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New treatment option for Cancer
Official title Immunotherapy Treating GI Cancer
ClinicalTrials.gov ID: NCT03614650
What this study is testing
What is engineered immune cells?
engineered immune cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objectives are to evaluate the safety and efficacy of infusion of autologous gastro-intestinal (GI) cancer antigen-specific engineered immune effector cells (EIE).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 80
You may be able to join if
- 1\. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens...
- absolute neutrophil count (ANC) ≥ 1000/mm3. Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with Serum creatinine ≤ 2 x upper limit of...
You likely can't join if
- 1\. The results of immune staining of the patient's tumor-associated antigens are all negative. 2\. Participation in any other cell therapy protocols...
- 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).
See the full eligibility 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...
- 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...
- 1\. The results of immune staining of the patient's tumor-associated antigens are all negative. 2\. Participation in any other cell therapy protocols within one year. 3. Current or recent treatment (within the 28-day...
- 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. 8\. Serious active...
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.