Status:
UNKNOWN
Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL
Lead Sponsor:
Beijing Doing Biomedical Co., Ltd.
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, re...
Detailed Description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-c...
Eligibility Criteria
Inclusion
- Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
- KPS\>60.
- Life expectancy\>3 months.
- Gender unlimited, age from 18 years to 70 years.
- CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
- Patients who have failed at least one line of a standard treatment.
- No serious mental disorder.
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- No other tumors.
- Patients volunteer to participate in the research.
- Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.
Exclusion
- KPS\<50.
- Patients are allergic to cytokines.
- Central nervous system leukemia within 28 days.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
- Pregnancy and nursing females.
- HIV/HBV/HCV Infection.
- Other situations we think improper for the research.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03271515
Start Date
March 1 2021
End Date
March 1 2023
Last Update
January 20 2021
Active Locations (1)
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1
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China, 065200