- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04264039
Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies
Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Xi Zhang, MD
- Phone Number: +8613808310064 +8613808310064
- Email: zhangxxi@sina.com
Study Contact Backup
- Name: Ruihao Huang
- Phone Number: +86 18984398751
- Email: 1169731117@qq.com
Study Locations
-
-
Chongqing
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ChongQing, Chongqing, China, 400037
- Department of Hematology, Xinqiao Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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4 weeks after infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 and 6 months after infusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Xi Zhang, MD, Xinqiao Hospital of Chongqing
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Leukemia, Lymphoid
- Leukemia
- Hematologic Neoplasms
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Melphalan
- Fludarabine
Other Study ID Numbers
- antiCD19-UCAR-T
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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