Dose-Escalation/Expansion Study of iMagic in Relapsed/Refractory Hematologic Malignancies

August 31, 2026 updated by: Suzhou Immunofoco Biotechnology Co., Ltd

A Dose-Escalation and Dose-Expansion Study of iMagic Injection in Participants With Relapsed/Refractory Hematologic Malignancies

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iMagic Injection (IMV101) treatment group
iMagic Injection (IMV101) for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma
Biological: iMagic Injection (IMV101)
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.
Experimental: iMagic Injection (IMV102) treatment group
iMagic Injection (IMV102) for the Treatment of Relapsed/Refractory Multiple Myeloma
Biological: iMagic Injection (IMV102)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of iMagic injection in patients with relapsed/refractory hematologic malignancies
Time Frame: 24 months post iMagic injection infusion
Incidence of adverse events and its severity after iMagic injection treatment
24 months post iMagic injection infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pharmacokinetic (about Cmax)
Time Frame: 24 months post iMagic injection infusion
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
24 months post iMagic injection infusion
Assessment of pharmacokinetic (about Tmax)
Time Frame: 24 months post iMagic injection infusion
The time to reach the maximum concentration (Tmax)
24 months post iMagic injection infusion
Efficacy of iMagic injection
Time Frame: about 2 years
Overall response rate after iMagic injection infusion
about 2 years
Efficacy of iMagic injection
Time Frame: about 2 years
Progress-free survival after iMagic injection infusion
about 2 years
Efficacy of iMagic injection
Time Frame: about 2 years
Overall survival after iMagic injection infusion
about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Immunofoco Biotechnology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

September 10, 2028

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iMagic-CT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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