Dose-Escalation/Expansion Study of iMagic in Relapsed/Refractory Hematologic Malignancies
A Dose-Escalation and Dose-Expansion Study of iMagic Injection in Participants With Relapsed/Refractory Hematologic Malignancies
1 other identifier
interventional
30
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2026
CompletedFirst Posted
Study publicly available on registry
September 3, 2026
CompletedStudy Start
First participant enrolled
September 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 10, 2028
September 8, 2026
August 1, 2026
1 year
August 31, 2026
September 2, 2026
Conditions
Outcome Measures
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
24 months post iMagic injection infusion
Secondary Outcomes (5)
Assessment of pharmacokinetic (about Cmax)
24 months post iMagic injection infusion
Assessment of pharmacokinetic (about Tmax)
24 months post iMagic injection infusion
Efficacy of iMagic injection
about 2 years
Efficacy of iMagic injection
about 2 years
Efficacy of iMagic injection
about 2 years
Study Arms (2)
iMagic Injection (IMV101) treatment group
EXPERIMENTALiMagic Injection (IMV101) for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma
iMagic Injection (IMV102) treatment group
EXPERIMENTALiMagic Injection (IMV102) for the Treatment of Relapsed/Refractory Multiple Myeloma
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- \~80 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- With evaluable tumor lesion.
- Relapsed and/or refractory hematologic malignancies (Non-Hodgkin Lymphoma or Multiple Myeloma).
- Life expectancy≥ 3 months.
- Clinical laboratory values meet screening visit criteria.
- Adequate organ function.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2026
First Posted
September 3, 2026
Study Start
September 10, 2026
Primary Completion (Estimated)
September 10, 2027
Study Completion (Estimated)
September 10, 2028
Last Updated
September 8, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share