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Not yet recruitingNCT07802756Updated Nov 4, 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 2026-11-04.

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

Updated Nov 4, 2026Start date movedPrimary completion movedGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 148 studies in Hematologic Neoplasms with a site in China — 75 open to participants now, 83 under way, 8 of them phase 3. Hematologic Neoplasms · China.

Planned enrollment
83rd of 123
30 · median 56
Started
2026
with 19 others
Phase 1
57 of 148
30 open now
Primary completion
2027-12
later than 54 of 82 live
Registered
148th of 148
by date

Among the 148 studies in Hematologic Neoplasms with a site in China, this one is the 83rd largest by planned enrollment of the 123 interventional ones that give a count, is one of 20 that started in 2026, is one of 57 in phase 1, reaches primary completion later than 54 of the 82 other live ones, and was the 148th registered.

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

Browse Hematologic Neoplasms studies →

Open to participants now

75 of the 148 studies in Hematologic Neoplasms with a site in China are open now. Recruiting first, the newest first:

70 more — sign in →

All 75 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

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.

03

Conditions studied

  • Relapsed/Refractory Hematologic Malignancies
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants voluntarily participate in clinical studies; Fully informed of this study and signed ; 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. (ECOG) performance status of 0 or 1.
  4. With evaluable tumor lesion.
  5. hematologic (Non-Hodgkin Lymphoma or Multiple Myeloma).
  6. ≥ 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 .
  3. Known life-threatening allergic reaction, reaction, or intolerance to study drug 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 to prevent anaphylaxis as assessed by the investigator).
  4. Lactating women.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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.

06

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 95 industry-sponsored phase 1 interventional studies under Hematologic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 78. This study's planned 12 months is below that.

Counting every sponsor, half of 159 studies reached it within 51 months; a quarter within 28 and three quarters within 78.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Sep 2026 → Dec 2026 and primary completion Sep 2027 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 3, 2026
StartEst.
Dec 10, 2026was Sep 2026
Primary completionEst.
Dec 10, 2027was Sep 2027
CompletionEst.
Sep 10, 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 10, 2026→Dec 10, 2026
Nov 4, 2026
Primary completion
Sep 10, 2027→Dec 10, 2027
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Start date Sep 10, 2026→Dec 10, 2026
    Primary completion Sep 10, 2027→Dec 10, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07802756
Lead sponsor
Suzhou Immunofoco Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Dec 10, 2026 (estimated)
Primary completion
Dec 10, 2027 (estimated)
Completion
Sep 10, 2028 (estimated)
Last update
Nov 4, 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 Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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