Phase 2
N=37
TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03192462 ↗Enrolled (actual)
37
Serious AEs
35.1%
Results posted
Aug 2023
Primary outcome: Primary: Number of Patients With Treatment Related Serious Adverse Events — 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- multiTAA specific T cells (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Treatment Related Serious Adverse Events |
0; 1; 0 | — |
| PRIMARY Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells |
9; 2; 4 | — |
| SECONDARY Progression Free Survival Using the Kaplan-Meier Method |
6.4; 2.2; 7.5 | — |
| SECONDARY Overall Survival Using the Kaplan-Meier Method |
14.1; 4.4; 12.6 | — |
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.*
Eligibility Criteria
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Inclusion Criteria
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
- Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, Hgb greater than or equal to 7.0 g/dl (transfusion allowed).
- Patients with a creatinine less than or equal to 2x upper limit of normal for age
- Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
- For Groups B or C patients must be off conventional therapy for at least 1 week prior to receiving treatment on this study.
- Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT03192462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.