Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
NCT ID: NCT02580747
Last Updated: 2015-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2015-10-31
2018-11-30
Brief Summary
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PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
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Detailed Description
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II. Determine duration of in vivo survival of CART-meso cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-meso TCR (T-cell receptor) zeta:CD137 over time.
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-tumor response due to CART-meso cell infusions.
II. Estimate relative trafficking of CART-meso cells to tumor in bone marrow and lymph nodes.
III. For patients with stored or accessible tumor cells determine tumor cell killing by CART-meso cells in vitro.
IV. Determine if cellular or humoral host immunity develops against the murine anti-meso, and assess correlation with loss of detectable CART-meso (loss of engraftment).
V. Determine the relative subsets of CART-meso T cells (Tcm, Tem, and Treg).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anti-meso CAR T cells
Dose 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.
anti-meso-CAR vector transduced T cells
genetically engineered lymphocyte therapy
Interventions
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anti-meso-CAR vector transduced T cells
genetically engineered lymphocyte therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must be 18 years of age or older.
3. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
4. 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.
5. Seronegative for HIV antibody.
6. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
7. 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.
8. Patients must be willing to sign an informed consent.
Exclusion Criteria
2. 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.
3. 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.
4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
5. Pregnant and/or lactating women will be excluded.
6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
7. Patients with any type of primary immunodeficiencies will be excluded from the study.
8. Patients requiring corticosteroids (other than inhaled) will be excluded.
9. Patients with history of T cell tumors will be excluded.
10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
18 Years
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Han weidong
PI
Locations
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Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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s2015-080-06
Identifier Type: -
Identifier Source: org_study_id
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