Last updated: April 16, 2023
Sponsor: Chongqing Precision Biotech Co., Ltd
Overall Status: Active - Recruiting
Phase
1/2
Condition
Lymphoma
Chronic Lymphocytic Leukemia
Leukemia
Treatment
N/AClinical Study ID
NCT04649983
PBC012
Ages 2-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed written informed consent
- Diagnose as Relapsed and Refractory B Cell Leukemia and Lymphoma, and meet one of thefollowing 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 havereceived a standard induction chemotherapy regimen and who have not achieved completeremission after TKI treatment or have relapsed after remission (cannot tolerate TKItreatment or have contraindications to TKI treatment or the presence of TKI class)Except for drug resistant patients);
- Evidence for cell membrane CD19 and 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:
September 01, 2019
Estimated Completion Date:
July 01, 2024
Study Description
Connect with a study center
920th Hospital of Joint Logistics Support Force
Kunming, Yunnan
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.