Relapsed/Refractory Hematologic MalignanciesEarly Phase 1NCT07802756
Dose-Escalation/Expansion Study of iMagic in Relapsed/Refractory Hematologic Malignancies
A Early Phase 1 study testing iMagic Injection (IMV101) and iMagic Injection (IMV102) in people with Relapsed/Refractory Hematologic Malignancies, run by Suzhou Immunofoco Biotechnology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapsed/Refractory Hematologic Malignancies
- What is being tested?
- iMagic Injection (IMV101) and iMagic Injection (IMV102)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2026to 10 Sep 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Ning Li, +86-010-87787213, lining@cicams.ac.cn
About this study
Official title: 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.
- Being tested
- iMagic Injection (IMV101), iMagic Injection (IMV102)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| iMagic Injection (IMV101) treatment group | Experimental | iMagic Injection (IMV101) for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma Receives: Biological: iMagic Injection (IMV101) |
| iMagic Injection (IMV102) treatment group | Experimental | iMagic Injection (IMV102) for the Treatment of Relapsed/Refractory Multiple Myeloma Receives: Biological: iMagic Injection (IMV102) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months post iMagic injection infusion
Secondary outcomes (5)
Assessment of pharmacokinetic (about Cmax)
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
Measured: 24 months post iMagic injection infusion
Assessment of pharmacokinetic (about Tmax)
The time to reach the maximum concentration (Tmax)
Measured: 24 months post iMagic injection infusion
Efficacy of iMagic injection
Overall response rate after iMagic injection infusion
Measured: about 2 years
Efficacy of iMagic injection
Progress-free survival after iMagic injection infusion
Measured: about 2 years
Efficacy of iMagic injection
Overall survival after iMagic injection infusion
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start10 Dec 2026 (estimated)
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802756
- Sponsor's protocol ID
- iMagic-CT01
- Status last verified
- Nov 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation and Dose-Expansion Study of iMagic Injection in Participants With Relapsed/Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07802756
- Acronym / sponsor ID
- iMagic-CT01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suzhou Immunofoco Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2026 (estimated)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | iMagic Injection (IMV101) treatment group |
| 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. | Biological | iMagic Injection (IMV102) treatment group |
Primary outcome
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
5 secondary outcomes
Assessment of pharmacokinetic (about Cmax)
Time frame: 24 months post iMagic injection infusion
Assessment of pharmacokinetic (about Tmax)
Time frame: 24 months post iMagic injection infusion
Efficacy of iMagic injection
Time frame: about 2 years
Efficacy of iMagic injection
Time frame: about 2 years
Efficacy of iMagic injection
Time frame: about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing iMagic Injection (IMV101) and iMagic Injection (IMV102) in people with Relapsed/Refractory Hematologic Malignancies, run by Suzhou Immunofoco Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li (+86-010-87787213, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.