Allojenik Kök Hücre Nakli Sonrası Nüks Eden CD19+ Kanserlerde CAR Taşıyan Aktive T Lenfositleri (CARPASCIO)

Sade dilde özet

Bu Faz 1 (Phase 1) gen transferi çalışması, Hodgkin dışı lenfoma (non-Hodgkin lymphoma, NHL), akut lenfositik lösemi (acute lymphocytic leukemia, ALL) veya kronik lenfositik lösemi (chronic lymphocytic leukemia, CLL) tedaviden sonra nüks eden ya da geçmeyen hastalarda CD19.CAR-CD28Z T hücrelerini iki doz artırım düzeyinde incelemektedir. Yaklaşım, antikorların hedefe bağlanma özelliği ile T hücrelerinin hücre öldürme yeteneğini birleştirmektedir. Katılım için CD19+ B-ALL ya da CD19+ B hücreli CLL/NHL nedeniyle allojenik kök hücre nakli (allogeneic HSCT) süreci, en az 12 hafta yaşam beklentisi ve uygun bir donörün belirlenmiş olması gerekmektedir.

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

CD19.CAR-CD28Z T Cells - dose escalation 2, CD19.CAR-CD28Z T Cells - dose escalation 1

Başlangıç

01.04.2014

Tahmini bitiş

01.12.2030

Ülkeler

United States

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:

PROCUREMENT

* Group A: CD19+ B-ALL undergoing allogeneic HSCT or Group B: CD19+ B cell CLL or NHL undergoing allogeneic HSCT
* Life expectancy of ≥12 weeks.
* Patient has an appropriate donor identified for hematopoietic stem cell transplantation

TREATMENT

* Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A) OR any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B)
* Residual disease at the time of transplant (bulky or minimal) or post transplant relapse as evidenced by PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy or in the peripheral blood. MRD will be defined as detection in blood or marrow of any of the following:

  * Any leukemia specific marker (such as t(9:22) or t(4:11)) documented in the patient's leukemia cells pre transplant on a post transplant evaluation.
  * An immune globulin rearrangement known to be a disease marker for this patient post transplant.
  * A leukemia specific phenotype post transplant at a level of ≥ 0.01%
  * Mixed donor chimerism (any level)
* Life expectancy ≥ 6 weeks
* Karnofsky/Lansky score ≥ 50%.
* Bilirubin ≤ 2 times the upper limit of normal.
* AST ≤ 3 times the upper limit of normal.
* Estimated GFR \> 50 mL/min
* Hgb ≥ 7.0 (can be a transfused value)
* Pulse oximetry of \> 90% on room air
* Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after ATL infusion. The male partner should use a condom.
* Available allogeneic activated peripheral blood T cell products with \>=15% expression of CD19.CAR-CD28ζ determined by flow cytometry (cell dose is based on total cell numbers and not individual antileukemic cell numbers).
* No other investigational antitumor therapy for one month prior to entry in this study.
* Patients or legal guardians must sign an informed consent.

Exclusion Criteria:

* Severe intercurrent infection.
* Evidence of GVHD \> grade II.
* Pregnant or lactating.
* History of hypersensitivity reactions to murine protein-containing products.
* Currently taking corticosteroids (\>0.5 mg/kg/day prednisone or equivalent) for therapy of GVHD.