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Recurrent Malignant GliomaPhase 1NCT05540873

A Clinical Study of IL13Rα2 Targeted CAR-T in Patients With Malignant Glioma (MAGIC-I)

A Phase 1 study testing YYB-103 in people with Recurrent Malignant Glioma, run by CellabMED at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase I study to evaluate the safety and tolerability of IL13Rα2 Targeted Chimeric Antigen Receptor-T Cell in patients with Refractory or Recurrent Malignant Glioma and to evaluate the changes of AE incidence. And this study have to long term follow-up. Read more about this study

Who is it for?
Ages 19 to 74 years
Conditions the study is for
Recurrent Malignant Glioma
What is being tested?
YYB-103
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSouth Korea
Study dates
18 Jul 2022to 30 Apr 2024
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 19 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary inclusion criteria (Screening criteria)
  • : Only subjects who meet all of the following conditions conduct examinations and tests including the IHC and PBMC
  • Provision of voluntary written consent to participate in this clinical trial
  • Male and female aged ≥ 19 years to <75 years
  • Patients with histologically or cytologically confirmed progressive malignant glioma (Grade III or IV according to the WHO criteria) and histological and/or radiologic data to confirm that it is refractory or recurrent (applicable to 'Progression Disease (PD)' according to the Response Assessment for Neuro-Oncology (RANO) criteria for high grade gliomas defined by the Society for Neuro-Oncology) despite treatment applicable to the standard treatment for each stage
  • Subject with the Karnofsky Performance Status (KPS) Scale ≥ 60
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  • Subject with the life expectancy of least 12 weeks at the investigator's discretion
  • Subject who satisfies the following treatment condition, regardless of the previous line of treatment
  • At least 12 weeks after completion of the last anticancer radiation treatment
  • Other cell toxicity therapy not mentioned above: At least 3 weeks have passed
  • Non-cytotoxic agent (e.g., interferon, tamoxifen, etc.): At least 1 week has passed
  • Completion of treatment of all toxicities and AEs (other than alopecia and vitiligo) due to the previous treatment
  • Secondary Inclusion Criteria (Eligibility Criteria)
  • Subjects confirmed as positive for IL13Rα2 expression from immunostaining (IHC)
  • Subjects with Peripheral Blood Monocyte Count ≥ 7.5x10^5 cells/5 ml from the PBMC test
  • Subjects with appropriate bone marrow, liver, and kidney function by satisfying all of the following in clinical laboratory tests
  • WBC ≥ 2,000/μl
  • ANC ≥ 1,000/μl
  • Platelet count ≥ 75,000/μl
  • Hemoglobin ≥ 8.0 g/dL
  • ALT/AST ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Total bilirubin ≤ 1.5 x ULN

Who cannot join

  • Primary Exclusion Criteria (Screening criteria)
  • Subjects diagnosed with ventricular seeding, spinal drop metastasis, or leptomeningeal metastasis from radiologic testing obtained at screening
  • Subjects with findings of immunodeficiency, autoimmune disease (e.g.; rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, etc.) or inflammatory disease
  • Subjects with significant active cardiovascular disease including the following
  • Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg), unstable angina, pulmonary embolism, cerebrovascular disease, valvular disease, cardiac failure, or myocardial infarction or serious cardiac arrhythmia within the past 6 months
  • Subjects with a medical history of malignant tumor other than the study indication within 5 years of screening (however, within 3 years of screening in case of malignant tumor (e.g., appropriately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ, etc.) with minimal risk of metastasis/recurrence and death)
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  • Subjects who continuously used systemic immunosuppressants (including but not limited to cyclophosphamide, azathioprine, methotrexate, and thalidomide) other than steroids within 2 weeks of screening
  • Subjects on systemic steroids who received a dose exceeding dexamethasone 6 mg/day (or equivalent dose) within 1 week of screening(note that topical steroids, inhaled steroid, and use of transient steroids for prevention of vomiting prior to anticancer agents administration are acceptable)
  • Subjects with a history of previously using an immune cell therapy agent
  • Subjects with a medical history of severe allergy, anaphylaxis, or other hypersensitivity reaction to the chimeric or humanized antibody or fusion protein
  • Subjects who participated in other clinical trial (medicinal product or medical device) within 4 weeks of screening
  • Women of childbearing potential and men who have a plan to get pregnant until 3 months after investigational product administration, are not willing to practice appropriate contraception method*, or are not willing to maintain abstinence from sexual intercourse
  • Hormonal contraception method, intrauterine device (IUD) or intrauterine system (IUS), surgical sterilization of the subject or partner, tubal ligation, double barrier method (a combined use of a barrier method such as a female condom, cervical cap, contraceptive diaphragm, or contraceptive sponge with a male condom), single barrier method combined with spermicide)
  • Pregnant women or breastfeeding mothers
  • Subjects who are determined by the investigator to be ineligible as subjects of this clinical trial for other reason
  • Secondary Exclusion Criteria (Eligibility Criteria)
  • Subjects who are positive to any of the following virus test results at screening
  • Hepatitis B virus surface antigen (HBsAg)
  • Hepatitis C virus antibody test (anti-HCV Ab)
  • HIV antibody test (anti-HIV)
  • Subjects who are determined by the investigator to be ineligible as subjects of this clinical trial for other reason

Trial locations and contacts

1 site in 1 country.

Sungmin Jun contact

+82262048381

smjun@cellabmed.com

South Korea1 site, 1 recruiting

  • National Cancer Center, Korea

    Goyang-si, Gyeonggi-do

    Ho-Shin Gwak

    Jihye Yoon

    Recruiting

Other trials in South Korea

About this study

Official title: A Single-center, Single-arm, Open-label Phase 1 Clinical Trial to Assess the Safety and Tolerability of YYB-103, IL13Rα2 Targeted Chimeric Antigen Receptor-T Cell (CAR-T) in Treating Patients With Refractory or Recurrent Malignant Glioma

This is a phase I study to evaluate the safety and tolerability of IL13Rα2 Targeted Chimeric Antigen Receptor-T Cell in patients with Refractory or Recurrent Malignant Glioma and to evaluate the changes of AE incidence.

And this study have to long term follow-up.

Read the detailed description

This is a single-center, single-arm, open-label phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts. The objectives of this study is to assess the safety and tolerability after administration of YYB-103 (IL13Rα2 targeted CAR-T cell) in patients with malignant glioma.

YYB-103 is designed to target cancer cells expressing IL13Rα2 in cell surface. Only those subjects who are expressing IL13Rα2 and satisfy the inclusion and exclusion criteria will receive IV infusion of YYB-103.

Long term follow-up study is evaluate the safety and exploratory efficacy of IP for 15 years from the date of IP administration in patients with malignant glioma refractory or recurrent to standard therapy who participated in this study.

Subjects who participated in the Phase 1 study and received YYB-103 must have long-term follow-up for 15 years from the date of administration. During the long-term follow-up period, AEs, exploratory efficacy etc. are observed, and the observation period is every 6 months within 5 years and then yearly until 15 years.

Being tested
YYB-103
Keywords
Chimeric antigen receptor, Malignant glioma, IL13Rα2, CLM_103_MG001, YYB103, MAGIC-I
Medical subject headings
Glioma

What participants receive

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

  • YYB-103Drug

    Biological: IL13Rα2 CAR-T cells Administration method: intravenous infusion YYB-103 is manufactured according to the subject's assigned dose group and body weight.

Study groups in NCT05540873
Study groupRoleWhat they receive
IL13Rα2 targeted CAR-TExperimentalNot described
Receives: Drug: YYB-103

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    Measured: 28 days after IP administration

  2. Maximum Tolerance Dose (MTD)

    Measured: 28 days after IP administration

  3. Recommended Phase 2 Dose (RP2D)

    Measured: 28 days after IP administration

Secondary outcomes (4)

  1. Incidence of AE

    CRS and ICANS (ASTCT) / Others (CTCAE V5.0)

    Measured: 3 months, up to 15 years if necessary

  2. RCR

    RCR formation will be checked by collecting samples at 3M, 6M, and every 6 months thereafter until 5 years from IP administration, and then will be followed up annually thereafter until 15 years from IP administration via medical history without collecting samples. If all RCR test results are negative for 1 year after IP administration, sample collection will be stopped, and annual follow-up.

    Measured: 1 year, up to 15 years if necessary

  3. Pharmacokinetics and cytokine levels

    Peripheral blood (PB) and Cerebral spinal fluid (CSF)

    Measured: 3 months, up to 15 years if necessary

  4. Disease response (DCR)

    Tumor response will be assessed by comparison with baseline magnetic resonance imaging by iRANO criteria. Evaluation of DCR is the proportion of subjects with CR or PR or SD as a result of tumor response assessment.

    Measured: Baseline up to 6 months

Timeline

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

  1. First posted15 Sep 2022
  2. Study start18 Jul 2022
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion30 Apr 2024 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05540873
Sponsor's protocol ID
CLM_103_MG001
Status last verified
Sep 2022
First submitted
28 Aug 2022
Last updated
6 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YYB-103 in people with Recurrent Malignant Glioma, run by CellabMED at 1 site in South Korea.

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 23 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 6 Jan 2023. 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 South Korea. 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?

Results are not available in the source record.

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

Contact Sungmin Jun (+82262048381, smjun@cellabmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: 28 days after IP administration). The study lists 3 primary outcomes in all. 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 NCT05540873.

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 6 Jan 2023.

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