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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prime CAR- T cells | Experimental | Patients will be be treated with CD19 and CD22 prime CAR- T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 and CD22 targeted prime CAR- T cells | Biological | A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events that related to treatment | 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) | 2 years |
| The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma | The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of prime CAR-T cells in bone marrow | Determine the rate of prime CAR-T cells in bone marrow by means of flow cytometry | 2 years |
| Rate of prime CAR-T cells in peripheral blood | Determine the rate of prime CAR-T cells in peripheral blood by means of flow cytometry |
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Inclusion Criteria:
Signed written informed consent
Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
Evidence for cell membrane CD19 or CD22 expression
All genders ages: 2 to 75 years
The expect time of survive is above 3 months;
KPS>60
No serious mental disorders ;
Left ventricular ejection fraction ≥50%
Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
Sufficient renal function defined by creatinine clearance≤2 x ULN;
Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
With single or venous blood collection standards, and no other cell collection contraindications;
Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Yang, PhD | Contact | 86-13206140093 | yangzhi@precision-biotech.com | |
| Sanbin Wang, MD | Contact | Sanbin1011@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Sanbin Wang, MD | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Principal Investigator |
| Cheng Qian, PhD | Chongqing University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force | Recruiting | Kunming | Yunnnan | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018941 | Antigens, CD19 |
| ID | Term |
|---|---|
| D015703 | Antigens, CD |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
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| 2 years |
| Quantity of prime CAR copies in bone marrow | Determine the quantity of prime CAR copies in bone marrow by qPCR | 2 years |
| Quantity of prime CAR copies in peripheral blood | Determine the quantity of prime CAR copies in peripheral blood by qPCR | 2 years |
| Rate of CD19 and CD22 positive cells in Bone marrow | Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry | 1 years |
| Levels of IL-6 in Serum | Serological determination of IL-6 | 3 months |
| Levels of IL-10 in Serum | Serological determination of IL-10 | 3 months |
| Levels of TNF-α in Serum | Serological determination of TNF-α | 3 months |
| Levels of CRP in Serum | Serological determination of CRP | 3 months |
| Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma | 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) | 2 years |
| Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma | PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored) | 2 years |
| Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma | OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored) | 2 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001685 |
| Biological Factors |
| D000944 | Antigens, Differentiation, B-Lymphocyte |
| D015778 | Minor Histocompatibility Antigens |
| D006649 | Histocompatibility Antigens |
| D007519 | Isoantigens |
| D015415 | Biomarkers |