Status:
UNKNOWN
a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Lead Sponsor:
Chongqing Precision Biotech Co., Ltd
Conditions:
B Cell Lymphoma
Eligibility:
All Genders
2-75 years
Phase:
PHASE1
PHASE2
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 Cell Lymphoma
Detailed Description
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T c...
Eligibility Criteria
Inclusion
- 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 collection contraindications;
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion
- 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.
Key Trial Info
Start Date :
May 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04782193
Start Date
May 23 2021
End Date
July 1 2024
Last Update
April 18 2023
Active Locations (1)
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1
920th Hospital of Joint Logistics Support Force
Kunming, Yunnnan, China