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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04781634
Other study ID # PBC025
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 7, 2021
Est. completion date July 1, 2024

Study information

Verified date February 2023
Source Chongqing Precision Biotech Co., Ltd
Contact Zhi Yang, PhD
Phone 86-13206140093
Email yangzhi@precision-biotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 -ALL


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-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 75 Years
Eligibility 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. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients) 4. Evidence for cell membrane CD19 or CD22 expression 5. All genders ages: 2 to 75 years 6. The expect time of survive is above 3 months; 7. KPS>60 8. No serious mental disorders ; 9. Left ventricular ejection fraction =50% 10. Sufficient hepatic function defined by ALT/AST=3 x ULN and bilirubin=2 x ULN; 11. Sufficient renal function defined by creatinine clearance=2 x ULN; 12. Sufficient pulmonary function defined by indoor oxygen saturation=92%; 13. With single or venous blood collection standards, and no other cell collection contraindications; 14. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CD19 and CD22 targeted prime CAR-T cells
A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously

Locations

Country Name City State
China 920th Hospital of Joint Logistics Support Force Kunming Yunnan

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Precision Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL 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
Secondary Rate of prime CAR-T cells in bone marrow Determine the rate of prime CAR-T cells in bone marrow by flow cytometry 2 years
Secondary Rate of prime CAR-T cells in peripheral blood Determine the rate of prime CAR-T cells in peripheral blood by flow cytometry 2 years
Secondary Quantity of prime CAR copies in bone marrow Determine the quantity of prime CAR copies in bone marrow by qPCR 2 years
Secondary Quantity of prime CAR copies in peripheral blood Determine the quantity of prime CAR copies in peripheral blood by qPCR 2 years
Secondary 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
Secondary Levels of IL-6 in Serum Serological determination of IL-6 3 months
Secondary Levels of IL-10 in Serum Serological determination of IL-10 3 months
Secondary Levels of TNF-a in Serum Serological determination of TNF-a 3 months
Secondary Levels of CRP in Serum Serological determination of CRP 3 months
Secondary Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL 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
Secondary Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B-ALL 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
Secondary Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored) 2 years
See also
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Active, not recruiting NCT03751709 - Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL Phase 1
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