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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07131254 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation, CD19 CAR-T/NK therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positivity is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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