- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030001
PD-1 Antibody Expressing CAR T Cells for Mesothelin Positive Advanced Malignancies
January 20, 2017 updated by: Ningbo Cancer Hospital
PD-1 Antibody Expressing Chimeric Antigen Receptor T Cells for Mesothelin Positive Advanced Malignancies
This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or refractory malignant tumors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huajun Jin, PhD
- Phone Number: 86-13162257545
- Email: hj_jin@126.com
Study Locations
-
-
Zhejiang
-
Ningbo, Zhejiang, China
- Recruiting
- Ningbo No.5 Hospital (Ningbo Cancer Hospital)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1. Relapsed or refractory advanced solid malignancies.
- 2. Progressive disease and no response to current therapy.
- 3. Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred. And patients are willing to attend the clinical trial.
- 4. Gender unlimited, age from 18 years to 80 years.
- 5. Life expectancy≥6 months.
- 6. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
- 7. Adequate venous access for apheresis, and no other contraindications for leukapheresis ; Peripheral venous access ;no contraindication of lymphocyte separation.
- 8. IHC( immuno-histochemistry) result of tumor tissue: mesothelin positive for :frequency≥2,intensity≥2 +. The percentage of tumor cell nuclei stained (0, no staining; 1, ≤10%; 2, 10-50% and 3, >50%) and the staining intensity (ranging from 0 to 3+).
- 9. Adequate hepatic function, renal function and bone marrow function:WBC≥3.0×109/L,PLT≥60×109/L,HGB≥85g/L,LY≥0.7×109/L; Alanine aminotransferase/Aspartate transaminase(ALT/AST) 2.5 times the upper limit of the normal value, total bilirubin(TBiL) 1times the upper limit of the normal value, Serum creatinine1.5 times the upper limit of the normal value.
- 10. Willing and able to understand and sign the Informed Consent Document.
- 11. Women of child-bearing age must have evidence of negative pregnancy test. Patients must be willing to practice birth control during and for four months following treatment.
Exclusion Criteria:
- 1. Life expectancy6 months.
- 2. Patients with uncontrolled active infection will be excluded.
- 3. Patients with severe heart and lung dysfunction; uncontrolled hypertension, 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; aberrant pulmonary function testing: with a forced expiratory volume (FEV) of <30%(predicted), diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) <30% and oxyhemoglobin saturation90% will be excluded.
- 4. Patients with severe liver and kidney dysfunction or chronic diseases of important organs will be excluded.
- 5. Patients with active autoimmune disease requiring immunosuppressive therapy will be excluded.
- 6. Patients requiring corticosteroids (other than inhaled) will be excluded.
- 7. Patients with other severe diseases or situations improper for the research will be excluded, including neurologic disease, mental disease, immune disease, metabolic disease, and contagious disease.
- 8. Pregnant and/or lactating women will be excluded.
- 9. Patients who have had other bio-therapy in the past 4 weeks.
- 10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
- 11. Patients with the subject suffering disease affects the understanding of informed consent or complying with study protocol will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: PD-1 antibody expressing CAR-T cells
PD-1 antibody expressing mesothelin specific CAR-T cells
|
Patients will receive an IV infusion of PD-1 antibody expressing mesothelin specific CAR engineered peripheral blood leukocyte.
On day 21, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of infusion of autologous mesothelin specific CAR T cells
Time Frame: 2 years
|
Safety of infusion of autologous mesothelin specific CAR T cells with PD-1 antibody expressing in patients with relapsed or refractory advanced solid malignancies using the NCI CTCAE V4.0 criteria
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 2 years
|
2 years
|
|
progression free survival
Time Frame: 1 year
|
1 year
|
|
the response evaluation criteria of solid tumor
Time Frame: 2 years
|
Defined as the overall response rate (ORR), the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on the response evaluation criteria in solid tumor version 1.1 (RECIST1.1).
|
2 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of life quality after treatment
Time Frame: 2 years
|
2 years
|
proliferation and persistence of mesothelin specific CAR T cells in patients after treatment
Time Frame: 6 months
|
6 months
|
expression of PD-1 antibody in patients after treatment
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Qijun Qian, PhD, Shanghai Cell Therapy Engineering Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 15, 2017
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
February 1, 2019
Study Registration Dates
First Submitted
January 20, 2017
First Submitted That Met QC Criteria
January 20, 2017
First Posted (Estimate)
January 24, 2017
Study Record Updates
Last Update Posted (Estimate)
January 24, 2017
Last Update Submitted That Met QC Criteria
January 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2017-01-P01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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