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/PHASE2
60 participants
INTERVENTIONAL
2016-08-30
2018-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IM19 CART
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of IM19CART cells administered intravenously.
IM19 CAR-T
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
Interventions
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IM19 CAR-T
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
* Less than 1 year between last chemotherapy and progression
* Not eligible or appropriate for allo-HSCT
* To be aged 4 to 65 years
* Estimated survival of ≥ 6 months, but ≤ 2 years
* ECOG score ≤2
* Relapse after auto-HSCT
* Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
* Voluntary participation in the clinical trials and sign the informed consent.
Exclusion Criteria
* Patients have GVHD, which needs treatment with immunosuppressive agents
* Patients with prolonged QT interval or severe heart disease
* Patients in pregnancy or breast-feeding period
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
* ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl
* Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
* HIV infection
* Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
4 Years
65 Years
ALL
No
Sponsors
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Beijing Immunochina Medical Science & Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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hui liu, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Locations
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Beijing hospital
Beijing, , China
Peking University People's Hospital (PKUPH)
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaojun Huang, MD
Role: primary
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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