OncoMatch/Clinical Trials/NCT06829771
Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma
Is NCT06829771 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including TQB2825 and TQB2825 for diffuse large b cell lymphoma.
Treatment: TQB2825 · TQB2825 — To explore the efficacy and safety of TQB2825 injection combined immunochemotherapy in subjects with untreated or R/R DLBCL. The efficacy evaluation indicators are objective response rate (ORR), complete response rate (CR rate),progression free survival (PFS), duration of response (DOR) and overall survival(OS). The safety evaluation indicators are dose-limiting toxicity (DLT) , maximum tolerated dose (MTD)and recommended phase II dose (RP2D).
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 positive
Immunophenotypic analysis shows that the tumor is CD20 positive
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: corticosteroid — pre-treatment allowed for R-CHOP cohort
allowing for corticosteroid pre-treatment (with or without vincristine) or non-curative palliative local radiotherapy
Must have received: CD20 monoclonal antibody — at least one line required for GemOx cohort
patients with diffuse large B-cell lymphoma who have received at least one line of systemic treatment (including at least one line with CD20 monoclonal antibody) and are not suitable for hematopoietic stem cell transplantation or have failed treatment after transplantation or relapsed, and whose disease progressed during the most recent treatment or relapsed after completion of treatment or confirmed no objective response after adequate treatment
Cannot have received: R-GemOx or GemOx
Previously received R-GemOx or GemOx treatment
Cannot have received: antibody drugs targeting both CD3 and CD20
Previously used other antibody drugs targeting both CD3 and CD20
Cannot have received: CAR-T cell therapy
Received Chimeric antigen receptor T (CAR-T) treatment or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first dose
Cannot have received: autologous hematopoietic stem cell transplantation
Received Chimeric antigen receptor T (CAR-T) treatment or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first dose
Cannot have received: chemotherapy, immunotherapy, monoclonal antibody
Received chemotherapy, immunotherapy, monoclonal antibody treatment within 4 weeks before the first dose
Cannot have received: radiotherapy or small molecule targeted drugs
radiotherapy or small molecule targeted drugs within 2 weeks, or still within the 5 half-lives of the drug
Cannot have received: traditional Chinese medicine with anti-tumor indications (Compound Eschar Capsules, Kangai Injection, Kanglaite Capsules/Injection, Aidi Injection, Yanzaizi Oil Injection/Capsules, Xiaocaiping Tablets/Injection, Huachansu Capsules)
Received traditional Chinese medicine (including Compound Eschar Capsules, Kangai Injection, Kanglaite Capsules/Injection, Aidi Injection, Yanzaizi Oil Injection/Capsules, Xiaocaiping Tablets/Injection, Huachansu Capsules, etc.) with anti-tumor indications approved by the National Medical Products Administration (NMPA) in the drug instructions within 2 weeks before the first dose
Cannot have received: other anti-tumor clinical trial drugs
Participated in and used other anti-tumor clinical trial drugs within 4 weeks or 5 half-lives before the first dose
Lab requirements
Blood counts
Hemoglobin (HGB) ≥80g/L; Absolute neutrophil count (NEUT) ≥1.0×10^9/L; Platelet count (PLT) ≥ 75×10^9/L (if bone marrow invasion, platelets ≥50×10^9/L)
Kidney function
Serum creatinine (CR) ≤ 1.5x ULN or estimated glomerular filtration rate ≥50 ml/min by Cockcroft-Gault formula
Liver function
Total bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN with liver metastasis)
Laboratory tests meet the following criteria (not corrected with blood transfusion or hematopoietic growth factors within 14 days before screening): 1. Hemoglobin (HGB) ≥80g/L; 2. Absolute neutrophil count (NEUT) ≥1.0×10^9/L; 3. Platelet count (PLT) ≥ 75×10^9/L (if accompanied by bone marrow invasion, platelets ≥50×10^9/L). 4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If accompanied by liver metastasis, then ALT and AST ≤ 5 ULN; 6. Serum creatinine (CR) ≤ 1.5 ULN or estimated glomerular filtration rate ≥50 ml/min by the Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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