A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04137536 |
Recruitment Status :
Active, not recruiting
First Posted : October 24, 2019
Last Update Posted : October 10, 2022
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Cancer Advanced Pancreatic Cancer Pancreatic Adenocarcinoma Pancreatic Neoplasms | Drug: anti-EGFR-bispecific antibody armed activated T-cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs) |
Actual Study Start Date : | October 17, 2019 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | April 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Pancreatic Adenocarcinoma
Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.
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Drug: anti-EGFR-bispecific antibody armed activated T-cells
Phase I:
Expansion cohort: - 8 infusions of 7.5 x 10^9 or 10^10 EGFR BATs in 22 evaluable participants (including the 6 participants treated at the maximum tolerated dose in Phase I) Other Name: EGFR BATs |
- Evaluate toxicity [ Time Frame: 1 year ]The NCI CTEP CTCAE v4.0 will be used.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS>/= 70% or SWOG performance Status 0 or 1
- Evaluable disease by iRECIST criteria
- Absolute Neutrophil Count (ANC) >/= 1,000/mm^3
- Lymphocyte count >/= 400/mm^3
- Platelet Count >/= 75,000/mm^3
- Hemoglobin >/= 8 g/dL
- Serum Creatinine < 2.0 mg/dl, Creatinine Clearance >/=50 ml/mm (can be calculated or measured)
- Total Bilirubin </= 2 mg/dl (biliary stent is allowed)
- SGPT and SGOT <5.0 times normal
- LVEF >/= 55% at rest (<UGA or Echo)
- Age >/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information)
- Females of childbearing potential, and males, must be willing to use an effective method of contraception
- Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Exclusion Criteria:
- Any chemotherapy related toxicities from prior treatment, > grade 2 per CTCAE v4.0
- Known hypersensitivity to cetuximab or other EGFR antibody
- Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
- Symptomatic brain metastasis
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
- Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known HIV infection
- Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
- Has an active infection requiring systemic therapy
- A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy.
- Females must not be breastfeeding
- Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant

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): NCT04137536
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Virginia | |
University of Virginia (Specimen Analysis) | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Kenneth Yu, MD | Memorial Sloan Kettering Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT04137536 |
Other Study ID Numbers: |
18-463 |
First Posted: | October 24, 2019 Key Record Dates |
Last Update Posted: | October 10, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
EGFR-BAT bispecific antibody-armed activated T cells Pancreatic cancer memorial sloan kettering cancer center 18-463 |
Pancreatic Neoplasms Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Antibodies Antibodies, Bispecific Immunologic Factors Physiological Effects of Drugs |