RecruitingPhase 1Phase 2NCT04781634

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

Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

40 participants

Start Date

Mar 7, 2021

Study Type

INTERVENTIONAL

Conditions

B-ALL

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

Eligibility

Min Age: 2 YearsMax Age: 75 Years

Inclusion Criteria17

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%;
With single or venous blood collection standards, and no other cell collection contraindications;
Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria7

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.