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| Name | Class |
|---|---|
| Anhui Provincial Hospital | OTHER_GOV |
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This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
A single arm open-label clinical study is designed to prelinarily determine the safety, efficacy, the ratio of CD19-positive cells in peripheral blood and cell kinetics after administration of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell hematolymphatic malignancies. All subjects will receive UTAA09 cells infusion.
Primary objective: explore the preliminary safety and efficacy of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell line hematolymphatic malignancies.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UTAA09 cells for infusion | Experimental | Off-the-shelf γδT cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day-7~Day-2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UTAA09 cells for infusion | Biological | Intravenous injection, dosage:1-10×10^8 CAR+ γδT cells, Cell concentration: 2×10^7 cells/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety after UTAA09 injection treatment | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | About 2 years |
| Evaluation of the efficacy after UTAA09 injection treatment | 3-month total response rate (ORR) which includes CR, CRi, and PR will be assessed. | About 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacokinetic (about Cmax) | Assessment of the peak Plasma Concentration (Cmax) of UTAA09 cells amplified in peripheral blood after administration. | About 2 years |
| Assessment of pharmacokinetic (about Tmax) |
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Inclusion Criteria:
Patients aged between 3~70 (including cut-off values), regardless of gender and race;
Expected survival time>12 weeks;
ECOG score 0-2;
CD19-positive relapsed/refractory B-cell hematolymphatic malignancies;
Liver and kidney function, cardiopulmonary function meet the following requirements:
Be able to understand the trial and have signed the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingbing Wang, MD | Contact | 13856007984 | wangxingbing@ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xingbing Wang, MD | The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC (AnHui Provincial Hospital) | Recruiting | Hefei | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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UTAA09 injection
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| Fludarabine | Drug | 30 mg/m^2/day×4 days |
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| Cyclophosphamide | Drug | 1000 mg/m^2/day×3 days |
|
Assessment of the time to reach the highest concentration (Tmax) of UTAA09 cells amplified in peripheral blood after administration.
| About 2 years |
| Assessment of pharmacokinetic (about AUC0-28d) | Assessment of the Area under the plasma concentration versus time curve (AUC) for 28 days after UTAA09 cells administration. | About 2 years |
| Assessment of pharmacokinetic (about AUC0-90d) | Assessment of the Area under the plasma concentration versus time curve (AUC) for 90 days after UTAA09 cells administration. | About 2 years |
| Evaluation of Pharmacodynamic | To determine the depletion of peripheral blood CD19-positive B cells at each time point, the concentration of CAR-γδT-associated serum cytokine (CRP, IL-6, etc.). | About 2 years |
| To evaluate the efficacy (Overall Survival) | Defined as the time from the start of UTAA09 injection therapy to patient death (due to any cause). | About 2 years |
| To evaluate the efficacy (Duration Of Response) | Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause). | About 2 years |
| To evaluate the efficacy (Progression Free Survival) | Defined as the time from the start of UTAA09 injection therapy to the first disease progression or recurrence or death due to any cause. | About 2 years |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |