TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor

NCT03185429 | Unknown

• 1 other identifier: BGI-002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.

Conditions

Tumor Gastric; Tumor, Colorectal

Outcome Measures

Primary Outcomes (3)

• safety endpoint

  All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.

  one year

• Overall Response Rate

  Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.

  one year

• Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood.

  one year

Secondary Outcomes (6)

• Secondary safety endpoint

  one year

• Six month DCR(CRR+PRR+SDR)

  6 month

• Duration of Response(DOR)

  one year

• Progression-free survival(PFS)

  one year

• rate of 12-month survival

  one year

Study Arms (1)

Experimental

EXPERIMENTAL

Drug:Cyclophosphamide Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells

Biological: Tumor Specific Antigen-loaded Dendritic Cells; Drug: Cyclophosphamide

Interventions

Tumor Specific Antigen-loaded Dendritic Cells BIOLOGICAL

Subjects will be given subcutaneous injection of 5.0x10\^6-1.0x10\^7 TSA-DC on week 1,3,5,11,17,23,35,47.

Also known as: TSA-DC vaccine

Experimental

Cyclophosphamide DRUG

300 mg/m2 by vein before the first cell infusion.

Also known as: Cytoxan

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥18 and ≤75,no gender based;
• Expression of HLA-A0201/1101/2402;
• Histopathologic documentation of gastrointestinal solid tumors(stomach cancer or colorectal cancer ) concurrent with the diagnosis of metastatic disease, and the tumor is Measurable;
• Patients must have adequate tissue (fresh or paraffin block) for DNA extraction, which is used for gene sequencing, and prognoses the tumor specific antigen in turn,can predict to have new tumor antigens with high affinity for MHC molecules;
• Failure in conventional treatment， or though benefit from chemotherapy the patient can't tolerant subjectively;
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 and an anticipate life expectancy of at least three months,be cooperate to adverse reactions monitoring and therapeutic evaluation of the treatment;
• Participants of child-bearing potential must agree to use adequate contraceptive methods up to 12 months after the pretreatment;
• Serology：Seronegative for HIV antibody,seronegative for hepatitis C antibody. Hematology：Absolute neutrophil count ≥ 1000/mm(3) without the support of filgrastim ,WBC ≥ 3000/mm(3)，lymphocyte count ≥ 800/mm(3)，Platelet count ≥ 100,000/mm(3)，Hemoglobin ≥ 9.0 g/dl Chemistry：Serum ALT/AST ≤ 2.5 times the upper limit of normal，Serum Creatinine ≤1.6 mg/dl，Total bilirubin \< 1.5 mg/dl, except in patients with Gilbert s Syndrome who must have a total bilirubin \< 3.0 mg/dl;
• Patients or their legal representatives are willing and able to understand and written informed consent form for the trial;

You may not qualify if:

• Is pregnant or breastfeeding,or expecting to conceive;
• Have a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
• Suffered grade 3-4 major organ immune-related adverse events after anti-PD1/PDL1 antibody treatment.
• Once received allogeneic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, except for corneal transplantation);
• Have clinical symptoms of central nervous system metastases;
• Have used a large number of glucocorticoids or other immunosuppressive agents within 4 weeks;
• Have any active autoimmune disease ;
• Be in active infection or undergo an unknown cause fever\> 38.5 ℃ during screening or before the first administration(except tumor fever which evaluated by the researchers have no effect to enrollment );
• Received chemotherapy or small molecule targeted drug therapy in 4 weeks prior to chemotherapy pretreatment;
• Received any antibody drug therapy (including PD-1 and CTLA-4) within 6 weeks before the treatment period;
• Severe liver and kidney dysfunction or uncontrollable diabetes, hypertension and other chronic systemic diseases; severe coagulation disorders, mental illness, cardiopulmonary disease，hydrothorax or ascites;

Sponsors & Collaborators

• BGI, China: lead
• Fujian Cancer Hospital: collaborator

Related Publications (3)

• Chiang CL, Kandalaft LE, Tanyi J, Hagemann AR, Motz GT, Svoronos N, Montone K, Mantia-Smaldone GM, Smith L, Nisenbaum HL, Levine BL, Kalos M, Czerniecki BJ, Torigian DA, Powell DJ Jr, Mick R, Coukos G. A dendritic cell vaccine pulsed with autologous hypochlorous acid-oxidized ovarian cancer lysate primes effective broad antitumor immunity: from bench to bedside. Clin Cancer Res. 2013 Sep 1;19(17):4801-15. doi: 10.1158/1078-0432.CCR-13-1185. Epub 2013 Jul 9.

  PMID: 23838316 BACKGROUND

• Schuler PJ, Harasymczuk M, Visus C, Deleo A, Trivedi S, Lei Y, Argiris A, Gooding W, Butterfield LH, Whiteside TL, Ferris RL. Phase I dendritic cell p53 peptide vaccine for head and neck cancer. Clin Cancer Res. 2014 May 1;20(9):2433-44. doi: 10.1158/1078-0432.CCR-13-2617. Epub 2014 Feb 28.

  PMID: 24583792 BACKGROUND

• Carreno BM, Magrini V, Becker-Hapak M, Kaabinejadian S, Hundal J, Petti AA, Ly A, Lie WR, Hildebrand WH, Mardis ER, Linette GP. Cancer immunotherapy. A dendritic cell vaccine increases the breadth and diversity of melanoma neoantigen-specific T cells. Science. 2015 May 15;348(6236):803-8. doi: 10.1126/science.aaa3828. Epub 2015 Apr 2.

  PMID: 25837513 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• ZengQing Guo, Professor

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Chen, Doctor

CONTACT

13859089836; fannychenling05@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 14, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 14, 2017

Record last verified: 2017-08