TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer

NCT03192462 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: H-40378 TACTOPS
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

Brief Summary

Status - CLOSED TO PATIENT ENROLLMENT (CNPE) Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have surgery after treatment for pancreatic cancer are eligible for this study. This is a research study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy. The proteins that are targeted in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, five common TAAs will be targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe. Investigators now want to try this treatment in patients with pancreatic cancer. These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration. \*Arm A and Arm B are closed to new patient enrollment.\*

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Immune-based therapies; CytotoxicT Lymphocytes

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Treatment Related Serious Adverse Events

  To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.

  7 months

• Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells

  To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease

  6 months

Secondary Outcomes (2)

• Progression Free Survival Using the Kaplan-Meier Method

  5 years

• Overall Survival Using the Kaplan-Meier Method

  5 years

Study Arms (3)

Group A (Closed to New Patient Enrollment)

EXPERIMENTAL

Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4.

Biological: multiTAA specific T cells

Group B (Closed to New Patient Enrollment)

EXPERIMENTAL

Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells.

Biological: multiTAA specific T cells

Group C (Closed to New Patient Enrollment)

EXPERIMENTAL

Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery.

Biological: multiTAA specific T cells

Interventions

multiTAA specific T cells BIOLOGICAL

Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.

Group A (Closed to New Patient Enrollment); Group B (Closed to New Patient Enrollment); Group C (Closed to New Patient Enrollment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PROCUREMENT:
• Any patient with biopsy proven pancreatic adenocarcinoma.
• Patients with life expectancy greater than or equal to 6 months.
• Age greater than or equal to 18 years
• Hgb greater than or equal to 7.0 g/dl (transfusions allowed)
• TREATMENT:
• Any patient with biopsy-proven pancreatic adenocarcinoma:
• Group A: Patients with locally advanced or metastatic adenocarcinoma who are responding (defined as stable disease or tumor volume reduction) following 3 cycles of first line chemotherapy
• Group B: Patients with locally advanced or metastatic adenocarcinoma who have failed first line chemotherapy or are intolerant, ineligible or unwilling to receive standard of care chemotherapy
• Group C: Patients with resectable pancreatic cancer who have completed planned neo-adjuvant chemotherapy, radiotherapy or combination
• Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
• Patients with life expectancy greater than or equal to 12 weeks
• Age greater than or equal to 18
• Pulse oximetry of greater than 95 percent on room air in patients who previously received radiation therapy
• Patients with an ECOG score of ≤ 2 or Karnofsky score of 50 or greater

You may not qualify if:

• PROCUREMENT:
• Patients with severe intercurrent infection.
• Patients with active HIV infection (can be pending at this time)
• TREATMENT:
• Patients with severe intercurrent infection.
• Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible)
• Pregnant
• HIV positive

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator
• The Methodist Hospital Research Institute: collaborator
• Pancreatic Cancer Action Network: collaborator
• The V Foundation for Cancer Research: collaborator
• Harris County Hospital District: collaborator

Study Sites (3)

Baylor Clinic

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Harris Health System - Smith Clinic

Houston, Texas, 77054, United States

Location

Related Publications (1)

• Musher BL, Vasileiou S, Smaglo BG, Robertson CS, Wu M, Wang T, Watanabe A, Kuvalekar M, Velazquez Y, Ketkar S, Doheyan TA, Papayanni PG, Shah A, Lapteva N, Grilley BJ, Van Buren G, Lulla PD, Heslop HE, Rooney CM, Brenner MK, Leen AM. Autologous multiantigen-targeted T cell therapy for pancreatic cancer: a phase 1/2 trial. Nat Med. 2026 Jan;32(1):258-269. doi: 10.1038/s41591-025-04043-5. Epub 2026 Jan 2.

  PMID: 41482561 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Benjamin Musher
• Organization: Baylor College of Medicine

blmusher@bcm.edu

(713)798-3750

Study Officials

• Anne Leen, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Benjamin Musher, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is designed as a fixed-dose pilot study to evaluate the safety and feasibility and efficacy of up to 6 intravenous infusions of multiTAA-specific T cells in pancreas cancer patients with metastatic, locally advanced unresectable, or resectable disease.

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: January 18, 2018
• Primary Completion: June 15, 2020
• Study Completion: July 31, 2025
• Last Updated: October 29, 2025
• Results First Posted: August 1, 2023

Record last verified: 2025-10

Locations

US (3)