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

Recruiting now · Phase 1/Phase 2

Conditions studied: B-ALL

In brief

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

Key facts

Study ID

NCT04781634

Run by

Chongqing Precision Biotech Co., Ltd

People needed

40

Starts

2021-03-07

Expected to finish

2027-07-01

Last updated by the study team

2025-02-25

Who can join

Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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%;
• 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.

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.

Where it is running

• 920th Hospital of Joint Logistics Support Force — Kunming, Yunnan, China (enrolling)

Full record on ClinicalTrials.gov

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