- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03535246
Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells
Tumor Associated Antigen-specific Engineered Immune Effector Cells (EIE) Against Cancer
Study Overview
Detailed Description
Malignant tumor is still a major challenge in medicine and requires technology breakthrough, and its mortality rate is the highest among all diseases. World Health Organization and the American Cancer Association expect about 12 million new cancer patients worldwide each year, with about 8 million cancer deaths (20 thousand cancer deaths per day). At present, more than 20 million people are suffering from cancer, and this figure will increase to 75 million in 2030. In Asia, the incidence of cancer is expected to rise by 60% in 2020, and the number of cancer related deaths will reach 7 million annually in 2030. The incidence of lung, Intestine, breast, prostate and gastric cancer is high, and lung, Intestine, breast and liver cancer are the main causes of cancer related deaths in Asia.
Adoptive immunotherapy based on cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. In vitro induction of tumor antigen-specific immune cells and engineering of target specific immune cells have great potential for cancer eradication. The study aims to evaluate the safety and efficacy of ex vivo manipulated EIE cells including chimeric antigen receptor (CAR) modified immune cells in treating cancer. The primary study objectives are to evaluate the safety of the investigational product, autologous EIE cells, to subjects by intravenous and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous EIE cells ex vivo, and (2) to determine the anti-cancer efficacy of the EIE cells.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Yichun Cai, MD
- Phone Number: 86-13802830754
Study Locations
-
-
Guangdong
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GuangZhou, Guangdong, China, 510415
- Recruiting
- QiFu Hospital of Guangzhou University of Chinese Medicine
-
Contact:
- Yichun Cai, MD
- Phone Number: 86-13802830754
-
ShenZhen, Guangdong, China, 518000
- Recruiting
- Shenzhen Geno-Immune Medical Institute
-
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Yunnan
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KunMing, Yunnan, China, 650000
- Recruiting
- Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
-
Contact:
- Xun Lai, MS
- Phone Number: 13577096609
- Email: 1729112214@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens positive for any one or more of tumor-associated antigens, such as GD2, mesothelin, P16, MMP, Melan A, MAGE A1, MAGE A3, and MAGE A4.
3. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.
7. Not pregnant, and on appropriate birth control if of childbearing potential.
8. Adequate bone marrow reserve with
- absolute neutrophil count (ANC) ≥ 1000/mm3.
- Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with
- Serum creatinine ≤ 2 x upper limit of normal (ULN).
- Serum bilirubin ≤ 2 x ULN.
- aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
- Alkaline phosphatase ≤ 5 x ULN.
- Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
Exclusion Criteria:
1. The results of immune staining of the patient's tumor-associated antigens are all negative.
2. Previous experience of other cell therapy. 3. Participation in any other cell therapy protocols within one year. 4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug.
5. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
6. Pregnant or lactating females. 7. Unable to comply with the trial related requirement. 8. Inadequate bone marrow function:
• Absolute neutrophil count < 1.0 x 10e9/L.• Platelet count < 100 x 10e9/L.• Hb < 9 g/dL.
Inadequate liver and renal function:
- Serum (total) bilirubin > 1.5 x ULN.
- AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases).
- Alkaline phosphatase > 2.5 x ULN (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases).
- Serum creatinine >2.0 mg/dl (> 177 μmol/L).
Urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
9. Serious active infection requiring i.v. antibiotics at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.
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: Single arm
EIE cells to treat cancer.
|
Engineered immune effector cells (EIE)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of adverse effects after EIE cell injection
Time Frame: up to one month
|
To assess the safety of autologous EIE cells in vivo.
The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
|
up to one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of successful EIE generation
Time Frame: up to one month
|
The percentage of successful EIE generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.
|
up to one month
|
Ability of EIE cells to induce anti-cancer reaction
Time Frame: after 1 month from EIE cells infusion until 12 months after infusion
|
measurement of TAA concentration in blood sample
|
after 1 month from EIE cells infusion until 12 months after infusion
|
Ability of EIE cells for anti-cancer reaction
Time Frame: after 1 month from EIE cells infusion until 24 months after infusion
|
Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
CR is disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
|
after 1 month from EIE cells infusion until 24 months after infusion
|
Collaborators and Investigators
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
Keywords
Other Study ID Numbers
- GIMI-IRB-18001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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