- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02924753
The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Henan
-
Zhengzhou, Henan, Kina
- Rekruttering
- Henan Cancer Hospital
-
Kontakt:
- Yongping Song
- E-mail: ph200811@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 4 years to 70 years, expected survival > 3 months
- CD19 positive B-cell acute lymphoblastic leukemia
- Karnofsky Performance Status (KPS) >70
- Relapsed after allogeneic or autologous stem cell transplantation (SCT);
- Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN),aspartate aminotransferase (AST) ≤2.5 ULN,ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L)
- No serious allergic constitution
- No other serous diseases that conflicts with the clinical program
- No other cancer history
- No serious mental disorder
- Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive
- Active hepatitis B or hepatitis C infection
- Recent or current use of glucocorticoid or other immunosuppressor
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases
- Transaminase >2.5 ULN, Bilirubin >3 ULN,Creatinine>1.25 ULN
- Participate in other clinical research in the past three months; previously treatment with any gene therapy products
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
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: VOGN-19
patienter vil modtage en prækonditionering med cyclophosphamid og fludarabin før infusion af CART-19-celler.
CART-19-cellerne skal administreres på dag 0, dag 1, dag 2.
|
patienter vil modtage et standard prækonditioneringsregime med cyclophosphamid 0,8-1,0 g/m2/dag
IV i 2 dage (dag-5 til dag-4).
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
safety as assessed by the occurrence of study related adverse events.
Tidsramme: 6 months
|
monitor the occurrence of study related adverse events.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
efficacy
Tidsramme: 2 years
|
anti-tumor activity of CART-19 cells will be determined in a follow-on study
|
2 years
|
duration of CART-19
Tidsramme: 2 years
|
Determine duration of in vivo survival of CART-19 cells.
|
2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Yongping Song, Henan Cancer Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Leukæmi
- Precursorcelle lymfoblastisk leukæmi-lymfom
- Leukæmi, lymfoid
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Cyclofosfamid
- Fludarabin
Andre undersøgelses-id-numre
- HenanCH080
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 .
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