a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

B-ALL Clinical Trial

Official title:

Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B-ALL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781634
• Other study ID #: PBC025
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• B-ALL

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