Clinical trial · Interventional
A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma
NCT03800706CI-TRIAL-00047619unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Safety and Effectiveness | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB2450 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB2450
- interventionNames
- Drug: TQB2450
Primary outcomes (1)
- measure
- Overall Response Rate(ORR)
- timeFrame
- Up to 96 weeks
- description
- 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
Secondary outcomes (1)
- measure
- Complete Response (CR)
- timeFrame
- Up to 96 weeks
- description
- Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.