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Acute Myeloid Leukemia (AML)Early Phase 1NCT06760260

Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia

A Early Phase 1 study testing Human Derived anti-CI135 CAR-T Injection in people with Acute Myeloid Leukemia (AML), run by Hrain Biotechnology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Human Derived anti-CI135 CAR-T Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteChina
Study dates
26 Jan 2022to 31 Dec 2026
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria to be enrolled:
  • Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;
  • Aged from 18 to 70 years (including cut-off value), Male and female;
  • Expected survival > 12 weeks;
  • Previously diagnosed as Acute Myeloid Leukemia by ELN updated criteria (2017) and one of the following indicators that is satisfied:
  • AML patients who have not achieved complete remission (CR) after at least three cycles of standard induction therapy, or
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  • AML patients who achieved complete remission after induction therapy but relapsed within one year, or
  • AML patients who achieved complete remission after induction therapy for more than one year but did not achieve remission after one cycle of chemotherapy with the original regimen following relapse, or
  • AML patients who relapsed after transplantation, or
  • AML patients who experienced two or more relapses. Note: For patients meeting conditions a), b), or c) with FLT3 mutations, they must have undergone at least one treatment with a tyrosine kinase inhibitor (TKI) without achieving complete remission or have relapsed after achieving complete remission, except for those who cannot tolerate TKI therapy or have contraindications to TKI treatment.
  • Positive for FLT3 mutation confirmed by leukemia cell genetic testing, or FLT3 expression ≥35%;
  • ECOG performance status score of 1-2;
  • Liver, kidney, heart, and lung functions meeting the following criteria:
  • Glomerular filtration rate (GFR) ≥60 ml/min/1.73 m² or serum creatinine ≤2 times the upper limit of normal (ULN);
  • Serum AST and ALT ≤3 times of ULN, and total bilirubin ≤1.5 times the ULN;
  • Oxygen saturation > 92%;
  • Left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion observed on ultrasound, and no clinically significant electrocardiographic abnormalities.
  • Able to understand the study and sign the informed consent form.

Who cannot join

  • Diagnosed as acute promyelocytic leukemia (APL M3);
  • With any presence of other uncontrolled malignancies (unless evaluated as unlikely to interfere with the safety or efficacy assessment of the trial);
  • Previously treated with CAR-T cells or other genetically modified cellular therapies
  • Displayed history or evidence of significant cardiovascular risks, including any of the following: congestive heart failure, unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia), coronary angioplasty within 6 months before administration, implantable cardiac defibrillator, or any clinically relevant comorbidities that pose safety risks or interfere with study assessments, procedures, or completion;
  • Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV DNA levels ≥ the detection limit in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA; positive for human immunodeficiency virus (HIV) antibodies; or positive for syphilis testing;
  • Positive for acute or chronic hepatitis C. Exceptions: acute hepatitis C with complete viral clearance; chronic hepatitis C with a sustained virological response (SVR24) 24 weeks post-treatment confirming undetectable viral load;
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  • Having history of arterial or venous thrombosis within 3 months prior to enrollment;
  • Having history of Graft-versus-host disease requiring systemic immunomodulators;
  • Having history of central nervous system diseases or conditions requiring treatment (e.g., uncontrolled seizures);
  • Having uncontrolled active infections;
  • Known allergy to any components of CI-135 CAR-T cell formulation or the lymphodepletion regimen (cyclophosphamide and fludarabine);
  • Currently pregnant or lactating female, or female subjects planning pregnancy within 1 year after cell infusion, or male subjects with partners planning pregnancy within 1 year after infusion;
  • Having other conditions deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Suning Chen, M.D. contact

86-13814881746

chensuning@sina.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

    Suning Chen, M. D., 86-13814881746, chensuning@sina.com

    Recruiting

Other trials in China

About this study

Official title: A Study to Evaluate the Safety and Efficacy of CI-135 CAR-T Cell Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia.

Being tested
Human Derived anti-CI135 CAR-T Injection
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Derived anti-CI135 CAR-T InjectionDrug

    Also called FLT3 CAR-T

    Autologous genetically modified anti-CI135 CAR transduced T cells

Study groups in NCT06760260
Study groupRoleWhat they receive
Experimental: Anti CI-135 (FLT3) CAR-T InjectionExperimentalSingle administration: 0.5 * 10^6 CAR-T cells/kg, 1.0 * 10^6 CAR-T cells/kg
Receives: Drug: Human Derived anti-CI135 CAR-T Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limited toxicity (DLT)

    Safety Indicator

    Measured: 28 days post infusion

Secondary outcomes (8)

  1. Pharmacokinetics parameters - Maximum CAR level in peripheral blood (Cmax)

    Effectiveness Metrics

    Measured: 2 years post infusion

  2. Pharmacokinetics parameters -Time to maximum CAR level in peripheral blood (Tmax)

    Effectiveness Metrics

    Measured: 2 years post infusion

  3. Pharmacokinetics parameters - 28-day Area under Curve of CAR level in peripheral blood (AUC0-28)

    Effectiveness Metrics

    Measured: 2 years post infusion

  4. Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level in peripheral blood

    Effectiveness Metrics, determined via ELISA, including but not limited to:

    Interleukin-15 (IL-15) by pg/μl blood sample; Interleukin-6 (IL-6) by pg/μl blood sample; Granzyme B by pg/μl blood sample; Interferon-γ (IFN-γ) by pg/μl blood sample; Tumor Necrocis Factor α (TNF-α) by pg/μl blood sample;

    Measured: 2 years post infusion

  5. Overall Response Rate (ORR)

    ORR defined as proportion of subjects who achieved Partial Remission (PR), Morphologic leukemia-free state (MLFS) or better (CR, CRi) according to the ELN 2017 as determined by an Investigator assessment at day 28.

    Measured: 28 days post infusion

  6. Progression-free Survival (PFS)

    PFS defined as time from date of initial infusion of CAR-T to date of first disease progression according to ELN2017 criteria, or death due to any cause, whichever occurs first.

    Measured: 2 years post infusion

  7. Overall Survival (OS)

    OS is measured from the date of the initial infusion of CAR-T to the date of the subject's death.

    Measured: 2 years post infusion

  8. Duration of Response (DOR)

    DOR will be calculated among responders (PR, MLFS or better) from the date of initial response (PR, MLFS or better) to the date of first documented evidence of progressive disease, as defined in the ELN criteria (2017).

    Measured: 2 years post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start26 Jan 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760260
Sponsor's protocol ID
HRAIN01-AML02-POC
Status last verified
Jan 2025
First submitted
30 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Human Derived anti-CI135 CAR-T Injection in people with Acute Myeloid Leukemia (AML), run by Hrain 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 18 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. 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 Suning Chen, M.D. (86-13814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicity (DLT) (time frame: 28 days post infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06760260.

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 7 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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