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Recurrent or Progressive GlioblastomaEarly Phase 1NCT06691308

WL276 CAR-T Cell Therapy for CD276 Positive Recurrent or Progressive Glioblastoma Patients

A Early Phase 1 study testing WL276 CAR-T cells in people with Recurrent or Progressive Glioblastoma, run by Beijing Immunochina Medical Science & Technology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Clinical study evaluating the safety and efficacy of WL276 CAR-T cell therapy in CD276 positive recurrent or progressive glioblastoma patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent or Progressive Glioblastoma
What is being tested?
WL276 CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
12 Nov 2024to 31 May 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with glioblastoma through histopathological examination;
  • Patients with unresectable recurrent or progressive glioblastoma who have failed or are intolerant to standard treatment; 8.1The standardized systematic treatment received by patients must comply with the 2022 edition of the "Guidelines for the Treatment of Gliomas"; 8.2Requirements for treating intolerance: Refers to patients who are unable to continue the current effective systemic standardized treatment due to toxic side effects such as vomiting, diarrhea, abdominal pain, bone marrow suppression, etc. of grade ≥ 3. Refusal due to economic or personal reasons is not accepted;
  • Age ≥ 18 years old, including boundary values;
  • Expected survival period greater than 2 months;
  • There is at least one measurable intracranial lesion that meets the criteria of Neuro Tumor Response Evaluation (RANO);
  • Patients must provide tumor samples within 2 years that meet the requirements (paraffin blocks or unstained sections with a quantity that meets the testing requirements specified in this study) and have positive CD276 expression detected by immunohistochemistry;
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  • Karnofsky (KPS) functional status score ≥ 60 points;
  • Blood routine:
  • 8.1Hemoglobin (Hb) ≥ 90g/L; 8.2Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9/L; 8.3Platelet count (PLT) ≥ 70 × 10 ^ 9/L; 8.4Absolute value of lymphocytes ≥ 0.5 × 10 ^ 9/L;
  • The liver, kidney, heart, and lung functions meet the following requirements:
  • 9.1Creatinine clearance rate ≥ 60ml/min; 9.2Alanine transaminase (ALT) and aspartate transaminase 9.3Aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBL) ≤ 1.5 × ULN (for the elevation of ALT and AST that can be explained by liver invasion, AST and ALT high limit can be upregulated up to 5-fold, and TBL high limit can be upregulated up to 3-fold); 9.4Serum albumin ≥ 3.0g/dL; 9.5Left ventricular ejection fraction ≥ 50%, no pericardial effusion [ECHO (Echocardiography, ECHO) examination], no clinically significant ECG (Electrocardiogram, ECG) results; 9.6Blood oxygen saturation is greater than 95% under non oxygen inhalation conditions.
  • Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up;
  • Those who voluntarily participate in this experiment and sign the informed consent form.

Who cannot join

  • Those who require the use of immunosuppressants; Or individuals with autoimmune diseases;
  • Patients who have received or are waiting for organ transplantation in the past;
  • The toxicity caused by previous treatment has not stabilized or recovered to ≤ level 1 (except for cases judged by the researcher to be clinically insignificant);
  • There is a large amount of uncontrollable serosal fluid accumulation (such as pleural effusion, abdominal effusion, pericardial effusion) after treatment;
  • Use any of the following drugs or treatment methods within the specified time before cell collection:
  • 5.1Used therapeutic doses of corticosteroids within one week prior to cell collection. But the use of topical and inhaled steroids is allowed; 5.2Received chemotherapy drugs within one week prior to cell collection. If the oral chemotherapy drug has passed at least 3 half lives before cell collection, it is allowed to be included in the group; 5.3Individuals who use drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;
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  • CNS diseases that have clinical significance in the past or screening, and have been assessed by researchers as having safety risks;
  • Individuals who have previously used any gene therapy products;
  • Active hepatitis B or hepatitis C virus is defined as: subjects who are positive for hepatitis B B virus surface antigen (HBsAg) or hepatitis B B core antibody (HBcAb) and whose peripheral blood HBV DNA titer is higher than the upper limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); People infected with AIDS virus and syphilis;
  • Active EBV and cytomegalovirus are defined as patients with positive or negative IgM antibodies in EBV serum but EBV-DNA levels higher than normal; Patients with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV);
  • Used the research drug within 4 weeks prior to cell collection. But if the experimental treatment is ineffective or if the disease progresses, and at least 5 half lives have passed before cell collection, it is allowed to be included in the group;
  • Received radiation therapy within 4 weeks prior to cell collection;
  • Patients who have undergone major surgical procedures or significant trauma within 4 weeks prior to cell collection, or who are expected to undergo major surgery during the study period;
  • If immunotherapy such as anti-PD1 and PD-L1 has been used before cell infusion, at least 5 half lives must be passed between the last dose and CAR-T cell infusion;
  • Abnormal cardiac function includes: long QTc syndrome or QTc interval>480 ms; Complete left bundle branch block, grade II/III atrioventricular block; Severe and uncontrolled arrhythmias requiring medication treatment; History of chronic congestive heart failure and NYHA ≥ 3 (refer to Appendix 4) with a heart ejection fraction below 50% within the 6 months prior to screening; Heart valve disease with CTCAE ≥ 3 grade; Within the first 6 months of screening, there has been a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, severe pericardial disease, or other clinically significant heart diseases;
  • Patients who require anticoagulant therapy;
  • Patients requiring long-term antiplatelet therapy;
  • Start screening for symptomatic history of venous thrombosis or pulmonary embolism within the previous 6 months;
  • History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (such as cervical, bladder, breast) (unless in a disease-free state for at least 3 years);
  • Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, can be included if the researcher evaluates that they can be controlled through treatment;
  • Unable to perform MRI examination (such as installing pacemakers, metal dentures, etc.)
  • The researcher shall determine whether the patient has any factors that affect compliance with the protocol, or is unwilling or unable to comply with the procedures required in the research protocol.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

yanping Ding, doctorate contact

01062886890

dingyanping@imunopharm.com

About this study

Official title: Clinical Study Evaluating the Safety and Efficacy of WL276 CAR-T Cell Therapy in CD276 Positive Recurrent or Progressive Glioblastoma Patients

Clinical study evaluating the safety and efficacy of WL276 CAR-T cell therapy in CD276 positive recurrent or progressive glioblastoma patients

Read the detailed description

This study is an open label, single center early exploratory clinical trial of WL276001 CAR-T cell therapy for CD276 positive recurrent or progressive glioblastoma patients. This study used an improved "3+3" experimental design for dose escalation to explore the safety and efficacy of in-situ administration of WL276001 CAR-T cells.

Being tested
WL276 CAR-T cells
Keywords
WL276 CAR-T cells, CD276 positive
Medical subject headings
Recurrence

What participants receive

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

  • WL276 CAR-T cellsCombination product

    This study intends to include 6 subjects, with 3 subjects receiving 5 * 10 ^ 6 CAR-T Cells and 3 subjects receiving 1 * 10 ^ 7 CAR-T Cells at different doses

Study groups in NCT06691308
Study groupRoleWhat they receive
CD276 positive recurrent or progressive glioblastomaExperimentalInject WL276 CAR-T cells through local intracranial administration using the Ommaya device, once a week for 3 weeks. After 3 weeks of continuous administration, perform cranial MRI imaging to evaluate tumor progression and assess drug efficacy. Propose to deliver doses of 5 * 10 ^ 6 CAR-T Cells and 1 * 10 ^ 7 CAR-T Cells in sequence, with 3 subjects enrolled in each dose group
Receives: Combination Product: WL276 CAR-T cells

What is being measured

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

  1. Evaluate the safety（Adverse event incidence rate、Incidence rate of abnormal laboratory test results） and tolerability（DLT incidence rate） of WL276 CAR-T cell therapy for CD276 positive recurrent or progressive glioblastoma

    Adverse events related to CAR-T cell therapy within 28 days after infusion, abnormal laboratory test results with clinical significance, including dose limiting toxicity (DLTs).

    Measured: Within 28 days after infusion

Secondary outcomes (2)

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS) after infusion.

    Measured: 720 days after infusion

  2. Overall Survival (OS)

    Overall Survival (OS) after infusion.

    Measured: 720 days after infusion

Timeline

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

  1. First posted15 Nov 2024
  2. Study start12 Nov 2024 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (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
Sequential
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06691308
Sponsor's protocol ID
WL276001
Status last verified
Nov 2024
First submitted
5 Nov 2024
Last updated
18 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 Early Phase 1 study testing WL276 CAR-T cells in people with Recurrent or Progressive Glioblastoma, run by Beijing Immunochina Medical Science & Technology Co., Ltd..

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 13 inclusion and 22 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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 yanping Ding, doctorate (01062886890, dingyanping@imunopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety（Adverse event incidence rate、Incidence rate of abnormal laboratory test results） and tolerability（DLT incidence rate） of WL276 CAR-T cell therapy for CD276 positive recurrent or progressive glioblastoma (time frame: Within 28 days after 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 NCT06691308.

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 18 Nov 2024.

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