Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL
NCT ID: NCT02656147
Last Updated: 2017-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2017-10-31
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: 1
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.
Anti-CD19-CAR γδT
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
Experimental: 2
Chronic lymphoblastic leukemia with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.
Anti-CD19-CAR γδT
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
Experimental: 3
Non-hodgkin lymphoma treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.
Anti-CD19-CAR γδT
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
Interventions
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Anti-CD19-CAR γδT
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
Eligibility Criteria
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Inclusion Criteria
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 70 years.
5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. 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).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. 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 infusion.
Exclusion Criteria
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
18 Years
70 Years
ALL
No
Sponsors
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Beijing Doing Biomedical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Li gangyi, master
Role: STUDY_CHAIR
Beijing Doing Biomedical Co., Ltd.
Locations
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Beijing DOING Biomedical Co., Ltd
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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Doing-004
Identifier Type: -
Identifier Source: org_study_id
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