Status:
UNKNOWN
Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for CD19-positive ALL
Lead Sponsor:
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborating Sponsors:
Hrain Biotechnology Co., Ltd.
First Affiliated Hospital of Wenzhou Medical University
Conditions:
CD19-positive ALL
Eligibility:
All Genders
13-70 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.
Detailed Description
Primary Objectives 1\. To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia. Secondary Objectives 1. To determi...
Eligibility Criteria
Inclusion
- 13 Years to 70 Years, Male and female;
- Expected survival \> 12 weeks;
- Clinical performance status of ECOG score 0-2;
- Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions:
- Patients received at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
- Disease recurrence after stem cell transplantation.
- Accessible to intravenous injection, and no white blood cell collection contraindications
- Patients who meet the following conditions:
- Creatinine \< 2.5 mmol/l;
- Cardiac ejection fraction\>50%, no pericardial effusion and no pleural effusion (ECHO examination);
- Baseline oxygen saturation\>92%;
- Total bilirubin≤1.5xULN;
- ALT/AST≤2.5x normal.
- Able to understand and sign the Informed Consent Document.
Exclusion
- Accompanied by other malignant tumor
- Active hepatitis B, hepatitis C, syphilis, HIV infection
- Suffering severe cardiovascular or respiratory disease
- Any other diseases could affect the outcome of this trial
- Any affairs could affect the safety of the subjects or outcome of this trial
- Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment
- Occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment
- Patients who are accounted by researchers to be not appropriate for this test
- Received CAR-T treatment or other gene therapies before assignment
- Patients with symptoms of central nervous system
- Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04303520
Start Date
May 3 2018
End Date
February 1 2021
Last Update
March 11 2020
Active Locations (1)
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1
Henan Province of TCM
Zhengzhou, Henan, China