Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
Conditions
Brief summary
The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.
Detailed description
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
Interventions
BIOLOGICALUTAA09 injection
The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108\ 1 x 1010 CD19-CAR - γδT cells.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
UTAA09 injection
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntarily participate in clinical studies; 2. ECOG score 0-1 points; 3. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and inert lymphoma transformed into diffuse large B-cell lymphoma; CD19 and/or CD20 positivity; 4. At least one measurable tumor lesion determined according to Lugano's criteria: the longest diameter of intranodal lesions\>1.5cm, and the longest diameter of extranodal lesions\>1.0cm.
Exclusion criteria
1. Received other chimeric antigen receptor therapy or gene modified cell therapy before screening; 2. Subjects who were undergoing systemic steroid therapy during screening and were determined by the researchers to require long-term use of systemic steroid therapy during the treatment period (excluding inhalation or local use); 3. Any unstable heart disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III), and severe arrhythmia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of dose limiting toxicity (DLT ) | 28 days after infusion | The incidence, severity, and types of dose limiting toxicity |
| The incidence of TEAEs | 28 days after infusion | The incidence, severity, and types of adverse events that occur during treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 24 months after infusion | Evaluate the overall response rate based on the efficacy criteria of Lugano 2014 |
| PFS | 24 months after infusion | Evaluate the progression free survival based on the efficacy criteria of Lugano 2014 |
| OS | 24 months after infusion | Evaluate the overall survival based on the efficacy criteria of Lugano 2014 |
Countries
China
Contacts
Primary ContactLei Fan, Doctor
Outcome results
None listed