a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: prime CAR- T cells Patients will be be treated with CD19 and CD22 prime CAR- T cells |
Biological: CD19 and CD22 targeted prime CAR- T cells
A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- Levels of TNF-α in Serum [3 months]
Serological determination of TNF-α
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed written informed consent
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Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
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Failed to standard chemotherapy regimens;
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Relapse after complete remission, high-risk and / or refractory patients ;
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Relapse after hematopoietic stem cell transplantation;
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Evidence for cell membrane CD19 or CD22 expression
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All genders ages: 2 to 75 years
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The expect time of survive is above 3 months;
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KPS>60
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No serious mental disorders ;
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Left ventricular ejection fraction ≥50%
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Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
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Sufficient renal function defined by creatinine clearance≤2 x ULN;
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Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
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With single or venous blood collection standards, and no other cell collection contraindications;
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Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
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Previous history of other malignancy;
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Presence of uncontrolled active infection;
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Evidence of disorder that need the treatment by glucocorticoids;
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Active or chronic GVHD
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The patients treatment by inhibitor of T cell
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Pregnant or breasting-feeding women;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 920th Hospital of Joint Logistics Support Force | Kunming | Yunnnan | China |
Sponsors and Collaborators
- Chongqing Precision Biotech Co., Ltd
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PBC026