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TERMINATEDPHASE1

CD8+ T Cell Therapy and Pembrolizumab in Treating Patients With Metastatic Gastrointestinal Tumors

Pilot Study of Feasibility and Safety of Personalized Autologous CD8+ T Cell Therapy Plus Anti-PD1 Antibody in Advanced Solid Malignancies

NCT02757391•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase I pilot trial studies the side effects of cluster of differentiation 8 (CD8)+ T cells in treating patients with gastrointestinal tumors that have spread to other places in the body. Tumor cells and blood are used to help create an adoptive T cell therapy, such as CD8+ T cell therapy, that is individually designed for a patient and may help doctors learn more about genetic changes in the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CD8+ T cell therapy and pembrolizumab may work better in treating patients with gastrointestinal tumors.

Detailed Description

PRIMARY OBJECTIVES: I. Assess the safety of using a personalized adoptive T cell therapy in patients with advanced gastrointestinal malignancies. SECONDARY OBJECTIVES: I. Assess the persistence of an immune response after T cell infusion. II. Determine the clinical benefit of adoptive T cell therapy in advanced gastrointestinal cancers. OUTLINE: Beginning 2 days prior to CD8+ T cell infusion, patients receive cyclophosphamide intravenously (IV) over 30 minutes. Patients undergo CD8+ T cell infusion IV over 2 hours on day 0 and receive aldesleukin subcutaneously (SC) twice daily (BID) on days 1-14. Beginning on day 1 about 24 hours after CD8+ T cell infusion, patients receive pembrolizumab IV over 30-60 minutes on weeks 3, 6, 12, and 15. After completion of study treatment, patients are followed up for 24 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inclusion:
•1. Histopathologic documentation of pancreatic adenocarcinoma, colorectal adenocarcinoma, cholangiocarcinoma, esophageal cancer and gastric cancer with radiographic evidence of metastatic disease.
•2. Male or female subjects greater than or equal to 18 years of age.
•3. ECOG/ Zubrod performance status of 0 or 1.
•4. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for at least 8 weeks after pembrolizumab is stopped. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. Acceptable forms of birth control include condom, diaphragm, hormonal, IUD, or sponge plus spermacide. Abstinence is also an acceptable form of birth control.
•5. Men must be willing and able to use an acceptable method of birth control, during and for at least 3 months after completion of the study, if their sexual partners are WOCBP.
•6. Willing and able to give informed consent.
•7. Adequate vein access: consider PICC or other central line.
•8. Patients must have adequate tissue (fresh or frozen) available or planned removal of adequate tissue for analysis. At least 250mg of tumor are needed for peptide elution. There is no specific time limit on how long the tissue can remain frozen prior to use. The tissue will be collected and analyzed under Lab protocol PA15-0176.
•9. Patients can have any lines (including zero) of prior therapy to sign consent prior to tissue harvest.
+14 more criteria

Exclusion Criteria

•10. Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception. Women of childbearing potential with a positive pregnancy test within 3 days prior to entry.
•11. Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy.
•12. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•13. Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any anti-PD-1 dose.
•14. After the T cell infusion, patients may not be on any other treatments for their cancer aside from those included in the treatment section of the protocol.
•15. Coagulation ≤1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or a PTT is within therapeutic range of intended use of anticoagulants.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 9, 2019

Primary Completion Date

October 2, 2020

Completion Date

October 2, 2020

Last Updated

October 30, 2020

Enrollment

ACTUAL participants

Conditions

Colorectal AdenocarcinomaMetastatic CholangiocarcinomaMetastatic Colorectal CarcinomaMetastatic Digestive System CarcinomaMetastatic Esophageal CarcinomaMetastatic Gastric CarcinomaMetastatic Pancreatic AdenocarcinomaStage IV Colorectal Cancer AJCC v7Stage IV Esophageal Cancer AJCC v7Stage IV Gastric Cancer AJCC v7Stage IV Pancreatic Cancer AJCC v6 and v7Stage IVA Colorectal Cancer AJCC v7Stage IVB Colorectal Cancer AJCC v7

Interventions

Adoptive Immunotherapy

BIOLOGICAL

Aldesleukin

BIOLOGICAL

Cyclophosphamide

DRUG

Laboratory Biomarker Analysis

OTHER

Pembrolizumab

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CD8+ T Cell Therapy and Pembrolizumab in Treating Patients With Metastatic Gastrointestinal Tumors

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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