- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07617285
Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML
A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed/Refractory Acute Myeloid Leukemia
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Xiangyu Zhao, M.D,Ph.D
- Numero di telefono: 010-88325531
- Email: Zhao_xy@bjmu.edu.cn
Backup dei contatti dello studio
- Nome: Meng Lv, M.D., Ph.D
- Numero di telefono: 010-88316617
- Email: drlvmeng@bjmu.edu.cn
Luoghi di studio
-
-
-
Beijing, Cina, 100044
- Reclutamento
- Peking University People's Hospital
-
Sub-investigatore:
- Meng Lv, M.D, Ph.D
-
Contatto:
- Meng Lv, M.D,Ph.D
- Numero di telefono: 010-88316617
- Email: drlvmeng@bjmu.edu.cn
-
Investigatore principale:
- Xiangyu Zhao, M.D, Ph.D
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Age 18-70 years (inclusive), male or female.
- Relapsed or refractory acute myeloid leukemia (R/R AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.
- Bone marrow blasts ≥5% by morphology.
- Estimated life expectancy >12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Adequate organ function without ongoing supportive care, defined as:
- Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
- Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;
- Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
- Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.
c) Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula); d) Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.
Exclusion Criteria:
- Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;
- Participants with a history of epilepsy or other central nervous system disease;
- Participants who have previously received autologous or allogeneic CAR-T therapy;
- Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
- Participants who have received prior immunotherapy targeting NKG2DL;
- Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;
- Participant has any of the following at screening:
1)Active, uncontrolled systemic infection or requiring intravenous anti-infective agents 2)Any of the following cardiac conditions, including:
- New York Heart Association Class III-IV heart failure;
- History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;
- History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
- History of severe nonischemic ardiomyopathy;
- Other cardiac disease that the investigatorbelieve could jeopardize the participant 's well-being or compromise participation in this clinical trial; 3) Active bleeding of clinical significance as judged by the investigator; 4)Requiring supplemental oxygen to maintain oxygen saturation> 92%; 5)Patients with severe chronic obstructive pulmonary disease (COPD) or other lung diseases that cannot tolerate CAR-T treatment as judged by the investigator;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: CAR-T cells chimeric antigen receptor T cells
CT0890B cells infusion
|
Conditioning regimen: Days -9 to -3: Venetoclax administered with a target dose of 200 mg/day. Days -5 to -4: Cytarabine administered at 500 mg/m²/day. Days -5 to -3: Cyclophosphamide at 300 mg/m²/day plus Fludarabine at 30 mg/m²/day. Day 0: Infusion of CT0890B CAR-T cells at one of four dose levels using an i3+3 Dose-Escalation Design: 1.5 × 10⁸ total cells, 3.0 × 10⁸ total cells, 4.5 × 10⁸ total cells, 6.0 × 10⁸ total cells
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adverse Events (AE) after CT0890B infusion
Lasso di tempo: 12 months after CT890B infusion
|
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
|
12 months after CT890B infusion
|
|
Dose-limiting toxicity (DLT)
Lasso di tempo: Up to 28 days after CAR-T cells infusion
|
The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0890B that meet the criteria for DLT events after the first infusion
|
Up to 28 days after CAR-T cells infusion
|
|
MTD and/or dose range
Lasso di tempo: Up to 28 days after CAR-T cells infusion
|
Evaluate Dose limited toxicity and recommended dosage range after CT0890B infusion
|
Up to 28 days after CAR-T cells infusion
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Composite response (CRc)
Lasso di tempo: 12 months after CT0890B infusion
|
The composite response rate (CRc) included complete response (CR), complete response with partial hematologic recovery (CRh), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS).
Responses were assessed in accordance with the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet criteria for acute myeloid leukemia (AML).
|
12 months after CT0890B infusion
|
|
Partial response (PR)
Lasso di tempo: 12 months after CT0890B infusion
|
Partial response (PR) was defined and assessed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet response criteria for AML.
|
12 months after CT0890B infusion
|
|
Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy
Lasso di tempo: 12 months after CT0890B infusion
|
This secondary endpoint was defined as the proportion of patients who proceeded to stem cell transplantation after CAR-T therapy during the study period.
|
12 months after CT0890B infusion
|
|
Duration of response (DOR)
Lasso di tempo: 12 months after CT0890B infusion
|
Patients achieving CR, CRi, CRh, or MLFS were included in the duration of response (DOR) analysis set.
DOR was defined as the time from the date of first documented response to the date of disease relapse or death from any cause, whichever occurred first.
|
12 months after CT0890B infusion
|
|
Event-free survival (EFS)
Lasso di tempo: 12 months after CT0890B infusion
|
EFS was defined as the time from the date of CAR-T infusion to the earliest occurrence of treatment failure, relapse, or death from any cause. Treatment failure was defined as failure to achieve CR, CRh, CRi, MLFS, or PR at both prespecified efficacy assessments. Relapse included hematologic or extramedullary relapse after achieving CR, CRh, CRi or MLFS. For patients with treatment failure (ineffective therapy), the primary EFS analysis assigned an event time of 1 day (i.e., the time from infusion to treatment receipt). Sensitivity analyses were performed using alternative definitions of event timing, including the actual date of treatment failure, the end of treatment, or the initiation of subsequent anti-leukemia therapy. |
12 months after CT0890B infusion
|
|
Overall survival (OS)
Lasso di tempo: 12 months after CT0890B infusion
|
OS is defined as the time from the date of receiving the infusion to the date of death from any cause.
|
12 months after CT0890B infusion
|
|
Minimal Residual Disease (MRD) Negativity Rate
Lasso di tempo: 12 months after CT0890B infusion
|
MRD negativity rate was assessed in participants who achieved CR, CRh, CRi or MLFS.
MRD negativity was defined as <0.01%
abnormal cells among CD45-positive cells as determined by multiparameter flow cytometry (MFC).
|
12 months after CT0890B infusion
|
|
Pharmacokinetic Endpoint - Peak expansion (Cmax)
Lasso di tempo: 12 months after CT0890B infusion
|
The maximum concentration or peak value of CT0890B cells in plasma after infusion, measured by CAR copy number.
|
12 months after CT0890B infusion
|
|
Time to peak expansion (Tmax) of CT0890B
Lasso di tempo: 12 months after CT0890B infusion
|
The time required to reach the peak expansion (maximum CAR copy number) in plasma following the infusion of CT0890B cells.
|
12 months after CT0890B infusion
|
|
Area under the curve (AUC) of CT0890B
Lasso di tempo: 12 months after CT0890B infusion
|
The total cellular exposure in plasma after infusion, calculated based on the area under the CAR copy number-time curve.
|
12 months after CT0890B infusion
|
|
In vivo persistence of CT0890B
Lasso di tempo: Up to 12 months after CT0890B infusion
|
The duration for which CT0890B cells remain detectable in the plasma after infusion, monitored via CAR copy number.
|
Up to 12 months after CT0890B infusion
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: XiangYu Zhao, M.D, Ph.D, Peking University People's Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CT0890B-CG8001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Antiriciclaggio
-
Rigshospitalet, DenmarkReclutamento
-
Tongji HospitalNon ancora reclutamento
-
Merck Sharp & Dohme LLCTerminatoDLBCL | AML Compreso AML de Novo e AML secondario a MDS
-
Rubius TherapeuticsTerminato
-
Ruijin HospitalReclutamentoP53 Mutazione | Malignità mieloide | MDS | AmlCina
-
Peking University People's HospitalReclutamentoLeucemia mieloide acuta (AML) | Leucemia mieloide acuta recidivante/refrattaria (AML) | Leucemia mieloide acuta ad alto rischio (AML)Cina
-
Eisai Inc.TerminatoLeucemia mieloide acuta pediatrica (AML)Stati Uniti, Canada, Australia
-
AstraZenecaTerminatoLeucemia mieloide acuta recidivante o refrattaria (AML)Stati Uniti
-
Fujian Medical UniversityReclutamento
-
Institute of Hematology and Blood Transfusion,...Proton Therapy Center Czech s.r.o.ReclutamentoLeucemia mieloide acuta (AML) | Terapia protonica | MDS e AML prima di SCT allogenico | Neoplasia mielodisplastica | Sindrome mielodisplastica (MDS)/AMLCechia
Prove cliniche su CAR-T cells chimeric antigen receptor T cells
-
Beijing Immunochina Medical Science & Technology...Peking University Cancer Hospital & InstituteNon ancora reclutamentoAdenocarcinoma della giunzione esofagogastrica | Adenocarcinoma GastricoCina
-
Zhejiang UniversityReclutamentoNeoplasie | Malattie ematologicheCina
-
National Cancer Institute (NCI)TerminatoLinfoma, cellule B | Leucemia linfatica cronica | Linfoma, non hodgkin | Leucemia linfocitica cronica a cellule BStati Uniti
-
National Cancer Institute (NCI)CompletatoLinfoma, cellule B | Linfoma, non hodgkinStati Uniti
-
National Cancer Institute (NCI)National Institutes of Health Clinical Center (CC)TerminatoCancro metastatico | Melanoma metastaticoStati Uniti
-
City of Hope Medical CenterNational Cancer Institute (NCI)ReclutamentoAstrocitoma ricorrente, mutante IDH, grado 4 | Glioblastoma ricorrente, IDH-WildtypeStati Uniti
-
National Cancer Institute (NCI)Attivo, non reclutanteMieloma multiplo | Mieloma, plasmacelluleStati Uniti
-
Mayo ClinicNational Cancer Institute (NCI)ReclutamentoMieloma multiplo refrattario | Mieloma multiplo ricorrenteStati Uniti
-
Ohio State University Comprehensive Cancer CenterReclutamentoLeucemia linfocitica cronica refrattaria | Linfoma non Hodgkin ricorrente | Linfoma non Hodgkin refrattario | Leucemia linfoblastica acuta ricorrente | Leucemia linfoblastica acuta refrattaria | Leucemia linfocitica cronica ricorrente | Linfoma linfoblastico refrattario | Leucemia linfocitica cronica... e altre condizioniStati Uniti