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Acute Myeloid LeukemiaPhase 1NCT05266950

Safety and Efficacy Study of CI-135 CAR-T Cells in Subjects with Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study testing CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg) in people with Acute Myeloid Leukemia, run by Beijing Boren Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and efficacy of CI-135 CAR-T cells in subjects with relapsed or refractory Acute Lymphoblastic Leukemia. Read more about this study

Who is it for?
Ages 5 to 70 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
13 Dec 2021to 12 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 5 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥5 years old and ≤70 years old, male or female;
  • Expected survival exceeds 12 weeks;
  • Diagnosed as primary or secondary AML patients that meet the World Health Organization (WHO) classification, and meet any of the following conditions: a) AML patients who have not reached complete remission after at least 3 cycles of standard induction chemotherapy B) AML patients who have achieved complete remission after induction chemotherapy and relapse within 1 year; c) AML patients who have relapsed after achieving complete remission after induction chemotherapy for more than 1 year and have not remitted after 1 course of induction chemotherapy; d) AML patients who have relapsed after transplantation ; E) AML patients who have experienced 2 or more relapses. For patients who meet one of a), b), and c) and have FLT-3 mutations, in addition to induction therapy, they should also receive at least one TKI treatment and has not achieved complete remission or relapsed after complete remission (except patients who cannot tolerate TKI treatment or have contraindications to TKI treatment).
  • The FLT-3 mutation is positive by the leukemia cell gene detection, or the FLT-3 expression is ≥35%;
  • ECOG score 1-2;
  • Liver, kidney, heart and lung functions meet the following requirements:
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  • Glomerular filtration rate ≥60 ml/min/1.73 m2 or serum creatinine ≤2 times the upper limit of normal;
  • Serum AST, ALT≤3 times the upper limit of normal, and total bilirubin≤1.5 times the upper limit of normal;
  • Blood oxygen saturation> 92%;
  • The ventricular ejection fraction ≥50%, there is no pericardial effusion detected by ultrasound, and no clinically significant ECG changes.
  • Able to understand this experiment and sign the informed consent form.

Who cannot join

  • Diagnosed as acute promyelocytic leukemia (APL M3);
  • Accompanied with other uncontrolled malignant tumors (except those that would not interfere with the safety or efficacy evaluation of the trial).
  • Have received CAR-T cell or other genetically modified cell therapy in the past;
  • Medical history or evidence of significant cardiovascular risk, including any of the following conditions: congestive heart failure, unstable angina, clinically significant arrhythmia (such as ventricular fibrillation, ventricular tachycardia, etc.), performed coronary angioplasty 6 months before infusion, intracardiac defibrillator or any clinically-related complications that may pose a risk to the safety of the subject or interfere with the evaluation, procedures or completion of the research;
  • Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood HBV DNA titer test is greater than or equal to the lower limit of detection; those who are positive for hepatitis C virus (HCV) antibody and positive for peripheral blood HCV RNA; Human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
  • Acute or chronic hepatitis C is positive. Exceptions: acute hepatitis C with complete clearance of the virus; chronic hepatitis C, with a sustained virological response 24 weeks after completion of hepatitis C treatment (SVR24) determined an undetectable viral load;
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  • A history of arterial or venous thrombosis within 3 months before enrollment;
  • Any graft-versus-host disease that requires systemic application of immunomodulators;
  • A history of central nervous system disease or subjects who need treatment (for example, uncontrolled seizures);
  • Active infection that cannot be controlled.
  • Subjects who are known to be allergic to the components of CI-135 CAR-T cells or any components of the lymphodepletion regimen (cyclophosphamide and fludarabine).
  • Women who are pregnant or breastfeeding, and female patients who plan to become pregnant within 1 year after cell infusion, or male patients whose partners plan to become pregnant within 1 year after their infusion.
  • Other situations that are considered to be unsuitable to participate in the study by researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Gaobo Boren Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Efficacy of CI-135 CAR-T Cells in Subjects with Relapsed or Refractory Acute Myeloid Leukemia

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and efficacy of CI-135 CAR-T cells in subjects with relapsed or refractory Acute Lymphoblastic Leukemia. This study is a dose-escalation study that includes 2 dose levels, and a total of 4-7 subjects will be enrolled. CI-135 CAR-T cells will be manufactured using PBMC collected from the subjects, and will be infused intravenously into subjects after lymphodepletion.

Being tested
CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg)
Keywords
CAR-T, Leukemia, Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

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

  • CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg)Biological

    Recommended lymphodepletion regimen: cyclophosphamide (250 mg/m2/d, ×3d) and fludarabine (30 mg/m2/d, ×3d). If the patient has a hematological toxicity of grade 3 or higher, the alternative regimen is: cyclophosphamide (125mg/m2/d, ×3d) and fludarabine (15 mg/m2/d, ×3d). During lymphodepletion, physicians can give anti-myeloid drugs such as demethoxydaunorubicin or daunorubicin as appropriate.

Study groups in NCT05266950
Study groupRoleWhat they receive
CI-135 CAR-TExperimentalchimeric antigen receptor T cell treatment
Receives: Biological: CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg)

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Dose-limiting toxicity (DLT)

    Measured: 28 days post intravenous infusion

Secondary outcomes (8)

  1. Adverse events

    Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

    Measured: until two years after cell infusion

  2. Concentration of PK CAR positive T cells in peripheral blood

    PK CAR positive T cells in peripheral blood, PK CAR transgene levels in peripheral blood

    Measured: until two years after cell infusion

  3. Pharmacodynamic data in peripheral blood

    Time profile of CAR positive T cells concentrations in peripheral blood

    Measured: until two years after cell infusion

  4. Objective response rate (ORR)

    Objective response rate (ORR)

    Measured: until two years after cell infusion

  5. Duration of remission (DOR) after infusion

    refers to the time from the first assessment of CR or PR to the first assessment of disease progression or death from any cause

    Measured: until two years after cell infusion

  6. Progression-free survival (PFS) after infusion

    refers to the time from cell infusion to the first assessment of tumor progression or recurrence or death from any cause

    Measured: until two years after cell infusion

  7. Overall survival (OS) after infusion

    efers to the time from cell infusion to death due to any cause. For subjects who have dropped out before death, the dates of their last visit would be counted as their time of death; if the subject receives other new treatments, the time of death will be calculated based on the start date of the new treatment; if the study ends, the time of death will be calculated based on the end date

    Measured: until two years after cell infusion

  8. Time of human anti-mouse antibody production persist in human body （Immunogenicity）

    Immunogenicity will be analyzed during the study, including the time of human anti-mouse antibody production and how long will it last in the body.

    Measured: until two years after cell infusion

Timeline

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

  1. First posted4 Mar 2022
  2. Study start13 Dec 2021
  3. Primary completion12 Dec 2023
  4. Study completion12 Dec 2023

Why it stopped: Difficulty in joining the group

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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266950
Sponsor's protocol ID
BRYY-IIT-LCYJ-2021-018
Status last verified
Aug 2024
First submitted
29 Dec 2021
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg) in people with Acute Myeloid Leukemia, run by Beijing Boren Hospital 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 11 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: withdrawn, as of the sponsor's last update on 14 Nov 2024. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: 28 days post intravenous 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 NCT05266950.

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 14 Nov 2024.

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