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NCT Number: NCT07802756

Dose-Escalation/Expansion Study of iMagic in 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

iMagic Injection (IMV101)

Biological

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.

iMagic Injection (IMV102)

Biological

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.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 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

Secondary outcomes

  1. 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)

  2. Assessment of pharmacokinetic (about Tmax)

    Time frame: 24 months post iMagic injection infusion

    The time to reach the maximum concentration (Tmax)

  3. Efficacy of iMagic injection

    Time frame: about 2 years

    Overall response rate after iMagic injection infusion

  4. Efficacy of iMagic injection

    Time frame: about 2 years

    Progress-free survival after iMagic injection infusion

  5. Efficacy of iMagic injection

    Time frame: about 2 years

    Overall survival after iMagic injection infusion

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Immunofoco Biotechnology Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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