A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

Study Overview
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Brief Summary
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Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma

Official Title
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A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

Conditions
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Safety and Effectiveness

Intervention / Treatment
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* Drug: TQB2450


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has voluntarily agreed to participate by giving written informed consent.; Histopathological confirmed classical Hodgkin's lymphoma; Relapsed/refractory cHL include：a)subject with relapse and progression after salvage chemotherapy followed by autologous stem cell transplantation(ASCT); b) subject with no ASCT: The first-line chemotherapy must be systemic multi-drug combination chemotherapy and subsequent chemotherapy requires at least one first-line chemotherapy must be systemic multi-drug combination chemotherapy; subject which is refractory didn't achieve PR after 2 cycles or didn't achieve CR after Age ranged from 18 to 75 years; At least one measurable disease ; Patients must have ECOG performance status of 0-2; Subject must have adequate organ functions ：Count of Blood Cells:hemoglobin content(HB)≥80g/L; absolute neutrophil count (ANC) ≥ 1.0 × 10^9 / L; platelet count (PLT) ≥ 75 × 10^9 / L;; Biochemical examination: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), with the exception of patients with hepatic metastases and Gilbert's syndrome(TBIL≤3×ULN） ; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN，with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) , serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance rate（CCR）≥50 mL/min；Serum amylase and lipase ≤ 1.5 x ULN Blood coagulation function:International standardized ratio(INR)≤1.5×ULN、Activation partial thrombin time(APTT)≤1.5×ULN、Prothrombin time≤1.5×ULN；Doppler ultrasound evaluation：Left ventricular ejection fraction（LVEF)≥50%×MLN; Exclusion Criteria: 1、Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma； 2、 Prior exposure to any anti-PD-1, anti-PD-L1 ， anti-CTLA-4 antibody or CAR-T cell treatment(Any other antibody that has been applied to a T cell synergistic stimulus or checkpoint pathway); 3、Need to therapy with other anticancer during the study; 4、Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQB2450<br> | Drug: TQB2450<br>* TQB2450 is injectived (IV) every-3-weeks (Q3W) and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent, the longest use time of experimental drugs is 96 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate(ORR) | Overall Response Rate (ORR) defined as the proportion of subjects who achieves a best response of CR or PR, assessed by IRC per the Lugano Classification | Up to 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response (CR) | Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis). | Up to 96 weeks |