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Administration of Donor MultiTAA-Specific T Cells for ALL
Bu çalışma, verici kaynaklı MultiTAA-spesifik T hücreleri adlı bir hücre tedavisini, akut lenfoblastik lösemi (acute lymphoblastic leukemia, ALL) hastalarında incelemiştir. Çalışmaya, allojenik kök hücre nakli yapılan ve bu hücreleri destekleyici tedavi ya da nüks/kalıntı hastalık tedavisi olarak alacak hastalar dahil edilmiştir. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: Only patients who receive infusions in the integrated Cell and Gene Therapy (CAGT) Transplant program at Texas Children's Hospital (TCH) or Houston Methodist Hospital (HMH) are eligible for this study. 1. Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as: (i) Adjuvant therapy for ALL (Group A), or (ii) Treatment for relapsed/residual ALL 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 or in the peripheral blood. Minimal residual disease (MRD )will be defined as detection in blood or marrow of any of the following: (i) Any leukemia-specific marker (such as t(12;21); t(9;22) or t(4;11)) documented in the patient's leukemia cells pre-transplant on a post-transplant evaluation. (ii) A leukemia-specific phenotype (e.g. expression of markers including CD10 and/or CD19 or CD3 and/or CD4 or CD8) post-transplant at a level greater than or equal to 0.01%. (iii) Mixed donor chimerism (greater than 20%). 2. Life expectancy greater than or equal to 6 weeks. 3. Karnofsky/Lansky score of greater than or equal to 50. 4. Patient or parent/guardian capable of providing informed consent. 5. Bilirubin less than or equal to 2X upper limit of normal. 6. AST less than or equal to 3X upper limit of normal. 7. Serum creatinine less than or equal to 2X upper limit of normal. 8. Hgb greater than or equal to 7.0 g/dL (can be transfused). 9. Pulse oximetry of greater than 90% on room air. 10. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ATL infusion. Male partner should use a condom. 11. Available donor-derived multiTAA-specific T cell line. 12. No other investigational anti-neoplastic therapy for one month prior to entry in this study. 13. Undergoing Stem Cell Transplant at CAGT Exclusion Criteria: 1. Patients receiving ATG or Campath within 28 days of infusion. 2. Patients receiving a Donor Lymphocyte Infusion (DLI) 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 greater than Grade II. 6. Pregnant or lactating. 7. Currently taking corticosteroids (greater than 0.5 mg/kg/day prednisone or equivalent). Donor Eligibility: Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have fulfilled eligibility for and consented to stem cell donation as per the stem cell transplant program's standard operating procedures. Subjects must be at least 12 kg or 24 pounds to be eligible for stem cell donation. The stem cell donor will have already been selected by the primary Bone Marrow Transplant attending according to CAGT SOPs for Donor Evaluation, Donor Selection, and Donor Deferral. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for T cell generation, provided that there are no new reasons for ineligibility since the stem cell collection. In this study, the subject's hematopoietic stem cell donor will also be the donor for the T cells.