B-Hücre Kökenli Lenfoid Kötü Huylu Hastalıkları Olan Hastalarda CD19'a Özgü T Hücre İnfüzyonu

Sade dilde özet

Bu çalışma, CD19 taşıyan B-hücre kökenli lenfoma/lösemi hastalarında, genetik olarak CD19'u hedefleyecek şekilde değiştirilmiş T hücrelerinin (bir tür bağışıklık hücresi) kök hücre nakliyle birlikte verilmesini inceliyor. İlk remisyonun ötesinde veya tedaviye dirençli, 18-75 yaş arası hastalar dahil edilmiştir. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

M.D. Anderson Cancer Center

Müdahale

Leukapheresis, Stem Cell Transplant, CD19-specific T Cell Infusion, IL-2, Carmustine, Etoposide, Cytarabine, Melphalan

Başlangıç

20.06.2011

Tahmini bitiş

23.04.2020

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States

Uygunluk kriterleri

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

Inclusion Criteria:

1. Patients with a history of CD19+ lymphoid malignancies that are beyond first remission or primary refractory to treatment.
2. Age 18 to 75 years.
3. Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
4. Patient able to provide written informed consent.
5. Patient able to provide written informed consent for the long-term follow-up gene therapy study.
6. Eligibility at time of transplant conditioning regimen (criteria 6-13): Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
7. Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
8. No symptomatic pulmonary disease. FEV1, FVC and DLCO \>/= 50% of expected, corrected for hemoglobin.
9. Serum creatinine \</= 1.8mg/dL or creatinine clearance \>/= 40 cc/min.
10. Adequate hepatic function, as defined by SGPT \<3 X upper limit of normal; serum bilirubin and alkaline phosphatase \<2 X upper limit of normal, or considered not clinically significant.
11. If positive Hepatitis B and/or Hepatitis C serology, discuss with Principal Investigator or designee and consider liver biopsy.
12. No pleural/pericardial effusion or ascites estimated to be \>1L.
13. Not breast feeding or pregnant. Pregnancy determined by a positive beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
14. Eligibility at time of T-cell infusion (criteria 14-15): No systemic corticosteroids within 3 days prior to T-cell infusion.
15. Not experiencing any new Grade \>2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to T-cell infusion.
16. Eligibility criteria for administration of IL-2 after T-cell infusion: Absence of new adverse event of grade \>2 (CTC vs. 4) involving cardiopulmonary, hepatic (excluding albumin), gastrointestinal, neurologic, or renal toxicity probably or definitely attributed to infused T cells within one week of cells.

Exclusion Criteria:

1. Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
2. Patients with known allergy to bovine or murine products.
3. Positive serology for HIV.