Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iMagic Injection (IMV101) | Biological | — | UNRESOLVED |
| iMagic Injection (IMV102) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- iMagic Injection (IMV101) treatment group
- description
- iMagic Injection (IMV101) for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma
- interventionNames
- Biological: iMagic Injection (IMV101)
- type
- EXPERIMENTAL
- label
- iMagic Injection (IMV102) treatment group
- description
- iMagic Injection (IMV102) for the Treatment of Relapsed/Refractory Multiple Myeloma
- interventionNames
- Biological: iMagic Injection (IMV102)
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of iMagic injection in patients with relapsed/refractory hematologic malignancies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. 18\~80 years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. With evaluable tumor lesion. 5. Relapsed and/or refractory hematologic malignancies (Non-Hodgkin Lymphoma or Multiple Myeloma). 6. Life expectancy≥ 3 months. 7. Clinical laboratory values meet screening visit criteria. 8. Adequate organ function. Exclusion Criteria: 1. Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy. 2. Prior antitumor therapy with insufficient washout period. 3. 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). 4. Lactating women.
References
Publications (0)
Data not yet available