AML veya MDS için Verici Kaynaklı Multi TAA-Spesifik T Hücrelerinin Uygulanması (ADSPAM)

Sade dilde özet

Bu çalışma, verici kaynaklı MultiTAA-spesifik T hücreleri adlı bir hücre tedavisini, akut miyeloid lösemi (acute myeloid leukemia, AML) veya miyelodisplastik sendrom (myelodysplastic syndrome, MDS) hastalarında incelemiştir. Çalışmaya, allojenik kök hücre nakli yapılan ve bu hücreleri destekleyici tedavi ya da nüks/dirençli hastalık tedavisi olarak alacak hastalar dahil edilmiştir. Çalışma Faz 1 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

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

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Devam ediyor, katılım kapalı

Sponsor

Baylor College of Medicine

Müdahale

MultiTAA-specific T cells

Başlangıç

01.02.2016

Tahmini bitiş

01.02.2027

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States
• Houston, United States

Uygunluk kriterleri

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

Inclusion Criteria:

1. Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as;

   (i) Adjuvant therapy for AML/MDS (Group A) or

   (ii) Treatment for refractory/relapsed or minimal residual AML/MDS disease (Group B)

   Residual disease at the time of transplant or post transplant relapse is defined as PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy, in the peripheral blood or any other extramedullary sites.

   Minimal residual disease (MRD) will be defined as detection in blood, bone marrow, or other tissues of any of the following:

   (i) Any leukemia specific marker such as t(8;21); inv 16; t (15;17), t(9;22) or t(4;11) documented in the patient's leukemia cells pre-transplant on a post-transplant evaluation.

   (ii) Expression of a leukemia associated antigen known to be a marker for residual disease like WT1.

   (iii) A leukemia-specific phenotype (e.g. expression of markers including CD13 and/or CD33 and/or CD117 and/or HLA-DR+) post-transplant at a level of ≥ 0.01%.

   (ix) Mixed donor chimerism (\> 20%).
2. Life expectancy ≥ 6 weeks.
3. Karnofsky/Lansky score of ≥ 50.
4. Patient or parent/guardian capable of providing informed consent.
5. Bilirubin ≤ 2X upper limit of normal.
6. AST ≤ 3X upper limit of normal.
7. Undergoing stem cell transplant at CAGT.
8. Serum creatinine ≤ 2X upper limit of normal.
9. Hgb ≥ 7.0 g/dL (can be transfused).
10. Pulse oximetry of \> 90% on room air.
11. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion. Male partner should use a condom.
12. Available donor-derived multiTAA-specific T cell line.
13. No other investigational anti-neoplastic therapy for one month prior to entry in this study.

Exclusion Criteria:

1. Patients receiving ATG or Campath within 28 days of infusion.
2. Patients receiving a Donor Lymphocyte Infusion within 4 weeks of planned T cell infusion.
3. Less than 30 days post-allogeneic stem cell transplant.
4. Severe intercurrent infection.
5. Evidence of GVHD \> Grade II.
6. Pregnant or lactating.
7. Currently taking corticosteroids (\> 0.5 mg/kg/day prednisone or equivalent).