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CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03118180
Recruitment Status : Unknown
Verified April 2017 by He Huang, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Innovative Cellular Therapeutics Co., Ltd.
Information provided by (Responsible Party):
He Huang, Zhejiang University

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date April 18, 2017
Actual Study Start Date  ICMJE April 5, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
overall response rate [ Time Frame: Up to 30 months ]
the number of response patients/the number of total patients
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma
Official Title  ICMJE The Safety and Efficacy Evaluation of CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma
Brief Summary A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.
Detailed Description A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma. Complete remission rate, overall survival rate, relapse rate and CRS rate were monitored. CART associated toxicities were also monitored.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Biological: CD19 targeted chimeric antigen receptor T cells
CD19 targeted chimeric antigen receptor T cells for refractory and relapsed B cell lymphoma
Study Arms  ICMJE Experimental: CART19 group
All patients were included for CART19 therapy
Intervention: Biological: CD19 targeted chimeric antigen receptor T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed aggressive B cell lymphoma
  2. Chemotherapy-refractory disease, defined as one or more of the following:

    No response to first-line therapy (primary refractory disease); PD as best response to first-line therapy SD as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R- CHOP) with SD duration no longer than 6 months from last dose of therapy OR No response to second or greater lines of therapy PD as best response to most recent therapy regimen SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy OR Refractory post-ASCT Disease progression or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy

  3. Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)
  4. Age 18 or older
  5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  6. ANC ≥1000/uL
  7. Platelet count ≥75,000/uL
  8. Absolute lymphocyte count ≥100/uL
  9. Adequate renal, hepatic, pulmonary and cardiac function defined as:

    Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min Serum ALT/AST ≤2.5 ULN Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome. Cardiac ejection fraction ≥ 50% ,no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings No clinically significant pleural effusion Baseline oxygen saturation >92% on room air

  10. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

Exclusion Criteria:

  1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
  2. History of Richter's transformation of CLL
  3. Autologous stem cell transplant within 6 weeks of planned CAR-C19 infusion
  4. History of allogeneic stem cell transplantation
  5. Prior CD19 targeted therapy with the exception of subjects who received CAR-C19 in this study and are eligible for re-treatment
  6. Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
  7. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
  8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the K Medical Monitor.
  9. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti- HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
  10. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
  11. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
  12. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  13. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
  14. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
  15. Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
  16. Primary immunodeficiency
  17. History of deep vein thrombosis or pulmonary embolism within 6 months of enrollment
  18. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
  19. History of severe immediate hypersensitivity reaction to any of the agents used in this study
  20. Live vaccine ≤ 6 weeks prior to start of conditioning regimen
  21. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
  22. Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of CAR-C19
  23. In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
  24. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118180
Other Study ID Numbers  ICMJE CART19-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party He Huang, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE Innovative Cellular Therapeutics Co., Ltd.
Investigators  ICMJE
Principal Investigator: He Huang, Dr Zhejiang University
PRS Account Zhejiang University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP