OncoMatch/Clinical Trials/NCT07008885
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL
Is NCT07008885 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including CAR19TIF cells and Fludarabine for acute lymphocytic leukemia.
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 acute lymphoblastic leukaemia (B-ALL). In phase 1, 3 eligible patients will be enrolled and receive BCOR and ZC3H12 genes knock-out CD19 CAR T cell therapy 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 BCOR and ZC3H12 genes knock-out CD19 CAR T 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 BCOR and ZC3H12 genes knock-out CD19 CAR T cell infusion at dose of RP2D.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (positive)
CD19+ B-ALL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard chemotherapy — induction
Refractory disease is defined by not achieving an initial complete response (CR) after 2 cycles of a standard chemotherapy regimen (primary refractory). Subjects who were refractory to subsequent chemotherapy regimens after an initial remission were considered chemorefractory.
Cannot have received: CD19 targeted therapy
Prior CD19 targeted therapy
Cannot have received: CAR-T cell therapy
Prior CAR-T therapy or other genetically modified T cell therapy
Cannot have received: radioimmunotherapy
Exception: except prophylaxis of CNS involvement
Radioimmunotherapy, radiotherapy, within 8 weeks (except prophylaxis of CNS involvement) before Inclusion
Cannot have received: anti-leukemic therapy
Use of previous anti-leukemic therapy within 5 half-lives prior to CAR19TIF cells administration
Lab requirements
Blood counts
Coagulation Function: International Normalized Ratio (INR) ≤ 1.5 ×ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN
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×ULN; Total bilirubin ≤ 1.5×ULN
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: Serum creatinine≤1.5 upper limit of normal (ULN) or creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min. Serum alanine aminotransferase / aspartate aminotransferase (ALT/AST) ≤ 3×ULN; Total bilirubin ≤ 1.5×ULN. Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings. Coagulation Function: International Normalized Ratio (INR) ≤ 1.5 ×ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN. Baseline oxygen saturation >91% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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