OncoMatch/Clinical Trials/NCT07009002
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma
Is NCT07009002 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including CAR19TIF cells and Fludarabine for b cell lymphoma.
Treatment: CAR19TIF cells · Fludarabine · Cyclophosphamide — In this single-center, single-arm, prospective, Phase 1/2 study, the safety and efficacy of autologous BCOR and ZC3H12 genes knock-out CD19-targeting chimeric antigen receptor (CAR) T-cell therapy will be evaluated in patients with refractory/relapsed (r/r) B-cell Lymphoma. For simplicity, we have termed these CD19 CAR T cells lacking ZC3H12A and BCOR as CAR19TIF( immortal-like and functional CD19 CAR T ) cells, reflecting their immortal-like and functional characteristics. In phase 1, 3 eligible patients will be enrolled and receive CAR19TIF cells at a initial dose of 5×10\^5 cells/kg. Based on the results, subsequently an additional 3-15 patients will be enrolled in a "3+3" dose-escalation/decline design to adjust the dose of CAR19TIF cells to achieve optimal safety and efficacy. The recommended Phase 2 dose (RP2D) will then be established. 10 to 12 subjects will be enrolled and receive CAR19TIF cells infusion at dose of RP2D.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (detected by immunohistochemistry [IHC])
CD19 positive (detected by immunohistochemistry [IHC])
Allowed: BCL2 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL)
Allowed: BCL6 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL)
Allowed: MYC rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL)
Allowed: CCND1 overexpression
Mantle cell lymphoma (MCL) ... overexpress cyclin D1
Allowed: IGH t(11;14)(q13;q32) translocation
Mantle cell lymphoma (MCL) ... chromosome translocation t(11;14)(q13;q32)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline or bendamustine-containing chemotherapy — MCL
For MCL, prior therapy must have included: Anthracycline or bendamustine-containing chemotherapy
Must have received: anti-CD20 monoclonal antibody — MCL
For MCL, prior therapy must have included: Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative)
Must have received: Bruton's tyrosine kinase inhibitor — MCL
For MCL, prior therapy must have included: Bruton's tyrosine kinase inhibitor (BTKi)
Must have received: anti-CD20 monoclonal antibody — other types
For other types, prior therapy must have included: Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative)
Must have received: anthracycline-containing chemotherapy — other types
For other types, prior therapy must have included: Anthracycline containing chemotherapy regimen
Cannot have received: CD19 targeted therapy
Prior CD19 targeted therapy
Cannot have received: CAR-T therapy or other genetically modified T cell therapy
Prior CAR-T therapy or other genetically modified T cell therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1 x 10^9/L, Platelet count ≥50 x 10^9/ L, hemoglobin (Hgb) ≥ 80g/L (hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions above).
Kidney function
Serum creatinine≤1.5 upper limit of normal (ULN) or creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min.
Liver function
Serum alanine aminotransferase / aspartate aminotransferase (ALT/ AST) ≤ 3 upper limit of normal (ULN); Total bilirubin ≤ 1.5 ULN, except in subjects with Gilbert's syndrome.
Cardiac function
Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings.
Adequate renal, hepatic, pulmonary and cardiac function defined as: ... (see details above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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