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A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Advanced Pancreatic Cancer, Pancreatic Adenocarcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anti-EGFR-bispecific antibody armed activated T-cells
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring EGFR-BAT, bispecific antibody-armed activated T cells, Pancreatic cancer, memorial sloan kettering cancer center, 18-463

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • University of Virginia (Specimen Analysis)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pancreatic Adenocarcinoma

Arm Description

Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.

Outcomes

Primary Outcome Measures

Evaluate toxicity
The NCI CTEP CTCAE v4.0 will be used.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2019
Last Updated
May 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04137536
Brief Title
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
Official Title
Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Advanced Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Neoplasms
Keywords
EGFR-BAT, bispecific antibody-armed activated T cells, Pancreatic cancer, memorial sloan kettering cancer center, 18-463

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pancreatic Adenocarcinoma
Arm Type
Experimental
Arm Description
Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.
Intervention Type
Drug
Intervention Name(s)
anti-EGFR-bispecific antibody armed activated T-cells
Other Intervention Name(s)
EGFR BATs
Intervention Description
Phase I: First 3 participants, twice weekly infusions of 10^10 EGFR BATs infusions If there is toxicity in 0 or 1 of 3 participants, 3 additional participants will be added to the dose level of up to 10^10. If >/= 2 of 6 participants experience DLTs, then the dose will be reduced to 7.5 x 10^9 per infusion If only 0 or 1 participants has toxicity in the first 6, then the study will proceed to enroll in the expansion cohort 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)
Primary Outcome Measure Information:
Title
Evaluate toxicity
Description
The NCI CTEP CTCAE v4.0 will be used.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Yu, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Virginia (Specimen Analysis)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33986124
Citation
Park JA, Santich BH, Xu H, Lum LG, Cheung NV. Potent ex vivo armed T cells using recombinant bispecific antibodies for adoptive immunotherapy with reduced cytokine release. J Immunother Cancer. 2021 May;9(5):e002222. doi: 10.1136/jitc-2020-002222.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

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