CClinicalTrials.gg
Sign In
Not yet recruitingNCT07802756Updated Sep 8, 2026

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

An Early Phase 1 interventional study of iMagic Injection (IMV101) and iMagic Injection (IMV102) in Relapsed/Refractory Hematologic Malignancies, sponsored by Suzhou Immunofoco Biotechnology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Suzhou Immunofoco Biotechnology Co., Ltd · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed/Refractory Hematologic Malignancies
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    iMagic Injection (IMV101) treatment group

    iMagic Injection (IMV101) for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma

    Biological: iMagic Injection (IMV101)

  • Experimental
    iMagic Injection (IMV102) treatment group

    iMagic Injection (IMV102) for the Treatment of Relapsed/Refractory Multiple Myeloma

    Biological: iMagic Injection (IMV102)

Interventions

  • BiologicaliMagic 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.

  • BiologicaliMagic 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.

05

What researchers measure

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 infusion

Secondary 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 infusion

  2. Assessment of pharmacokinetic (about Tmax)

    The time to reach the maximum concentration (Tmax)

    Time frame: 24 months post iMagic injection infusion

  3. Efficacy of iMagic injection

    Overall response rate after iMagic injection infusion

    Time frame: about 2 years

  4. Efficacy of iMagic injection

    Progress-free survival after iMagic injection infusion

    Time frame: about 2 years

  5. Efficacy of iMagic injection

    Overall survival after iMagic injection infusion

    Time frame: about 2 years

06

Study locations

1 site
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07802756
Lead sponsor
Suzhou Immunofoco Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 10, 2027 (estimated)
Completion
Sep 10, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Ning Li
Contact
lining@cicams.ac.cn
+86-010-87787213

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hematologic Neoplasms→

Other studies from this sponsor

Suzhou Immunofoco Biotechnology Co., Ltd

Start the discussion