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New treatment option for Recurrent Glioblastoma IDH Wildtype
Official title A Clinical Trial of P134 Cells in Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT07318818
What this study is testing
What is P134 cell injection?
P134 cell injection is an investigational medicine, being studied as a potential treatment for recurrent glioblastoma idh wildtype.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, single-arm, dose-escalation and expansion Phase 1/2 clinical trial designed to evaluate the safety, tolerability and efficacy of P134 cells in patients with recurrent glioblastoma, to explore the maximum tolerated dose (MTD)and recommended Phase 2 dose (RP2D), and to characterize the cytokinetic profile of CAR-T cells in the cerebrospinal fluid of patients. Eligible participants are adults diagnosed with recurrent or progressive glioblastoma who are confirmed as grade 4 glioblastoma (IDH wild-type) by histopathology or molecular pathology.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Voluntary written informed consent.
- 18-70 years of age (inclusive), male or female.
- Recurrent or progressive glioblastoma, histopathologically or molecularly diagnosed consistent with grade 4 glioblastoma (IDH wild-type) (refer to...
- Positive CD44 or CD133 antigen expression in tumor tissue confirmed by IHC, defined as ≥1% of tumor cells showing positive CD44 or CD133 IHC...
- At least one measurable lesion meeting RANO 2.0 criteria and having a radiographically assessed measurable lesion ≤ 3 cm in longest diameter
You likely can't join if
- Highly allergic constitution or history of severe allergy, or allergy to related cell products
- Receipt of biologic anti-tumor therapy (including monoclonal or bispecific antibody-targeted therapy, immune checkpoint inhibitor therapy, etc.)...
- The adverse reactions caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 as evaluated by NCI CTCAE v6.0 (except alopecia, skin...
- Tumor metastasis to the brainstem or spinal cord.
- Suffering from other serious neurological diseases other than brain tumors, such as meningitis, encephalitis, myelitis and demyelination, myasthenic...
- Patients with primary immunodeficiency disease, autoimmune diseases requiring medication (such as Crohn 's disease, ulcerative colitis, rheumatoid...
See the full eligibility criteria
- Voluntary written informed consent.
- 18-70 years of age (inclusive), male or female.
- Recurrent or progressive glioblastoma, histopathologically or molecularly diagnosed consistent with grade 4 glioblastoma (IDH wild-type) (refer to WHO Classification of Central Nervous System Tumors, 5th Edition, 2021).
- Positive CD44 or CD133 antigen expression in tumor tissue confirmed by IHC, defined as ≥1% of tumor cells showing positive CD44 or CD133 IHC staining, regardless of intensity (applicable only in Phase II dose expansion...
- At least one measurable lesion meeting RANO 2.0 criteria and having a radiographically assessed measurable lesion ≤ 3 cm in longest diameter
- Patient has received prior radiation therapy and/or temozolomide/bevacizumab.
- The investigator confirmed that the patient was suitable for craniotomy cerebrospinal fluid shunt and accessory (Ommaya reservoir) implantation.
- Highly allergic constitution or history of severe allergy, or allergy to related cell products
- Receipt of biologic anti-tumor therapy (including monoclonal or bispecific antibody-targeted therapy, immune checkpoint inhibitor therapy, etc.) within 6 weeks prior to PBMC collection; receipt of radiotherapy or...
- The adverse reactions caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 as evaluated by NCI CTCAE v6.0 (except alopecia, skin pigmentation, leukoplakia, etc. which are assessed as having no safety...
- Tumor metastasis to the brainstem or spinal cord.
- Suffering from other serious neurological diseases other than brain tumors, such as meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, amyotrophic lateral sclerosis, spinal...
- Patients with primary immunodeficiency disease, autoimmune diseases requiring medication (such as Crohn 's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus), or previous history of autoimmune diseases...
- Receiving or requiring long-term use of immunosuppressive agents (except for physiological doses of systemic corticosteroids ≤ 10 mg/day prednisone equivalent, short-term ≤ 7 days corticosteroids for allergies, or...
- Trial participants who have a previous history of allogeneic bone marrow transplantation or organ transplantation, or are awaiting organ transplantation.
- HBsAg positive and HBV DNA positive, HCV Ab positive and HCV RNA positive; Treponema pallidum antibody positive; human immunodeficiency virus (HIV) antibody positive.
- Prior receipt of any gene therapy or cell therapy trial participant.
- Pregnant or lactating women.
- History of malignancy other than glioma within 5 years (except for adequately treated carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer, or stage I...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.