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- Klinische proef NCT04887012
Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Werving
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
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Contact:
- Wenbing Qian
- Telefoonnummer: +8613605801032
- E-mail: qianwb@zju.edu.cn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Volunteer to participate in this study and sign an informed consent form;
- Age 18-75 years old, no gender limit;
Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:
- Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ;
- Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;
- Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;
- Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;
- At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
- The expected survival period is ≥12 weeks;
- The puncture section of the tumor tissue was positive for CD19 expression;
- ECOG score 0-2 points;
Sufficient organ function reserve:
- Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
- Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
- Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
- Glomerular filtration rate>50Ml/min
- Cardiac ejection fraction (EF) ≥50%;
- Under natural indoor air environment, basic oxygen saturation>92%
- Allow a previous stem cell transplantation
- The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;
- Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;
- Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial
- Two tests for the new coronavirus were negative.
Exclusion Criteria:
- Those who have a history of allergies to any of the ingredients in cell products;
- History of other tumors
- Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;
- Have received gene therapy in the past 3 months;
- Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;
- Hepatitis B (HBsAg positive, but HBV-DNA <103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including But not limited to people living with HIV;
According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV.
Impaired subjects;
- Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);
- Subjects with a history of epilepsy or other central nervous system diseases;
- Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;
- Have received any other drugs that target CD19;
- Women who are breastfeeding and unwilling to stop breastfeeding;
- Any other situation that the investigator believes may increase the risk of the subject or interfere with the results of the test.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: CAR-NK019
All subjects were intravenously administrated with CAR-NK019
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lentiviral vector-transducted HLA haploidentical NK cells to express anti-CD19 CAR
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Incidence of dose limiting toxicity (DLTs)
Tijdsspanne: Up to 28 days
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To evaluate the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma
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Up to 28 days
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The overall response rate(ORR)
Tijdsspanne: Up to 2 years
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To determine the anti-tumor effectivity of CAR-NK019
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Up to 2 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall survival (OS)
Tijdsspanne: Up to 2 years
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To determine the anti-tumor effectivity of CAR-NK019
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Up to 2 years
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progression free survival (PFS)
Tijdsspanne: Up to 2 years
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To determine the anti-tumor effectivity of CAR-NK019
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Up to 2 years
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Pharmacokinetics of CAR positive cells
Tijdsspanne: Up to 2 years
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The copy number of CAR DNA was measured at the preset follow-up time point.
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Up to 2 years
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Pharmacokinetics of CAR-NK cells
Tijdsspanne: Up to 2 years
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The duration of CAR-positive NK cells in circulation was measured by FACs
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Up to 2 years
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IR2021002168
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Estrella Biopharma, Inc.Eureka Therapeutics Inc.Nog niet aan het wervenLymfoom | Lymfoom, non-Hodgkin | Non-Hodgkin-lymfoom | Non-Hodgkin lymfoom | Refractair B-cel non-Hodgkin-lymfoom | Refractair non-Hodgkin-lymfoom | Hoogwaardig B-cellymfoom | CZS lymfoom | Lymfomen Non-Hodgkin B-cel | Recidiverend non-Hodgkin-lymfoom | Lymfoom, Non-Hodgkin | Groot B-cellymfoom | Lymfoom, non-Hodgkin... en andere voorwaarden
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City of Hope Medical CenterNational Cancer Institute (NCI)WervingRefractair B-cel non-Hodgkin-lymfoom | Recidiverend B-cel non-Hodgkin-lymfoom | Hoogwaardig B-cel non-Hodgkin-lymfoom | Intermediate graad B-cel non-Hodgkin-lymfoomVerenigde Staten
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Peking University Cancer Hospital & InstituteNanjing Legend Biotech Co.WervingEen onderzoek naar LUCAR-20SP bij proefpersonen met recidiverend/refractair B-cel non-HodgkinlymfoomRecidiverend B-cel non-Hodgkin-lymfoom | Refractair B-cel non-Hodgkin lymfoomChina
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National Cancer Institute (NCI)WervingRefractair B-cel non-Hodgkin-lymfoom | Refractair T-cel non-Hodgkin-lymfoom | Recidiverend B-cel non-Hodgkin-lymfoom | Terugkerend getransformeerd non-Hodgkin-lymfoom | Recidiverend non-Hodgkin-lymfoom | Refractair non-Hodgkin-lymfoom | Recidiverend T-cel non-Hodgkin-lymfoom | Recidiverend primair... en andere voorwaardenVerenigde Staten
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ADC Therapeutics S.A.WervingB-cel non-Hodgkin-lymfoom | Refractair B-cel non-Hodgkin-lymfoom | Recidiverend B-cel non-Hodgkin-lymfoomVerenigde Staten, Spanje, Italië, Verenigd Koninkrijk, België, Tsjechië
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CARsgen Therapeutics Co., Ltd.RenJi Hospital; First Affiliated Hospital of Zhejiang UniversityVoltooidRefractair B-cel non-Hodgkin-lymfoom | Recidiverend B-cel non-Hodgkin-lymfoomChina
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Affimed GmbHBeëindigdRefractair B-cel non-Hodgkin-lymfoom | Recidiverend B-cel non-Hodgkin-lymfoomVerenigde Staten, Tsjechië, Duitsland, Polen
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Mayo ClinicWervingIndolent B-cel non-Hodgkin-lymfoom | Recidiverend indolent non-hodgkinlymfoom | Refractair indolent non-hodgkinlymfoom | Recidiverend indolent B-cel non-Hodgkin lymfoom | Refractair indolent B-cel non-Hodgkin lymfoomVerenigde Staten
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Klinische onderzoeken op anti-CD19 CAR-NK
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Allife Medical Science and Technology Co., Ltd.OnbekendRefractair B-cellymfoom
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Allife Medical Science and Technology Co., Ltd.Peking University Cancer Hospital & InstituteOnbekendRefractair B-cellymfoom
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Second Affiliated Hospital, School of Medicine,...Werving
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Second Affiliated Hospital, School of Medicine,...Nog niet aan het wervenMantelcellymfoom (MCL) | Primair mediastinaal B-cellymfoom (PMBCL) | Diffuus groot B-cellymfoom (DLBCL)
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Xuzhou Medical UniversityWervingB-cel lymfoom | Acute lymfatische leukemie | Chronische lymfatische leukemieChina
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YANRU WANGRui Therapeutics Co., LtdWerving
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Second Affiliated Hospital, School of Medicine,...Nog niet aan het wervenSystemische lupus erythematosusChina
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Changhai HospitalNanjing Enricnk Biotech Co., LtdWervingDiffuus grootcellig B-cellymfoomChina
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Changzhou No.2 People's HospitalRui Therapeutics Co., LtdNog niet aan het wervenTrombocytopenie Allo-immuun