Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies
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|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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
30mg/m^2 per day for 6 days
300mg/m^2 per day for 2 to 6 days determined by tumor burden at baseline
50 to 70 mg/m^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline
- 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
- 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|
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.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).
- Active infection with HIV or HTLV.
- Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6.
- 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).
- 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.
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
|Contact: Xi Zhang, MD||+8613808310064 ext +firstname.lastname@example.org|
|Contact: Ruihao Huang||+86 email@example.com|
|Department of Hematology, Xinqiao Hospital|
|ChongQing, Chongqing, China, 400037|
|Principal Investigator:||Xi Zhang, MD||Xinqiao Hospital of Chongqing|
|Responsible Party:||Xi Zhang, MD, Chef of Hematology Department, Xinqiao Hospital of Chongqing|
|Other Study ID Numbers:||
|First Posted:||February 11, 2020 Key Record Dates|
|Last Update Posted:||February 11, 2020|
|Last Verified:||February 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating