Last updated: April 16, 2023
Sponsor: Chongqing Precision Biotech Co., Ltd
Overall Status: Active - Recruiting
Phase
1/2
Condition
Lymphoma
Lymphoma, B-cell
Treatment
N/AClinical Study ID
NCT04782193
PBC026
Ages 2-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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;
- 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 collectioncontraindications;
- Ability and willingness to adhere to the study visit schedule and all protocolrequirements.
Exclusion
Exclusion Criteria:
- 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.
Study Design
Total Participants: 40
Study Start date:
May 23, 2021
Estimated Completion Date:
July 01, 2024
Study Description
Connect with a study center
920th Hospital of Joint Logistics Support Force
Kunming, Yunnnan
ChinaActive - Recruiting
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