Anti-ESO (Cancer/Test Antigen) mTCR-transduced Autologous Peripheral Blood Lymphocytes and Combination Chemotherapy in Treating Patients With Metastatic Cancer That Expresses NY-ESO-1
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|ClinicalTrials.gov Identifier: NCT02774291|
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : March 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|HLA-A2 Positive Cells Present Metastatic Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain||Biological: Aldesleukin Biological: Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes Drug: Cyclophosphamide Biological: Filgrastim Drug: Fludarabine Phosphate Other: Laboratory Biomarker Analysis||Early Phase 1|
I. To determine the safety and tolerability of the administration of anti-ESO (cancer/test antigen) mTCR (T cell receptor)-engineered peripheral blood lymphocytes (anti-thyroglobulin mTCR-transduced autologous peripheral blood lymphocytes) plus high-dose aldesleukin following a nonmyeloablative lymphoid depleting preparative regimen in human leukocyte antigen (HLA)-A2 positive patients with metastatic cancer expressing the ESO antigen.
I. Determine the in vivo survival of T-cell receptor (TCR) gene-engineered cells.
II. Determine the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Patients receive standard cyclophosphamide intravenously (IV) over 1 hour on days -7 to -6 and fludarabine phosphate via intravenous piggy back (IVPB) over 30 minutes on days -5 to -1 followed by anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes IV over 20-30 minutes on day 0 and aldesleukin IV over 15 minutes approximately every 8 hours on days 0-4. Patients also receive filgrastim subcutaneously (SC) on days 1-4.
After completion of study treatment, patients are followed up at 6 weeks, annually for 5 years, and then periodically for 10 years thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Adoptive Cell Transfer for the Treatment of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Treatment (mTCR, aldesleukin)
Patients receive standard cyclophosphamide IV over 1 hour on days -7 to -6 and fludarabine phosphate via IVPB over 30 minutes on days -5 to -1 followed by anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes IV over 20-30 minutes on day 0 and aldesleukin IV over 15 minutes approximately every 8 hours on days 0-4. Patients also receive filgrastim SC on days 1-4.
Biological: Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes
Other Name: Anti-thyroglobulin mTCR-transduced Autologous PBL
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
- Incidence of toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 15 years ]
- In vivo survival of TCR gene-engineered cells [ Time Frame: Up to 15 years ]Descriptive statistics will be used to determine the in vivo survival of TCR gene-engineered cells.
- Objective response rate, graded according to RECIST criteria [ Time Frame: Up to 15 years ]Descriptive statistics will be used to determine the objective response rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774291
|United States, New York|
|Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Ira Braunschweig 718-920-4826 IBRAUNSC@montefiore.org|
|Principal Investigator: Ira Braunschweig|
|Principal Investigator:||Ira Braunschweig||Albert Einstein College of Medicine|