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

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

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

Study Overview

• Status: Recruiting
• Conditions: B-ALL
• Intervention / Treatment: Biological: CD19 and CD22 targeted prime CAR-T cells

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhi Yang, PhD; Phone Number: 86-13206140093; Email: yangzhi@precision-biotech.com
• Study Contact Backup: Name: Sanbin Wang, MD; Email: Sanbin1011@163.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • 920th Hospital of Joint Logistics Support Force
      • Contact: Sanbin Wang, MD
      • Contact: Sanbin Wang, MD; Email: Sanbin1011@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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-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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): March 7, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: CAR-T; CD19; CD22
• Other Study ID Numbers: PBC025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No