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

NCT04781634 | Recruiting Phase 1

• 1 other identifier: PBC025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

B-ALL

Keywords

CD19; CD22; CAR-T

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Rate of prime CAR-T cells in bone marrow

  2 years

• Rate of prime CAR-T cells in peripheral blood

  2 years

• Quantity of prime CAR copies in bone marrow

  2 years

• Quantity of prime CAR copies in peripheral blood

  2 years

• Rate of CD19 and CD22 positive cells in Bone marrow

  1 years

Study Arms (1)

prime CAR- T cells

EXPERIMENTAL

Patients will be be treated with CD19 and CD22 prime CAR- T cells

Biological: CD19 and CD22 targeted prime CAR-T cells

Interventions

CD19 and CD22 targeted prime CAR-T cells BIOLOGICAL

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

prime CAR- T cells

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
• Failed to standard chemotherapy regimens;
• Relapse after complete remission, high-risk and / or refractory patients ;
• Relapse after hematopoietic stem cell transplantation;
• 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)
• Evidence for cell membrane CD19 or CD22 expression
• All genders ages: 2 to 75 years
• The expect time of survive is above 3 months;
• KPS\>60
• No serious mental disorders ;
• Left ventricular ejection fraction ≥50%
• Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
• Sufficient renal function defined by creatinine clearance≤2 x ULN;
• Sufficient pulmonary function defined by indoor oxygen saturation≥92%;

You may not qualify if:

• Previous history of other malignancy;
• Presence of uncontrolled active infection;
• Evidence of disorder that need the treatment by glucocorticoids;
• Active or chronic GVHD
• The patients treatment by inhibitor of T cell
• Pregnant or breasting-feeding women;
• 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.

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Interventions

Antigens, CD19

Intervention Hierarchy (Ancestors)

Antigens, CD; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Antigens, Differentiation, B-Lymphocyte; Minor Histocompatibility Antigens; Histocompatibility Antigens; Isoantigens; Biomarkers

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093; yangzhi@precision-biotech.com

Sanbin Wang, MD

CONTACT

Sanbin1011@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 4, 2021
• Study Start: March 7, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

CN (1)