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| Name | Class |
|---|---|
| Ganzhou City People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT719 Injection treatment group | Experimental | GT719 Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT719 Injection | Biological | GT719 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Incidence and severity of Adverse events (AEs) occurring after infusion and their proportion | 28 days |
| Proportion of participants experiencing dose limiting toxicity | Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | 3 months overall response rate (ORR) | 3 months |
| Best Overall Response(BOR) | 3 months Best Overall Response(BOR) |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral white blood cell count | The measured total count of white blood cells in peripheral blood | From the time of infusion up to Month 3 |
| Changes in peripheral white blood cell differential | The dynamic changes in the quantity and proportion of various types of white blood cells in peripheral blood over time |
Inclusion Criteria:
1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
2. Aged 18 to 75 years (inclusive), regardless of gender.
3. Participants with refractory or relapsed acute B-cell lymphoblastic leukemia or B-cell lymphoma diagnosed according to the WHO 2016 classification.
4. CD19 positivity confirmed by flow cytometry and/or histopathology.
5. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
6. Expected survival period > 12 weeks;
7. For any prior systemic therapy (excluding immune checkpoint inhibitors), at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed before the participant is scheduled to receive the study treatment. For any prior treatment with immune checkpoint inhibitors (such as anti-PD-1 or anti-PD-L1 monoclonal antibodies like Pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), at least 3 half-lives or 28 days (whichever is shorter) must have passed before the participant is scheduled to receive the study treatment.
8. Toxicities caused by prior treatments must be stable and resolved to grade ≤ 1, excluding clinically insignificant toxicities such as alopecia.
9. Have adequate renal, hepatic, pulmonary, and cardiac functions, defined as follows:
10. Female participants of childbearing potential must have a negative result from a serum or urine pregnancy test. Females who have undergone surgical sterilization or been postmenopausal for at least 2 years are not considered to be of childbearing potential. They must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment, and are strictly prohibited from donating oocytes within 1 year after the infusion of the study treatment during the study period.
11. Male participants who have active sexual life with females of childbearing potential must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment. All male participants are strictly prohibited from donating sperm within 1 year after the infusion of the study treatment during the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongsheng Zhou | Contact | 086-18665730280 | hanson_tcm@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganzhou City People's Hospital | Recruiting | Ganzhou | Jiangxi | China |
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| 3 months |
| Duration of Response(DOR) | 3 months Duration of Response(DOR) | 3 months |
| Progression-Free Survival(PFS) | 3 months Progression-Free Survival(PFS) | 3 months |
| Overall Survival(OS) | 3 months Overall Survival(OS) | 3 months |
| Time to Maximum Expansion of Infused Cells (Tmax) | The time point at which the concentration of infused cells in peripheral blood reaches the peak level following product infusion, measured by flow cytometry | From the time of infusion up to Month 3 |
| Peak Expansion Level of Infused Cells (Cmax) | The maximum copy number or cell count of infused cells in peripheral blood after infusion, measured by flow cytometry | From the time of infusion up to Month 3 |
| Area Under the Curve of Infused Cells (AUC) | The area under the concentration-time curve of infused cells in peripheral blood from the time of infusion to the evaluation endpoint, reflecting the total exposure of cells in vivo | From the time of infusion up to Month 3 |
| In Vivo Survival Time of Infused Cells | The duration during which infused cells remain detectable in peripheral blood, defined as the time point when the cell concentration drops to the lower limit of detection | From the time of infusion up to Month 12 |
| From the time of infusion up to Month 3 |
| Phenotypic changes of GT719 cells and other NKT cells | Detect the dynamic changes in cell surface marker expression, morphological characteristics and function-related phenotypic features of GT719 cells and other natural killer T (NKT) cells | From the time of infusion up to Month 3 |
| Changes in inflammatory factors in peripheral blood over different treatment time periods | Dynamically monitor the concentration fluctuations of various inflammatory factors in peripheral blood during different treatment time periods | From the time of infusion up to Month 3 |
| Anti-Drug Antibody (ADA) Testing | Positive rate of detectable anti-CAR antibodies in serum at each time point | From the time of infusion up to Month 3 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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