Treatment of Advanced Solid Tumors With TSA-CTL(Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes)
Phase I Clinical Trial of TSA-CTL (Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes) In the Treatment of Advanced Solid Tumors
3 other identifiers
interventional
11
1 country
1
Brief Summary
The primary objective of this study is to evaluate the safety of TSA-CTL in the treatment of advanced solid tumors. The secondary objective of this study is to evaluate preliminarily the effect of TSA-CTL in the treatment of advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedStudy Start
First participant enrolled
December 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedFebruary 2, 2023
February 1, 2023
3.7 years
October 21, 2016
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events as assessed by CTCAE v5.0.
Keep records the adverse events experienced by subjects in 30 days after the first infusion.
one month
Secondary Outcomes (4)
Disease Control Rate(DCR)
one year
overall survival(OS)
one year
progression-free survival(PFS)
one year
Duration of Response(DOR)
one year
Study Arms (3)
medium-dose lymphodepletion regimen
EXPERIMENTALPatients will receive medium-dose lymphodepletion regimen consisting of cyclophosphamide and fludarabine followed by TSA-CTL.
low-dose lymphodepletion regimen
EXPERIMENTALPatients will receive low-dose lymphodepletion regimen consisting of cyclophosphamide and fludarabine followed by TSA-CTL.
No lymphodepletion regimen
EXPERIMENTALPatients will only receive TSA-CTL.
Interventions
Patients will receive TSA-CTL iv over 20-30 minutes on day 0.
Cyclophosphamide 500 mg/m2/day iv on day -5 for one day.
Fludarabine 25 mg/m2/day iv over 30 minutes on day -5 and -4 for two days.
Eligibility Criteria
You may qualify if:
- Greater than or equal to 18 years of age and less than or equal to 70 years of age; all genders.
- Advanced solid tumors including but not limited to some high frequency somatic mutations, such as melanoma, colorectal cancer, gastric cancer, esophageal cancer, squamous cell carcinoma of the lung, triple-negative breast cancer, etc.
- Advanced solid tumors patients who are HLA - A0201 /A1101/A2402 subtypes.
- Measurable solid tumors with at least one lesion that is resectable or tumor biopsies for DNA extraction.
- Patients who failed or were intolerant to standard treatment.
- Patients (or their legal representatives) who are able to understand and sign the Informed Consent Form and willing to sign a durable power of attorney.
- Clinical performance status of ECOG is 0 or 1 and expected lifetime is greater than six month and patients who are able to cooperate to observe adverse reactions and the effect of the treatment.
- Patients of both genders must be willing to practice birth control from the time of enrollment to five months after treatment on this study.
- Serology: HIV antibody(-), hepatitis B antigen(-), and hepatitis C antibody(-). A fertile woman must have a negative pregnancy test. Hematology: Absolute neutrophil count is greater than 1500/mm3 without the support of filgrastim; WBC is greater than or equal to 3000/mm3; lymphocyte count is greater than or equal to 800/mm3; Platelet count is greater than or equal to 100,000/mm3; Hemoglobin is greater than or equal to 9.0 g/dL ; Chemistry: Serum ALT/AST is less than or equal to 2.5 times the upper limit of normal; Serum Creatinine is less than or equal to 1.5 times the upper limit of normal ; Total bilirubin is less than or equal to 1.5 the upper limit of normal, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 times the upper limit of normal.
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the lymphodepletion regimen, and toxicities must have recovered to grade 1 or less (except for toxicities such as alopecia or vitiligo).
- Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.
You may not qualify if:
- Pregnant or lactating women.
- Any primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Opportunistic infection.
- History of autoimmune disease.
- Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
- Systemic steroid therapy in the past 4 weeks.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Patients with unstable brain metastases.
- Choroidal melanoma and clear cell sarcoma patients.
- Negative for expression of MHC molecules.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BGI, Chinalead
- Sun Yat-sen Universitycollaborator
Study Sites (1)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510030, China
Related Publications (4)
Tran E, Turcotte S, Gros A, Robbins PF, Lu YC, Dudley ME, Wunderlich JR, Somerville RP, Hogan K, Hinrichs CS, Parkhurst MR, Yang JC, Rosenberg SA. Cancer immunotherapy based on mutation-specific CD4+ T cells in a patient with epithelial cancer. Science. 2014 May 9;344(6184):641-5. doi: 10.1126/science.1251102.
PMID: 24812403RESULTCarreno 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: 25837513RESULTPrickett TD, Crystal JS, Cohen CJ, Pasetto A, Parkhurst MR, Gartner JJ, Yao X, Wang R, Gros A, Li YF, El-Gamil M, Trebska-McGowan K, Rosenberg SA, Robbins PF. Durable Complete Response from Metastatic Melanoma after Transfer of Autologous T Cells Recognizing 10 Mutated Tumor Antigens. Cancer Immunol Res. 2016 Aug;4(8):669-78. doi: 10.1158/2326-6066.CIR-15-0215. Epub 2016 Jun 16.
PMID: 27312342RESULTLi D, Chen C, Li J, Yue J, Ding Y, Wang H, Liang Z, Zhang L, Qiu S, Liu G, Gao Y, Huang Y, Li D, Zhang R, Liu W, Wen X, Li B, Zhang X, Zhang X, Xu RH. A pilot study of lymphodepletion intensity for peripheral blood mononuclear cell-derived neoantigen-specific CD8 + T cell therapy in patients with advanced solid tumors. Nat Commun. 2023 Jun 10;14(1):3447. doi: 10.1038/s41467-023-39225-7.
PMID: 37301885DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiao Sh Zhang, Doctor
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2016
First Posted
November 9, 2016
Study Start
December 22, 2016
Primary Completion
September 1, 2020
Study Completion
May 20, 2022
Last Updated
February 2, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share