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Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264039
Recruitment Status : Unknown
Verified February 2020 by Xi Zhang, MD, Xinqiao Hospital of Chongqing.
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
Gracell Biotechnology Shanghai Co., Ltd.
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
The Second Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital Of Guizhou Medical University
Central South University
The First Affiliated Hospital of Kunming Medical College
The General Hospital of Western Theater Command
Second Affiliated Hospital of Xi'an Jiaotong University
Nanfang Hospital of Southern Medical University
Fujian Medical University Union Hospital
The First Affiliated Hospital of Anhui Medical University
Tang-Du Hospital
Information provided by (Responsible Party):
Xi Zhang, MD, Xinqiao Hospital of Chongqing

Brief Summary:
The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia B-cell Lymphoma Biological: anti-CD19 UCAR-T cells Drug: Fludarabine Drug: Cytoxan Drug: Melphalan Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022


Arm Intervention/treatment
Experimental: 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
Biological: 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

Drug: Fludarabine
30mg/m^2 per day for 6 days

Drug: Cytoxan
300mg/m^2 per day for 2 to 6 days determined by tumor burden at baseline

Drug: Melphalan
50 to 70 mg/m^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline




Primary Outcome Measures :
  1. the anti-tumor efficiency of anti-CD19 UCAR-T cells [ Time Frame: 4 weeks after infusion ]
    ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value


Secondary Outcome Measures :
  1. the long-term efficiency of anti-CD19 UCAR-T cells [ Time Frame: 3 and 6 months after infusion ]
    ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value



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Ages Eligible for Study:   2 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Diagnosis of recurrent B-cell acute lymphoblastic leukemia (B-ALL), B-cell acute lymphoblastic lymphoma (B-LLy), or B-non-Hodgkin lymphoma (B-NHL)

    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:

  1. Pregnant or lactating.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264039


Contacts
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Contact: Xi Zhang, MD +8613808310064 ext +8613808310064 zhangxxi@sina.com
Contact: Ruihao Huang +86 18984398751 1169731117@qq.com

Locations
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China, Chongqing
Department of Hematology, Xinqiao Hospital
ChongQing, Chongqing, China, 400037
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
Gracell Biotechnology Shanghai Co., Ltd.
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
The Second Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital Of Guizhou Medical University
Central South University
The First Affiliated Hospital of Kunming Medical College
The General Hospital of Western Theater Command
Second Affiliated Hospital of Xi'an Jiaotong University
Nanfang Hospital of Southern Medical University
Fujian Medical University Union Hospital
The First Affiliated Hospital of Anhui Medical University
Tang-Du Hospital
Investigators
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Principal Investigator: Xi Zhang, MD Xinqiao Hospital of Chongqing
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Responsible Party: Xi Zhang, MD, Chef of Hematology Department, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT04264039    
Other Study ID Numbers: antiCD19-UCAR-T
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Neoplasms
Neoplasms
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Fludarabine
Cyclophosphamide
Melphalan
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists