Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
Clinical Study of Chimeric Mesothelin Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies
1 other identifier
interventional
20
1 country
1
Brief Summary
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedOctober 20, 2015
October 1, 2015
2.1 years
October 19, 2015
October 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of Study related adverse events
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical
Until week 24
Secondary Outcomes (1)
Anti-tumor responses to CART-meso cell infusions
up to 24 weeks
Other Outcomes (1)
In vivo existence of CART-meso
1 year
Study Arms (1)
anti-meso CAR T cells
EXPERIMENTALDose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Patients receive anti-meso-CAR retroviral vector-transduced autologous-derived T cells on days 0, 1, 2 in the absence of disease progression or unacceptable toxicity.
Interventions
genetically engineered lymphocyte therapy
Eligibility Criteria
You may qualify if:
- Chemotherapy refractory or relapsed mesothelin positive malignant mesothelioma,ovarian tumors,pancreatic cancer,triple negative breast cancer,endometrial cancer and other mesothelin positive tumor
- Patients must be 18 years of age or older.
- Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
- Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
- Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
- Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m.
- Seronegative for HIV antibody.
- Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
- Patients must be willing to practice birth control during and for four months following treatment. NOTE: women of child-bearing age must have evidence of negative pregnancy test.
- Patients must be willing to sign an informed consent.
You may not qualify if:
- Patients with life expectancy less than 12 months will be excluded.
- Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- Pregnant and/or lactating women will be excluded.
- Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
- Patients with any type of primary immunodeficiencies will be excluded from the study.
- Patients requiring corticosteroids (other than inhaled) will be excluded.
- Patients with history of T cell tumors will be excluded.
- Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 20, 2015
Study Start
October 1, 2015
Primary Completion
November 1, 2017
Study Completion
November 1, 2018
Last Updated
October 20, 2015
Record last verified: 2015-10