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Lo studio clinico NCT07493135 per Mieloma Multiplo Recidivante/Refrattario è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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A Study of IMV102 in Patients With Relapsed/Refractory Multiple Myeloma Fase I, Fase II 30 Internazionale Escalation della dose Iniziato dallo sperimentatore

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07493135 è uno studio interventistico di Fase I Fase II volto a esaminare il trattamento per Mieloma Multiplo Recidivante/Refrattario, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 31 marzo 2026, con l'obiettivo di raggiungere 30 partecipanti. Sotto la guida di Suzhou Immunofoco Biotechnology Co., Ltd, dovrebbe concludersi entro il 1 aprile 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed/refractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after infusion for pharmacokinetic, pharmacodynamic, im...Mostra di più
Titolo ufficiale

A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed/Refractory Multiple Myeloma

Patologie
Mieloma Multiplo Recidivante/Refrattario
Altri ID dello studio
  • IMV102-CT02
Numero NCT
NCT07493135
Data di inizio (effettiva)
2026-03-31
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2028-04-01
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
Fase I
Fase II
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleIMV102 treatment group
IMV101 treatment
Eligible patients with relapsed/refractory multiple myeloma will receive an infusion of IMV102 injection, and the safety and efficacy of IMV102 injection will be evaluated within 24 months post-infusion.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma
Incidence of adverse events and its severity after IMV102 injection treatment
24 months post IMV102 infusion
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Assessment of pharmacokinetic (about Cmax)
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
24 months post IMV102 infusion
Assessment of pharmacokinetic (about Tmax)
The time to reach the maximum concentration (Tmax)
24 months post IMV102 infusion
Assessment of pharmacokinetic (about AUC0-28d)
The area under the CAR-T concentration versus time curve (AUC) for 28 days after IMV102 administration
From first dose of IMV102 to 28 days after IMV102 administration
Assessment of pharmacokinetic (about AUC0-90d)
The area under the CAR-T concentration versus time curve (AUC) for 90 days after IMV102 administration
From first dose of IMV102 to 90 days after IMV102 administration
Efficacy of IMV102 injection
Overall response rate after IMV102 infusion
about 2 years
Efficacy of IMV102 injection
Overall survival after IMV102 infusion
about 2 years
Efficacy of IMV102 injection
Progress-free survival after IMV102 infusion
about 2 years
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  1. Age: Aged 18 to 80 years (inclusive), of either sex.
  2. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  3. Diagnosed with relapsed/refractory multiple myeloma according to the IMWG criteria, who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent-based regimen).
  4. Reproductive Status: Subjects of childbearing potential and their partners must agree to use medically accepted highly effective contraceptive methods (e.g., intrauterine device, condom) from the time of signing the informed consent form until 12 months after the last dose. They must not donate germ cells, including sperm or oocytes, during this period.
  5. Informed Consent: Subjects must voluntarily sign and date a written informed consent form (ICF) indicating agreement to participate in this study.
  6. Compliance: Subjects must be willing and able to comply with the scheduled treatment plan, laboratory tests, follow-up, and other study requirements.

  1. Pregnancy/Lactation: Women who are pregnant or breastfeeding.
  2. Other Malignancies: Subjects with a prior or concurrent other malignancy.
  3. Infectious Diseases: Positive for human immunodeficiency virus (HIV) antibody; active hepatitis B virus infection (HBV-DNA > 10³ IU/mL); acute or chronic active hepatitis C (HCV antibody positive); positive syphilis antibody; cytomegalovirus (CMV) infection (IgM positive or DNA positive).
  4. Presence of clinically active uncontrolled infection based on assessment done by treating physicians.
  5. Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment.
  6. Allergies: History of other severe allergies such as anaphylactic shock; known severe allergic reaction to IMV102 or any of its components; known severe allergic reaction to tocilizumab.
  7. Psychiatric Disorders: Subjects with severe mental disorders.
  8. Transplant History: History of solid organ transplantation.
  9. Compliance: Subjects whom the investigator assesses as unable or unwilling to comply with the requirements of the study protocol.
  10. Other Conditions: Subjects with any other concurrent severe and/or uncontrolled medical conditions that, in the judgment of the investigator, make them unsuitable for participation in this study.
Suzhou Immunofoco Biotechnology Co., Ltd logoSuzhou Immunofoco Biotechnology Co., Ltd
Contatti principali dello studio
Contatto: Juan Du, MD, 15800706091, [email protected]
4 Centri dello studio in 1 paesi
Beijing GoBroad Boren Hospital, Beijing, China
Yajing Zhang, Contatto, 010-83605002, 18601333856, [email protected]
The second affiliated hospital of Chongqing medical university, Chongqing, China
Shifeng Lou, Contatto, 13508331213, [email protected]
Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Juan Du, Contatto, 15800706091, [email protected]
Zhengzhou Yihe Hospital, Zhengzhou, China
Li Wang, Contatto, 0371-56570666, 13603846919, [email protected]