Actively Recruiting
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
Led by Grit Biotechnology · Updated on 2025-12-30
34
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
G
Grit Biotechnology
Lead Sponsor
G
Ganzhou City People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enrolled, signed informed consent, and able to follow the study protocol
- Aged 18 to 75 years, any gender
- Diagnosed with refractory or relapsed acute B-cell lymphoblastic leukemia or B-cell lymphoma per WHO 2016 classification
- CD19 positivity confirmed by flow cytometry or histopathology
- Eastern Collaborative Oncology Group (ECOG) physical status score of 0 or 1
- Expected survival longer than 12 weeks
- At least 2 weeks or 5 half-lives since prior systemic therapy (except immune checkpoint inhibitors), or 3 half-lives or 28 days since immune checkpoint inhibitors
- Prior treatment toxicities stable and resolved to grade 1 or less, excluding alopecia
- Adequate kidney, liver, lung, and heart function by specified laboratory and clinical measures
- Female participants of childbearing potential with a negative pregnancy test and agreement to use contraception for 1 year after treatment; sterilized or postmenopausal females exempt
- Male participants with active sexual life with females of childbearing potential must use contraception for 1 year after treatment and agree not to donate sperm for 1 year
You will not qualify if you...
- History or evidence of central nervous system (CNS) leukemia/lymphoma or brain metastases
- History or active testicular leukemia/lymphoma
- Other untreated malignant tumors within 5 years, except certain treated cancers
- Hematopoietic stem cell transplant within 6 weeks or less than 6 months since allogeneic transplant
- History of CD19 CAR-T/NK therapy except prior GT719 eligible for retreatment
- Use of systemic glucocorticoids within 7 days before cell infusion, except inhaled
- Allergic reactions to study drugs or components
- Uncontrolled or suspected infections requiring IV antibiotics
- Positive tests for HIV, syphilis, CMV IgM, or EBV IgM
- Active hepatitis B or C; stable HBV carriers may be included
- Presence of indwelling lines or drainage catheters except central venous catheters
- History of CNS disorders such as seizures or dementia
- Lymphoma involving heart chambers
- Recent serious heart, lung, or vascular conditions within 6 months
- Expected urgent tumor treatment within 6 weeks
- Primary immunodeficiency
- Recent symptomatic blood clots requiring anticoagulants
- Any condition interfering with safety or efficacy assessment
- Recent live or mRNA vaccination within 8 weeks or inactivated vaccines within 4 weeks prior to conditioning
- Pregnant or breastfeeding females of childbearing potential
- Unwillingness to use contraception during study and 6 months after treatment
- Unlikely to complete study visits or comply with participation
- Autoimmune diseases causing organ damage or requiring immunosuppressants in past 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ganzhou City People's Hospital
Ganzhou, Jiangxi, China
Actively Recruiting
Research Team
H
Hongsheng Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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