:
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The secondary objective is to observe the duration of response,progression free survival,time to response,overall survival and safety of SHR-1210 in relapsed or refractory classic Hodgkin's lymphoma.Pharmacokinetic index is also investigated in 12 patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Classic Hodgkin's Lymphoma
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Injection SHR-1210
SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes.
Drug: SHR-1210
A humanized monoclonal immunoglobulin




Primary Outcome Measures :
  1. ORR assess by IRC [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
    rate of subjects achieved complete response plus partial response in all evaluable subjects



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed classic Hodgkin's lymphoma ;
  2. 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.
  3. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
  4. ECOG performance status of 0 or 1;
  5. Life expectancy ≥ 12 weeks.;
  6. Adequate laboratory parameters during the screening period as evidenced by the following:

    1. Absolute neutrophil count ≥ 1.0 × 109/L ;
    2. Platelets ≥ 75 × 109/L;
    3. Hemoglobin ≥ 8.0 g/dL;
    4. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN
    5. Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
    6. Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
  7. 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 7days before entering the group and not in in lactation; 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.
  8. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

1. Known nodular lymphoma predominant Hodgkin lymphoma or Grey zone lymphoma. 2. Known central nervous system lymphoma. 3. 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 > 20mg. 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. . live vaccine within 4 weeks before the first dose SHR-1210.Inactivated vaccines against seasonal influenza is allowed.Live attenuated influenza vaccines were not approved for intranasal administration.

4. laboratory test

  1. . known HIV positive or known AIDS.
  2. . Untreated active hepatitis; Hepatitis B and hepatitis C infection in common. 5. 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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155425


Contacts
Contact: Yu Yao, MD 021-50118402-135 yaoyu@shhrp.com
Contact: Chenglei Qiao, MD 18036618600 qiaochenglei@hrs.com.cn

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Zhu, MD    (+8610)88196596    Zj@bjcancer.org   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Study Director: Yu Yao, MD Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03155425     History of Changes
Other Study ID Numbers: SHR-1210-II-204
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs