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

NCT07802756 — Early Phase 1, Not yet recruiting, 30 participants, Suzhou Immunofoco Biotechnology Co., Ltd

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

Registry	NCT07802756
Status	Not yet recruiting
Phase	Early Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Suzhou Immunofoco Biotechnology Co., Ltd (Industry)
Conditions	Relapsed/Refractory Hematologic Malignancies
Interventions	iMagic Injection (IMV101), iMagic Injection (IMV102) (Biological)
Dates	start 2026-09-10 (estimated), primary completion 2027-09-10 (estimated), completion 2028-09-10 (estimated), first posted 2026-09-03, last updated 2026-09-08
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
iMagic Injection (IMV101) treatment group	Experimental	Biological: iMagic Injection (IMV101)	iMagic Injection (IMV101) for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma
iMagic Injection (IMV102) treatment group	Experimental	Biological: iMagic Injection (IMV102)	iMagic Injection (IMV102) for the Treatment of Relapsed/Refractory Multiple Myeloma

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.

+Outcome measures

Primary outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of iMagic injection in patients with relapsed/refractory hematologic malignancies [24 months post iMagic injection infusion]: Incidence of adverse events and its severity after iMagic injection treatment

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	China