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GliomasEarly Phase 1NCT06828341

A Single-arm, Open, Exploratory Clinical Study of Allogeneic CAR-T Cells in the Treatment of Relapsed/Refractory Brain Gliomas With Positive CD70 Expression

A Early Phase 1 study testing CAR-T in people with Gliomas, run by JIANG LONGWEI at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The goal of this clinical trial is to learn if allogeneic CAR-T cells can treat patients with advanced gliomas. The main questions it aims to answer are: Evaluate the safety of allogeneic CAR-T cells in the treatment of advanced gliomas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gliomas
What is being tested?
CAR-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
13 Jun 2024to 30 Jun 2026
Phase
Early 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Agree to follow the study treatment plan and visit plan, voluntarily enroll, and sign the informed consent in writing; 2) Aged ≥18 years old on the day of signing the informed consent, regardless of gender; 3) Patients with recurrent/refractory glioma who have failed or cannot tolerate standard treatment and whose CD70 expression is confirmed by cytology or histology; 4) According to the results of immunohistochemistry test in a tertiary hospital (if historical tissue samples show CD70 positivity, no retest is required; if historical tissue samples show CD70 negative, a puncture biopsy is required) [historical archived tissue samples within 2 years are acceptable], the CD70 expression in the tumor site of the subject meets the positive standard, that is, ≥2+; 5) According to the RANO standard (Appendix 1), there is at least one evaluable or measurable lesion; 6) The expected survival period is ≥12 weeks; 7) The baseline Kanofsky performance score (Kanofsky performance score, KPS) score ≥ 70 points; 8) Subjects have adequate organ and bone marrow function and meet the following laboratory test standards: Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×109/L (1500/mm3); platelets (PLT) ≥ 90×109/L (1×105/mm3) (no blood transfusion or use of auxiliary white blood cells and platelets within 14 days before screening); White blood cell count ≥ 3.0×109/L (3000/mm3); Hemoglobin (HGB) ≥ 9.0 g/dL; Liver function: serum bilirubin (T-Bil) ≤ 1.5 times the upper limit of normal (ULN), Gilbert's syndrome (Gilbert's syndrome) (persistent or recurrent hyperbilirubinemia, manifested as elevated unconjugated bilirubin in the absence of evidence of hemolysis or liver pathology); patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN, patients with liver metastasis, ALT and AST ≤ 5 times ULN; Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (Ccr is calculated using the Cockcroft-Gault formula, see Appendix 5); Coagulation function: international normalized ratio (INR) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; 9) The investigator judges that the patient must have fully recovered from the previous treatment toxicity to ≤ Grade 1, except for the following situations: a. Alopecia; b. Pigmentation; c. Late toxicity caused by radiotherapy, which cannot be recovered by the investigator; d. Neurotoxicity of Grade 2 or below caused by platinum (CTCAE 5.0); Fertility-bearing male and female subjects of childbearing age must use effective contraceptive methods from the time they sign the informed consent until at least 6 months after CAR-T administration, and until 2 consecutive PCR tests show that there are no more CAR-T cells in the body. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within 7 days before the first dose.

Who cannot join

  • 1) Patients who have received any treatment related to the CD70 target within 3 years; 2) Patients who have received any experimental drug treatment or used experimental devices within 28 days before CAR-T administration; 3) Patients who have received any systemic anti-tumor treatment within 28 days or 5 half-lives (whichever is longer) before CAR-T administration, including systemic chemotherapy, immunotherapy, hormone therapy (excluding glucocorticoids), targeted therapy, systemic immunomodulators (including but not limited to interferon, interleukin 2 and tumor necrosis factor), and received Chinese herbal medicine or Chinese patent medicine with anti-tumor effects within 14 days before CAR-T administration; 4) Patients who have received radiotherapy within three months before administration; 5) Patients who have received other non-CD70 target cell therapy products within two months before administration; 6) Patients who have received other cell therapy products in the past need to undergo RCL testing during the screening period, and patients with positive results in any test; 7) Patients who have received therapeutic doses of glucocorticoids within 14 days before CAR-T administration (however, physiological replacement doses of glucocorticoids are allowed, such as 10 mg/day prednisone or equivalent); 8) Patients who received oral or intravenous anticoagulation within 7 days before CAR-T cell administration; 9) Patients with other malignant tumors previously or concurrently, with the following exceptions: Carcinoma in situ that has been cured and has no signs of recurrence for at least 3 years before the study; The primary malignant tumor has been completely resected and in complete remission for ≥5 years. 10) History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11) Those with immunodeficiency or autoimmune diseases, or those who need to use immunosuppressants; 12) Those who have received live vaccine immunization within 14 days before screening, or those who need to receive live vaccine immunization during the study; 13) Severe or uncontrollable systemic disease or any unstable systemic disease, including but not limited to uncontrolled hypertension, uncontrolled hyperglycemia, hepatic and renal dysfunction or metabolic diseases, central nervous system diseases, etc.; 14) Known severe cardiovascular disease, congenital long QT syndrome, torsades de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina, or congestive heart failure of grade 3 or above (including grade 3) according to the New York Heart Association (NYHA) classification (see Appendix 3), or left ventricular ejection fraction (LVEF) <50%, QTc interval >450 ms for men and >470 ms for women ms; 15) Any one or both of the test results of Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody are positive, cytomegalovirus (CMV) antibody IgM test is positive and CMV DNA titer is more than 2 times higher than the upper limit of normal value; Epstein-Barr virus antibody IgM test is positive and EBV DNA titer is more than 2 times higher than the upper limit of normal value; Hepatitis C virus antibody is positive and hepatitis C virus (HCV) RNA titer is more than 2 times higher than the upper limit of normal value, or active hepatitis B patients (defined as HBsAg positive and peripheral blood HBV DNA titer is more than 2 times higher than the upper limit of normal value); 16) Pregnant or lactating women; The researchers believe that the subjects have other conditions that may affect compliance or are not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

Jiang Longwei, master contact

+86-13952007724

jianglw2005@163.com

China1 site, 1 recruiting
  • Nanjing Jinling Hospital

    China, Jiangsu, 210002

    Jiang Longwei, Master, +86-13952007724, jianglw2005@163.com

    Jia Shaochang, doctor

    Recruiting

Other trials in China

About this study

The goal of this clinical trial is to learn if allogeneic CAR-T cells can treat patients with advanced gliomas. The main questions it aims to answer are:

Evaluate the safety of allogeneic CAR-T cells in the treatment of advanced gliomas.

To evaluate the effectiveness of allogeneic CAR-T cells in the treatment of advanced gliomas and to study its immunological properties in patients.

Read the detailed description

In this open, single-armed study, selected patients with advanced gliomas confirmed by Histopathology will be received allogeneic CAR-T cells treatment. First, their tumor specimen will be test to evaluate the expression of CD70.The patients with positive CD70 expression will be in enrolled.Then they will be received allogeneic CAR-T cells infusion cultured from heathy adults.

Conditions
Gliomas
Being tested
CAR-T
Keywords
gliomas, car-t, allogeneic
Medical subject headings
Glioma

What participants receive

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

  • CAR-TBiological

    allogeneic CAR-T targeting CD70 that cultured from heathy adults.

Study groups in NCT06828341
Study groupRoleWhat they receive
allogeneic CAR-T targeting CD70ExperimentalThe enrolled patients will be received allogeneic CAR-T targeting CD70 that culutred from heathy adults. 1E6/kg CAR-T cells will be injected once from intrathecal.
Receives: Biological: CAR-T

What is being measured

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

  1. Evaluate the safety of allogeneic T cells in the treatment of advanced giloma patients

    The adverse events and severe adverse events will be evaluated.

    Measured: 2 years

Secondary outcomes (1)
  1. Evaluate the efficiency of allogeneic CAR-T cells in the treatment of advanced glioma patients.

    The objective clinical response will be evaluated.

    Measured: 2 years

Timeline

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

  1. First posted14 Feb 2025
  2. Study start13 Jun 2024
  3. Primary completion6 Jul 2024
  4. Study completion30 Jun 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
3 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828341
Sponsor's protocol ID
SWZL20240122
Status last verified
May 2024
First submitted
10 Feb 2025
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CAR-T in people with Gliomas, run by JIANG LONGWEI 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 1 inclusion and 1 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 14 Feb 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?

Results are not available in the source record.

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

Contact Jiang Longwei, master (+86-13952007724, jianglw2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety of allogeneic T cells in the treatment of advanced giloma patients (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Feb 2025.

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