Dose-Escalation/Expansion Study of iMagic in Relapsed/Refractory Hematologic Malignancies
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Immunofoco Biotechnology Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
18~80 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
With evaluable tumor lesion.
Disqualifiers
Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy.
Prior antitumor therapy with insufficient washout period.
Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
Lactating women.
Trial design
Design model
Parallel
Treatments tested in this trial
iMagic Injection (IMV101)
Biological/VaccineEligible 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.
iMagic Injection (IMV102)
Biological/VaccineEligible 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: iMagic Injection (IMV101) treatment groupExperimental treatment 1 intervention
Group B: iMagic Injection (IMV102) treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of iMagic injection in patients with relapsed/refractory hematologic malignancies
Incidence of adverse events and its severity after iMagic injection treatment
Time frame
24 months post iMagic injection infusionSecondary outcomes
1
Assessment of pharmacokinetic (about Cmax)
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
Time frame
24 months post iMagic injection infusion2
Assessment of pharmacokinetic (about Tmax)
The time to reach the maximum concentration (Tmax)
Time frame
24 months post iMagic injection infusion3
Efficacy of iMagic injection
Overall response rate after iMagic injection infusion
Time frame
about 2 years4
Efficacy of iMagic injection
Progress-free survival after iMagic injection infusion
Time frame
about 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: