BridgeMD
New treatment option for Cancer
Official title Immunotherapy Based on Antigen-specific Immune Effector Cells Targeting Neurofibromatosis or Schwannomatosis
ClinicalTrials.gov ID: NCT04085159
What this study is testing
What is Antigen-specific T cells CART/CTL and DCvac?
Antigen-specific T cells CART/CTL and DCvac is an investigational medicine, being studied as a potential treatment for cancer.
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
- The primary objective of this study is to verify the safety of antigen-specific T cells (CAR-T) and engineered immune effector cytotoxic T cells (EIE) modified by immunoregulatory genes and immune modified dendritic cell vaccine (DCvac) in the treatment of neurofibromatosis or schwannoma.
- 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 1 to 80
You may be able to join if
- Written, informed consent obtained prior to any study-specific procedures.
- Diagnosis of neurofibromatosis, or schwannomatosis
- The results of immune staining of the patient's cancer specimens positive for any one or more of a list of tumor-associated antigens.
- Age ≥ 1 years
- At least one volumetrically measurable and ≥ 0.5 cc NF-related tumor (schwannoma, ependymoma, meningioma - histological confirmation not required)...
You likely can't join if
- The results of immune staining of the patient's tumor-associated antigens are all negative.
- Participation in any other cell therapy protocols within one year.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug.
- Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study.
- Pregnant or lactating females.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
See the full eligibility criteria
- Written, informed consent obtained prior to any study-specific procedures.
- Diagnosis of neurofibromatosis, or schwannomatosis
- The results of immune staining of the patient's cancer specimens positive for any one or more of a list of tumor-associated antigens.
- Age ≥ 1 years
- At least one volumetrically measurable and ≥ 0.5 cc NF-related tumor (schwannoma, ependymoma, meningioma - histological confirmation not required) with radiographic evidence of progression (either as unequivocal...
- Progressive Hearing Loss Criteria for Enrollment: Audiogram showing drop in pure tone average (PTA) of 10dB HL at ≥ 2 nonconsecutive or consecutive frequencies or drop in speech discrimination score (SDS) below the 95%...
- Karnofsky/Lansky performance status (PS) 50-100%. Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance...
- Any neurologic deficits must be stable for ≥ 1 week.
- Adequate bone marrow reserve with
- absolute neutrophil count (ANC) ≥ 1000/mm3.
- Platelets ≥100,000/mm3.
- Adequate renal and hepatic function with
- Serum creatinine ≤ 2 x upper limit of normal (ULN).
- Serum bilirubin ≤ 2 x ULN.
- aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
- Alkaline phosphatase ≤ 5 x ULN.
- Serum bilirubin 2.0 is acceptable in the setting of known Gilbert's syndrome.
- The results of immune staining of the patient's tumor-associated antigens are all negative.
- Participation in any other cell therapy protocols within one year.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug.
- Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study.
- Pregnant or lactating females.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- Symptomatic congestive heart failure of New York heart Association Class III or IV
- unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
- severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
- uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy.)
- active (acute or chronic) or uncontrolled severe infections
- liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
- Inadequate bone marrow function:
- Absolute neutrophil count \< 1.0 x 10e9/L. Platelet count \< 100 x 10e9/L.
- Hb \< 9 g/dL.
- Inadequate liver and renal function:
- Serum (total) bilirubin \> 1.5 x ULN.
- AST \& ALT \> 2.5 x ULN (\> 5 x ULN in patients with liver metastases).
- Alkaline phosphatase \> 2.5 x ULN (or \> 5 x ULN in case of liver metastases or \> 10 x ULN in case of bone metastases).
- Serum creatinine \>2.0 mg/dl (\> 177 μmol/L).
- Urine dipstick for protein uria should be \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate \< 1 g of protein/24 hr.
- Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, 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, 1 year to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, 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.