- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02644655
Immunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia
A Clinical Study Using Autologous T Cell Engineered With Chimeric Antigen Receptor Targeting to CD19(Cluster of Differentiation Antigen 19) in Treating Patients With Recurrent /Refractory B Cell Leukemia
Objectives:
The purpose of this study is to evaluate the safety and prognosis of New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.
Methods:
This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled. Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day-6,-5,-4,-3); nCAR19-T transfusion:day 0(5×10※5/kg,1×10※6/kg,3×10※6/kg). According to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long. Follow-up survey after the clinical study: within 1 months, once a week; then once a month for 1 years; and then once a year, a total of 15 years.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Qijun Qian, PHD
- Telefonnummer: +86-21-65580677
- E-mail: qianqj@sino-gene.cn
Undersøgelse Kontakt Backup
- Navn: Huajun Jin, PHD
- Telefonnummer: +86-21-81875372
- E-mail: hj-jin@hotmail.com
Studiesteder
-
-
-
Shanghai, Kina, 200438
- Rekruttering
- Eastern Hepatobiliary Surgery Hospital
-
Kontakt:
- Huajun Jin, PHD
- Telefonnummer: +86-21-81875372
- E-mail: hj-jin@hotmail.com
-
Ledende efterforsker:
- Qijun Qian, PHD
-
Ledende efterforsker:
- Huajun Jin, PHD
-
Underforsker:
- Yao Huang, MD
-
Underforsker:
- Fuping Zhou, MD
-
Ledende efterforsker:
- Zhengang Yuan, PHD
-
Underforsker:
- Yongmei Ding, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years old, male or female
- Karnofsky≥60%
- At least 2 courses of chemotherapy were performed
- Creatinine is less than 2.5mg/dL;alanine aminotransferase (ALT) / aspartate aminotransferase(AST) less than 3 times of the normal bilirubin is less than 3mg/dL
- Adequate venous access, isolation, and white blood cell production without other taboos
- Signed informed consent
- Patients with fertility are willing to use contraceptive method.
- At least two months after infusion of T cells
Exclusion Criteria:
- Need to use glucocorticoid therapy
- Need immunotherapy
- Creatinine > 2.5mg/dL; ALT / AST > 5 times of the normal; bilirubin > 3mg/dL
- Forced expiratory volume at one second (FEV1)<2 L,diffusing capacity of the lung for carbon monoxide (DLCO)<40%
- congestive cardiac failure (III or IV, NYHA); Significant hypotension; Coronary heart disease Can not be controlled; DLCO<40%
- human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV) patients
- Had received gene therapy
- Significant encephalopathy / new focal neurologic impairment
- Blood culture positive or radiographic evidence of infection
- Other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month
- The history of allergic reactions in cell therapy and cetuximab similar compounds.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: CD19-specific chimeric antigen receptor
After pretreatment, cluster of differentiation antigen 19 (CD19)-specific chimeric antigen receptor will be transfused.
|
Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day 6, 5, 4, 3); nCAR19-T transfusion:day 0(5×105/kg,1×106/kg,3×106/kg).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Occurrence of adverse events and tumor response rate related to study drug
Tidsramme: 2 years
|
2 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Qijun Qian, PHD, Eastern Hepatobiliary Surgery Hospital
Publikationer og nyttige links
Generelle publikationer
- Grupp SA, Kalos M, Barrett D, Aplenc R, Porter DL, Rheingold SR, Teachey DT, Chew A, Hauck B, Wright JF, Milone MC, Levine BL, June CH. Chimeric antigen receptor-modified T cells for acute lymphoid leukemia. N Engl J Med. 2013 Apr 18;368(16):1509-1518. doi: 10.1056/NEJMoa1215134. Epub 2013 Mar 25. Erratum In: N Engl J Med. 2016 Mar 10;374(10):998.
- Maude SL, Frey N, Shaw PA, Aplenc R, Barrett DM, Bunin NJ, Chew A, Gonzalez VE, Zheng Z, Lacey SF, Mahnke YD, Melenhorst JJ, Rheingold SR, Shen A, Teachey DT, Levine BL, June CH, Porter DL, Grupp SA. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014 Oct 16;371(16):1507-17. doi: 10.1056/NEJMoa1407222. Erratum In: N Engl J Med. 2016 Mar 10;374(10):998.
- Kochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, Yang JC, Phan GQ, Hughes MS, Sherry RM, Raffeld M, Feldman S, Lu L, Li YF, Ngo LT, Goy A, Feldman T, Spaner DE, Wang ML, Chen CC, Kranick SM, Nath A, Nathan DA, Morton KE, Toomey MA, Rosenberg SA. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015 Feb 20;33(6):540-9. doi: 10.1200/JCO.2014.56.2025. Epub 2014 Aug 25.
- Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13.
- Davila ML, Riviere I, Wang X, Bartido S, Park J, Curran K, Chung SS, Stefanski J, Borquez-Ojeda O, Olszewska M, Qu J, Wasielewska T, He Q, Fink M, Shinglot H, Youssif M, Satter M, Wang Y, Hosey J, Quintanilla H, Halton E, Bernal Y, Bouhassira DC, Arcila ME, Gonen M, Roboz GJ, Maslak P, Douer D, Frattini MG, Giralt S, Sadelain M, Brentjens R. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med. 2014 Feb 19;6(224):224ra25. doi: 10.1126/scitranslmed.3008226.
- Brentjens RJ, Davila ML, Riviere I, Park J, Wang X, Cowell LG, Bartido S, Stefanski J, Taylor C, Olszewska M, Borquez-Ojeda O, Qu J, Wasielewska T, He Q, Bernal Y, Rijo IV, Hedvat C, Kobos R, Curran K, Steinherz P, Jurcic J, Rosenblat T, Maslak P, Frattini M, Sadelain M. CD19-targeted T cells rapidly induce molecular remissions in adults with chemotherapy-refractory acute lymphoblastic leukemia. Sci Transl Med. 2013 Mar 20;5(177):177ra38. doi: 10.1126/scitranslmed.3005930.
- Porter DL, Levine BL, Kalos M, Bagg A, June CH. Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med. 2011 Aug 25;365(8):725-33. doi: 10.1056/NEJMoa1103849. Epub 2011 Aug 10. Erratum In: N Engl J Med. 2016 Mar 10;374(10):998.
- Ghorashian S, Pule M, Amrolia P. CD19 chimeric antigen receptor T cell therapy for haematological malignancies. Br J Haematol. 2015 May;169(4):463-78. doi: 10.1111/bjh.13340. Epub 2015 Mar 5.
- Maude SL, Shpall EJ, Grupp SA. Chimeric antigen receptor T-cell therapy for ALL. Hematology Am Soc Hematol Educ Program. 2014 Dec 5;2014(1):559-64. doi: 10.1182/asheducation-2014.1.559. Epub 2014 Nov 18.
- Grupp SA. Advances in T-cell therapy for ALL. Best Pract Res Clin Haematol. 2014 Sep-Dec;27(3-4):222-8. doi: 10.1016/j.beha.2014.10.014. Epub 2014 Oct 27.
- Maher J. Clinical immunotherapy of B-cell malignancy using CD19-targeted CAR T-cells. Curr Gene Ther. 2014 Feb;14(1):35-43. doi: 10.2174/1566523213666131223130554.
- Cheadle EJ, Gornall H, Baldan V, Hanson V, Hawkins RE, Gilham DE. CAR T cells: driving the road from the laboratory to the clinic. Immunol Rev. 2014 Jan;257(1):91-106. doi: 10.1111/imr.12126.
- Kochenderfer JN, Dudley ME, Carpenter RO, Kassim SH, Rose JJ, Telford WG, Hakim FT, Halverson DC, Fowler DH, Hardy NM, Mato AR, Hickstein DD, Gea-Banacloche JC, Pavletic SZ, Sportes C, Maric I, Feldman SA, Hansen BG, Wilder JS, Blacklock-Schuver B, Jena B, Bishop MR, Gress RE, Rosenberg SA. Donor-derived CD19-targeted T cells cause regression of malignancy persisting after allogeneic hematopoietic stem cell transplantation. Blood. 2013 Dec 12;122(25):4129-39. doi: 10.1182/blood-2013-08-519413. Epub 2013 Sep 20.
- Terakura S, Yamamoto TN, Gardner RA, Turtle CJ, Jensen MC, Riddell SR. Generation of CD19-chimeric antigen receptor modified CD8+ T cells derived from virus-specific central memory T cells. Blood. 2012 Jan 5;119(1):72-82. doi: 10.1182/blood-2011-07-366419. Epub 2011 Oct 26.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EHBHKY2015-02-007
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Recurrent B-Cell Tumor
-
Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
-
MapKure, LLCRekrutteringSolid tumor | B-Raf mutationsrelaterede tumorerForenede Stater, Australien
-
Antengene (Hangzhou) Biologics Co., Ltd.RekrutteringAvanceret solid tumor | Metastatisk fast tumor | Modent B-celle non-Hodgkin lymfomKina
-
Antengene Biologics LimitedRekrutteringAvanceret solid tumor | Metastatisk fast tumor | Modent B-celle non-Hodgkin lymfomForenede Stater, Australien
-
Merus N.V.Incyte CorporationRekrutteringAvanceret kræft | Solid tumor, voksen | B-celle lymfom, voksenForenede Stater, Spanien, Belgien, Holland
-
Pacylex PharmaceuticalsOzmosis Research Inc.RekrutteringAvanceret solid tumor | B-celle non-hodgkin lymfomCanada
-
Curon Biopharmaceutical (Australia) Co Pty LtdNovotech (Australia) Pty LimitedAfsluttetB-celle lymfom | Avanceret solid tumorØstrig
-
Astellas Pharma IncAfsluttetSolid tumor | B-celle lymfom | Avancerede maligniteter | Positive for Anaplastic Lymphoma Kinase | Positive for Proto-Oncogene Tyrosine-Protein Kinase ROSForenede Stater
-
Epizyme, Inc.AfsluttetMantelcellelymfom | Marginal zone lymfom | Avanceret solid tumor | Diffust storcellet B-celle lymfom | Primært mediastinalt lymfomForenede Stater
-
Cancer Research UKAstraZenecaAfsluttetVoksen fast tumor | Burkitt lymfom | Diffust storcellet B-celle lymfomDet Forenede Kongerige
Kliniske forsøg med CD19-specific chimeric antigen receptor
-
Fondazione Italiana Linfomi - ETSKite, A Gilead CompanyIkke rekrutterer endnuNon-hodgkin lymfom, B-celleItalien
-
Zhejiang UniversityRekrutteringAvancerede solide tumorerKina
-
National Cancer Institute (NCI)AfsluttetLymfom, B-celle | Leukæmi, B-celle | Lymfom, Hodgkins | Lymfom, Non-hodgkinsForenede Stater
-
National Cancer Institute (NCI)AfsluttetLymfom, B-celle | Lymfom, Non-hodgkinsForenede Stater
-
National Institute of Allergy and Infectious Diseases...University of Pennsylvania Clinical Cell and Vaccine Production Facility...Ikke rekrutterer endnuNyresvigt | Slutstadie nyresvigt ved dialyse | NyretransplantationForenede Stater
-
Washington University School of MedicineRekrutteringPædiatriske hæmatologiske maligniteterForenede Stater
-
Kafrelsheikh UniversityIkke rekrutterer endnu
-
National Cancer Institute (NCI)AfsluttetLymfom, B-celle | Kronisk lymfatisk leukæmi | Lymfom, Non-hodgkins | B-celle kronisk lymfatisk leukæmiForenede Stater
-
National Cancer Institute (NCI)RekrutteringB Akut lymfatisk leukæmi med t(9;22)(q34.1;q11.2); BCR-ABL1Forenede Stater, Puerto Rico, Israel