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

Phase 1

Recruiting

• Conditions: B-ALL
• Interventions: Biological: CD19 and CD22 targeted prime CAR-T cells

• Registration Number: NCT04781634
• Lead Sponsor: Chongqing Precision Biotech Co., Ltd

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 -ALL

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

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Study Start: 2021-03-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-12-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prime CAR- T cells	CD19 and CD22 targeted prime CAR-T cells	Patients will be be treated with CD19 and CD22 prime CAR- T cells

Primary Outcome Measures

Name	Time	Method
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-ALL	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

Name	Time	Method
Rate of prime CAR-T cells in bone marrow	2 years	Determine the rate of prime CAR-T cells in bone marrow by 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 flow cytometry
Quantity of prime CAR copies in bone marrow	2 years	Determine the quantity of prime CAR copies in bone marrow by qPCR
Levels of TNF-α in Serum	3 months	Serological determination of TNF-α
Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL	2 years	OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)
Quantity of prime CAR copies in peripheral blood	2 years	Determine the quantity of prime CAR copies in peripheral blood by qPCR
Levels of IL-6 in Serum	3 months	Serological determination of IL-6
Levels of CRP in Serum	3 months	Serological determination of CRP
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-10 in Serum	3 months	Serological determination of IL-10
Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL	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-ALL	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)

Trial Locations

Locations (1)

920th Hospital of Joint Logistics Support Force; 🇨🇳 Kunming, Yunnan, China