Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies
NCT ID: NCT04264039
Last Updated: 2020-02-11
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
EARLY_PHASE1
30 participants
INTERVENTIONAL
2020-04-01
2022-04-01
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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anti-CD19 UCAR-T cells
After preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD19 UCAR-T cells between 1 and 5 ×10\^7 cells/Kg will be evaluated
anti-CD19 UCAR-T cells
Dose range:1 to 5 ×10\^7 cells/Kg, Dose level one: 1×10\^7 cells/Kg, Dose level two: 3×10\^7 cells/Kg, Dose level three:5 ×10\^7 cells/Kg
Fludarabine
30mg/m\^2 per day for 6 days
Cytoxan
300mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline
Melphalan
50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline
Interventions
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anti-CD19 UCAR-T cells
Dose range:1 to 5 ×10\^7 cells/Kg, Dose level one: 1×10\^7 cells/Kg, Dose level two: 3×10\^7 cells/Kg, Dose level three:5 ×10\^7 cells/Kg
Fludarabine
30mg/m\^2 per day for 6 days
Cytoxan
300mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline
Melphalan
50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline
Eligibility Criteria
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Inclusion Criteria
2\. CD19-positive tumor (≥20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue)）
3\. Hgb ≥ 7.0 (can be transfused)
4\. Life expectancy greater than 12 weeks
5\. Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.
Exclusion Criteria
2. Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).
3. Active infection with HIV or HTLV.
4. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6.
5. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\<30% or LVEF(left ventricular ejection fraction)\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment).
6. CNS abnormalities: Presence of CNS(central nervous system)-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF(cerebrospinal fluid) with ≥ 5 WBC( white blood cell)s per mm3 (unless negative by the Steinherz/Bleyer algorithm); Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
2 Years
70 Years
ALL
No
Sponsors
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Gracell Biotechnologies (Shanghai) Co., Ltd.
INDUSTRY
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Central South University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
The General Hospital of Western Theater Command
OTHER
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Fujian Medical University Union Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Tang-Du Hospital
OTHER
Xinqiao Hospital of Chongqing
OTHER
Responsible Party
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Xi Zhang, MD
Chef of Hematology Department
Principal Investigators
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Xi Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Xinqiao Hospital of Chongqing
Locations
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Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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antiCD19-UCAR-T
Identifier Type: -
Identifier Source: org_study_id
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