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New treatment option for Malignant Solid Brain Tumors
Official title NK Cell Therapy for Malignant Solid Brain Tumors
ClinicalTrials.gov ID: NCT07552233
What this study is testing
What is Autologous NK cells?
Autologous NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant solid brain tumors.
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 a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy.
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
- Male or female, age 18-70 years old (both ends included)
- At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive...
- Karnofsky Performance Status (KPS) ≥ 60%
- Life expectancy \> 4 weeks, and must be able to undergo an MRI with contrast
- Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to...
You likely can't join if
- Active hepatitis B or C virus, HIV infection, or other untreated active infection
- Pregnant and lactating women
- Participants with organ failure
- Participants with a chronic disease requiring immunologic or hormonal therapy
- Participants with an allergy to immunotherapy and related cells
- Participants with uncontrolled intercurrent illness
See the full eligibility criteria
- Male or female, age 18-70 years old (both ends included)
- At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment
- Karnofsky Performance Status (KPS) ≥ 60%
- Life expectancy \> 4 weeks, and must be able to undergo an MRI with contrast
- Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤...
- Dexamethasone dose ≤ 4 mg/day or equivalent corticosteroid dose, or no dexamethasone administered
- Must have adequate organ and marrow function as defined below:
- White blood cell count (WBC) ≥ 3 x 10\^9/L
- Absolute neutrophil count (ANC) \> 1 x 10\^9/L
- Hemoglobin (Hb) ≥ 90 g/L
- Platelet (PLT) ≥ 80×10\^9/L
- Albumin transaminase (ALT) \& albumin transaminase (AST) \< 1.5 × institutional upper limit of normal (ULN)
- Serum creatinine (Cr) \< 1.5 x institutional ULN
- Total bilirubin \< 1.5 x institutional ULN
- PT \& PTT ≤ 1.25 x institutional ULN
- No obvious hereditary diseases
- Normal cardiac function with left ventricular ejection fraction \>55%
- No bleeding and coagulation disorders
- Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and/or there aren't any indications of meningitis
- Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and people are willing to use contraception (hormonal or barrier method of birth control or abstinence)...
- Signed, written informed consent
- Active hepatitis B or C virus, HIV infection, or other untreated active infection
- Pregnant and lactating women
- Participants with organ failure
- Participants with a chronic disease requiring immunologic or hormonal therapy
- Participants with an allergy to immunotherapy and related cells
- Participants with uncontrolled intercurrent illness
- Participants with psychiatric illness/social situations that would limit compliance with study requirements
- Participants with a history of organ transplantation or who are awaiting organ transplantation
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Qinhuangdao, Hebei, China
- Zhengzhou, Henan, 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, Beijing Municipality, China; Qinhuangdao, Hebei, China; Zhengzhou, Henan, 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.