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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Safety and Effectiveness

Treatments: Drug: TQB2450

Study type: Interventional

Funder types: Industry

Identifiers

NCT03800706

TQB2450-II-01

Details and patient eligibility

About

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

Enrollment: 85 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has voluntarily agreed to participate by giving written informed consent.;
2. Histopathological confirmed classical Hodgkin's lymphoma;
3. 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
4. Age ranged from 18 to 75 years;
5. At least one measurable disease ;
6. Patients must have ECOG performance status of 0-2;
7. 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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

TQB2450

Experimental group

Treatment:

Drug: TQB2450