- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04617704
BCMA and CD19 Targeted Fast Dual CART for Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
21 september 2021 uppdaterad av: Weijun Fu, Shanghai Changzheng Hospital
Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma
This is a single arm, open label, multi-center prospective study to explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(MM).
Studieöversikt
Detaljerad beskrivning
The main aim of this study is to determin the safety and efficacy of GC012F in cytogenetic high-risk MM.
GC012F is an autologus dual chimeric antigen receptor T-cell(CAR-T) therapy that targets B-cell maturation antigen(BCMA) and CD19.
This study comprises of a screening phase(less than or equal to 28 days prior to apheresis) followed by apheresis(will occur upon enroiiment); Treatment Phase including autologus stem cell transplant on Day-1 followed by infusion of GC012F on Day0 and then post-infusion assessments from Day1 to Day 84; and a Post-treatment Phase(Day 85 and up to end of the study).
Efficacy will be explored to assessed and safety will be closely monitored during the study.
Studietyp
Interventionell
Inskrivning (Förväntat)
15
Fas
- Tidig fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Weijun Fu
- Telefonnummer: +8613816052522 +8613816052522
- E-post: fuweijun2010@hotmail.com
Studieorter
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Shanghai
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Shanghai, Shanghai, Kina
- Shanghai Changzheng Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Diagnosis of active MM as defined by any of following: a) serum M protein more than or equal to 10g/dL; b) urine M protein more than or equal to 200mg/24 h; c) involved serum free light chain more than or equal to 100mg/dL with abnormal serum kappa lambda ratio;
- Patients with clear BCMA expression(percent of BCMA positive plasma cells more than or equal to 20%) detected by flow cytometry;
- High-risk chromosomal abnormal defined as presence of del17p, and/or t(4;14) and/or t(14;16);
- Estimated life expectancy more than or equal to 3 months;
- Absolute neutrophil count more than or equal to 1*10^9/L;
- Platelet count more than or equal to 25*10^9/L;
- Absolute lymphocyte count more than or equal to 1*10^8/L;
- Liver, kidney and cardiopulmonary functions meet the following requirements: a) Total bilirubin less than or equal to 2*ULN(except for Gilbert Syndrome); ALT and AST less than or equal to 2.5*ULN, maintenance of kidney function not depend on dialysis; c)Corrected serum calcium less than or equal to 12.5 mg/dL or free ion calcium less than or equal to 6.5mg/dL(1.6mmol/L);
- Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
- Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 1 year after CAR-T infusion;
- subjects must have signed writtern informed consent.
Exclusion Criteria:
- Accompanied by other unctrolled maligancies. Two exceptions to this criteria: Recepted radical therapy carcinoma without activity within 3 years before screening; fully treated skin non-melanoma;
- Any situations not benefit for subjects to accept or tolerated to planned therapy or understand informed consent; or any situation in which investigators believe that participation in this study is not in the subject's best intreat(eg., harm to health), or any situation that may prevent, limit or confuse the assessment;
- Convulsion or stoke within past 6 months;
- Any instability or systemic disease within 6 months prior to screening, including but not limited to congestive heart failure(New York heart association classification ≥ III), unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction, LEVF<50%(assessed by an echocardiogram or multi-door circuit scan);
- Patients have central nervous system(CNS) metastases or CNS involvement(including cranial neuropathies or mass lesions and leptomeningeal disease);
- Subjects with positive HBsAg or HBcAb positive and peripheal blood HBV-DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; syphilis primary screening antibody positive;
- Presence or suspicious of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
- Activity of autoimmune disease (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), orhistory of autoimmune disease within the last 3 years;
- Clinical evidence of dementia or changes of mental state;
- Exist of pulmonary fibrosis;
- Allergy subjects or history of severe hypersensitivity;
- Oxgen inhalation requirement to maintain adequate oxygen saturation;
- Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis, during or 2 weeks after CAR-T infusion;
- Patients who are accounted to be not appropriate for this investigator.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Experimental:GC012F treatment
BCMA+ cytogenetic high-risk multiple myeloma patients be treated with a single dose of GC012F cells.
Total dose of (1-5)*10^5/kg cells will be administered at Day 0
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GC012F injection is a autologous dual CAR-T targeted BCMA and CD19.
A single infusion of CAR-T cells will be administered intravenously.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Incidence and severity of adverse events after GC012F injection
Tidsram: Minimum 2 years after GC012F infusion
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Minimum 2 years after GC012F infusion
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of MRD negative patients after GC012F infusion
Tidsram: Minimum 2 years after GC012F infusion
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Minimum 2 years after GC012F infusion
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ORR(PR, VGPR, CR and sCR) of patients after GC012F treatment
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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percent of subjects who achieving PR or better after GC012F infusion
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Minimum 2 years after GC012F infusion(Day0)
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Progression free survival after GC012F treatment
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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Minimum 2 years after GC012F infusion(Day0)
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Duration of response of subjects after GC012F treatment
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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Minimum 2 years after GC012F infusion(Day0)
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Overall survivalof subjects after GC012F treatment
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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Minimum 2 years after GC012F infusion(Day0)
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Cytokines in serum after GC012F infusion
Tidsram: Minimum 24 weeks after GC012F infusion(Day0)
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Minimum 24 weeks after GC012F infusion(Day0)
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Subset of lymphocytes in blood after GC012F infusion
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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Minimum 2 years after GC012F infusion(Day0)
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Anti-GC012F antibodies in blood after GC012F infusion
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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Minimum 2 years after GC012F infusion(Day0)
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Cell counts of GC012F in blood and bone marrow(if available) after GC012F infusion
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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Minimum 2 years after GC012F infusion(Day0)
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Copies of GC012F in blood and bone marrow(if available) after GC012F infusion
Tidsram: Minimum 2 years after GC012F infusion(Day0)
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Minimum 2 years after GC012F infusion(Day0)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 december 2021
Primärt slutförande (Förväntat)
31 december 2021
Avslutad studie (Förväntat)
1 februari 2022
Studieregistreringsdatum
Först inskickad
20 augusti 2020
Först inskickad som uppfyllde QC-kriterierna
30 oktober 2020
Första postat (Faktisk)
5 november 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 september 2021
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Hematologiska sjukdomar
- Hemorragiska störningar
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Multipelt myelom
- Neoplasmer, Plasmacell
Andra studie-ID-nummer
- GBF003
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Obeslutsam
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Multipelt myelom
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University och andra samarbetspartnersAktiv, inte rekryterandeMultipelt myelom vid återfall | Multipelt myelom med misslyckad remission | Multipelt myelom stadium I | Multipelt myelomprogression | Multipelt myelom steg II | Multipelt myelom steg IIIKanada
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)AvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)AvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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Mayo ClinicAvslutadMultipelt myelom | Steg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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National Cancer Institute (NCI)AvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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National Cancer Institute (NCI)AvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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City of Hope Medical CenterAvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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University of WashingtonNational Cancer Institute (NCI)AvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)AvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)AvslutadSteg I multipelt myelom | Steg II multipelt myelom | Steg III multipelt myelom | Refraktärt multipelt myelomFörenta staterna
Kliniska prövningar på GC012F injection
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Gracell Biopharmaceuticals, Inc.RekryteringÅterfall/refraktärt multipelt myelomFörenta staterna
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Gracell Biotechnologies Ltd.RekryteringMultipelt myelomKina
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Shanghai Changzheng HospitalGracell Biotechnology Shanghai Co., Ltd.Rekrytering
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Shanghai Changzheng HospitalGracell Biotechnology Shanghai Co., Ltd.Rekrytering
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Shanghai Changzheng HospitalGracell Biotechnology Shanghai Co., Ltd.Rekrytering
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RenJi HospitalGracell Biotechnology Shanghai Co., Ltd.Rekrytering
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Zhejiang UniversityGracell Biotechnology Shanghai Co., Ltd.Rekrytering
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Shanghai Changzheng HospitalGracell Biotechnology Shanghai Co., Ltd.Rekrytering
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Jiangsu HengRui Medicine Co., Ltd.Har inte rekryterat ännu
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Bio-Thera SolutionsAvslutad