National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
NCT Number: NCT07802756
This is an investigator-initiated, single-center, dose-escalation and dose-expansion early-phase clinical study to evaluate the safety and efficacy of iMagic Injection in participants with hematologic malignancies. The study consists of two cohorts: Cohort 1 enrolls participants with relapsed/refractory B-cell non-Hodgkin lymphoma, and Cohort 2 enrolls participants with relapsed/refractory multiple myeloma. Eligible participants in each cohort will receive infusions of iMagic Injection (IMV101 for lymphoma, IMV102 for myeloma). Blood and urine samples will be collected from participants before and after infusion for assessment of pharmacokinetics, pharmacodynamics, immunogenicity, safety, and other relevant evaluations.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Early Phase 1
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eligible patients with relapsed/refractory non-Hodgkin lymphoma will receive an infusion of iMagic Injection (IMV101) , and the safety and efficacy ofiMagic Injection (IMV101) will be evaluated within 24 months post-infusion.
Eligible patients with relapsed/refractory multiple myeloma will receive an infusion of iMagic Injection (IMV102) , and the safety and efficacy of iMagic Injection (IMV102) will be evaluated within 24 months post-infusion.
Time frame: 24 months post iMagic injection infusion
Incidence of adverse events and its severity after iMagic injection treatment
Time frame: 24 months post iMagic injection infusion
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
Time frame: 24 months post iMagic injection infusion
The time to reach the maximum concentration (Tmax)
Time frame: about 2 years
Overall response rate after iMagic injection infusion
Time frame: about 2 years
Progress-free survival after iMagic injection infusion
Time frame: about 2 years
Overall survival after iMagic injection infusion
Contact information is provided by the study sponsor or research team.
Suzhou Immunofoco Biotechnology Co., Ltd
Industry
A Dose-Escalation and Dose-Expansion Study of iMagic Injection in Participants With Relapsed/Refractory Hematologic Malignancies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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