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

NCT03800706 | Unknown Phase 2 DMC

• 1 other identifier: TQB2450-II-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety and Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complete Response (CR)

  Up to 96 weeks

Study Arms (1)

TQB2450

EXPERIMENTAL

Drug: TQB2450

Interventions

TQB2450 DRUG

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.

TQB2450

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 、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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

No.17, panjiayuan nanli, chaoyang district, Beijing

Beijing, 100021, China

RECRUITING

Central Study Contacts

Yuan Kai Shi

CONTACT

13701251865; 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: January 9, 2019
• First Posted: January 11, 2019
• Study Start: March 25, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-10

Locations

CN (1)