Pankreas Kanserli Hastalarda TAA'ya Özgü Sitotoksik T Lenfositler

Sade dilde özet

Bu çalışma, pankreas kanseri (pancreatic cancer) olan hastalarda, tümörle ilişkili antijenleri (TAA) hedefleyecek şekilde hazırlanmış özel T hücrelerinin (multiTAA'ya özgü T hücreleri) kullanımını incelemiştir. Çalışmaya 18 yaş ve üzeri, biyopsiyle doğrulanmış pankreas adenokarsinomu olan hastalar alınmıştır. Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

Baylor College of Medicine

Müdahale

multiTAA specific T cells

Başlangıç

18.01.2018

Tahmini bitiş

31.07.2025

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States
• Houston, United States
• Houston, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Status - CLOSED TO PATIENT ENROLLMENT (CNPE)

Inclusion Criteria:

PROCUREMENT:

1. Any patient with biopsy proven pancreatic adenocarcinoma.
2. Patients with life expectancy greater than or equal to 6 months.
3. Age greater than or equal to 18 years
4. Hgb greater than or equal to 7.0 g/dl (transfusions allowed)

TREATMENT:

1. 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
2. Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
3. Patients with life expectancy greater than or equal to 12 weeks
4. Age greater than or equal to 18
5. Pulse oximetry of greater than 95 percent on room air in patients who previously received radiation therapy
6. Patients with an ECOG score of ≤ 2 or Karnofsky score of 50 or greater
7. 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).
8. Patients with a creatinine less than or equal to 2x upper limit of normal for age
9. Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
10. For Groups B or C patients must be off conventional therapy for at least 1 week prior to receiving treatment on this study.
11. Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
12. 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:

1. Patients with severe intercurrent infection.
2. Patients with active HIV infection (can be pending at this time)

TREATMENT:

1. Patients with severe intercurrent infection.
2. Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible)
3. Pregnant
4. HIV positive