- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03101709
The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a study for the patients with B cell lymphoma. Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects.
The purpose of this study is to assess ssess the safety and feasibility of CART-19 cells in the patients with relapsed and refractory CD19+ B cell lymphoma.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Yongping Song
- Email: ph200811@163.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China
- Recruiting
- Henan Cancer Hospital
-
Contact:
- Yongping Song
- Phone Number: -86-13521186987
- Email: ph200811@163.com
-
Contact:
- Yongping Song
-
Principal Investigator:
- Yongping Song, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years to 70 years, expected survival > 3 months;
- CD19 positive B-cell lymphoma;
- KPS >80;
- Having at least one measurable lesions;
- Cardiac function: 1-2 levels; Liver: TBIL≤3ULN,AST ≤2.5ULN,ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L);
- No serious allergic constitution;
- No other serous diseases that conflicts with the clinical program;
- No other cancer history;
- No serious mental disorder;
- Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B or hepatitis C infection;
- Recent or current use of glucocorticoid or other immunosuppressor;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Transaminase >2.5ULN, Bilirubin >3ULN,Creatinine>1.25ULN
- Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;
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: CART-19
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells.
The CART-19 cells are to be administered on day0,day1,day2.
|
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day
IV for 2 days(Day-5 to day-4).
Fludarabine 25 mg/m2/day IV for 3 days (Day-5 to day-3).
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety as assessed by the occurence of study related adverse events
Time Frame: 6 months
|
monitor the occurence of study related adverse events
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
efficacy assessed by anti-tumor activity of CART-19 cells
Time Frame: 2 years
|
anti-tumor activity of CART-19 cells will be determined in a follow-on study
|
2 years
|
duration of CART-19
Time Frame: 2 years
|
Determine duration of in vivo survival of CART-19 cells
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Yongping Song, Henan Cancer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
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
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- 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
- Fludarabine
Other Study ID Numbers
- HenanCH109
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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