OncoMatch/Clinical Trials/NCT07131254
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors
Is NCT07131254 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies GT719 for hematological malignancy (leukemia- lymphoma).
Treatment: GT719 — This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 34 subjects will be enrolled in this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 positivity
CD19 positivity confirmed by flow cytometry and/or histopathology.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: hematopoietic stem cell transplantation
Exception: performed within 6 weeks prior to the planned infusion of GT719 cells
Hematopoietic stem cell transplantation with curative intent performed within 6 weeks prior to the planned infusion of GT719 cells
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: ≤6 months have elapsed since they received allogeneic hematopoietic stem cell transplantation
≤6 months have elapsed since they received allogeneic hematopoietic stem cell transplantation
Cannot have received: CD19 CAR-T/NK therapy
Exception: except for participants who have received GT719 and are eligible for retreatment
History of CD19 CAR-T/NK therapy (except for participants who have received GT719 and are eligible for retreatment)
Lab requirements
Kidney function
Creatinine Clearance (Cockcroft-Gault) ≥ 60 mL/min
Liver function
ALT/AST ≤ 2.5x ULN; total bilirubin ≤ 1.5 mg/dl (excluding Gilbert syndrome)
Cardiac function
Ejection fraction ≥ 50%, no signs of pericardial effusion by ECHO, no clinically significant ECG abnormalities
adequate renal, hepatic, pulmonary, and cardiac functions, defined as: Creatinine Clearance (Cockcroft-Gault) ≥ 60 mL/min; ALT/AST ≤ 2.5x ULN; total bilirubin ≤ 1.5 mg/dl, excluding Gilbert syndrome; cardiac ejection fraction ≥ 50%, no signs of pericardial effusion detected by ECHO, and no clinically significant abnormalities found on ECG; no clinically significant pleural effusion; baseline oxygen saturation > 92% when measured under room air conditions.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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