B Cell Lymphoma
Conditions
Keywords
CD19, CD22, CAR-T
Brief summary
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma
Detailed description
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.
Interventions
BIOLOGICALCD19 and CD22 targeted prime CAR- T cells
A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
Sponsors
Chongqing Precision Biotech Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent 2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. Evidence for cell membrane CD19 or CD22 expression 4. All genders ages: 2 to 75 years 5. The expect time of survive is above 3 months; 6. KPS\>60 7. No serious mental disorders ; 8. Left ventricular ejection fraction ≥50% 9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN; 10. Sufficient renal function defined by creatinine clearance≤2 x ULN; 11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications; 13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion criteria
1. Previous history of other malignancy; 2. Presence of uncontrolled active infection; 3. Evidence of disorder that need the treatment by glucocorticoids; 4. Active or chronic GVHD 5. The patients treatment by inhibitor of T cell 6. Pregnant or breasting-feeding women; 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events that related to treatment | 2 years | Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) |
| The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma | 6 months | The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of prime CAR copies in bone marrow | 2 years | Determine the quantity of prime CAR copies in bone marrow by qPCR |
| Quantity of prime CAR copies in peripheral blood | 2 years | Determine the quantity of prime CAR copies in peripheral blood by qPCR |
| Rate of CD19 and CD22 positive cells in Bone marrow | 1 years | Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry |
| Levels of IL-6 in Serum | 3 months | Serological determination of IL-6 |
| Levels of IL-10 in Serum | 3 months | Serological determination of IL-10 |
| Rate of prime CAR-T cells in bone marrow | 2 years | Determine the rate of prime CAR-T cells in bone marrow by means of flow cytometry |
| Levels of CRP in Serum | 3 months | Serological determination of CRP |
| Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma | 2 years | DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored) |
| Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma | 2 years | PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored) |
| Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma | 2 years | OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored) |
| Levels of TNF-α in Serum | 3 months | Serological determination of TNF-α |
| Rate of prime CAR-T cells in peripheral blood | 2 years | Determine the rate of prime CAR-T cells in peripheral blood by means of flow cytometry |
Countries
China
Contacts
Primary ContactZhi Yang, PhD
Backup ContactSanbin Wang, MD
Outcome results
None listed