Immunotherapy Based on Antigen-specific Immune Effector Cells Targeting Neurofibromatosis or Schw… (NCT04085159) | Clinical Trial Compass
UnknownPhase 1/2
Immunotherapy Based on Antigen-specific Immune Effector Cells Targeting Neurofibromatosis or Schwannomatosis
China100 participantsStarted 2019-09-01
Plain-language summary
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.
Who can participate
Age range1 Year – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 progression on conventional MRI, or a \>10% volume increase by 3D volumetrics) over the past ≤12 months, designated as the primary target tumor OR Volumetrically measurable and ≥ 0.5 cc VS with ipsilateral progressive hearing loss over the past ≤12 months, designated as the primary target tumor.
✓. 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% critical difference threshold, compared to previous audiogram ≤ 1 year prior.
✓. 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 score.
✓. Any neurologic deficits must be stable for ≥ 1 week.
Exclusion criteria
✕. The results of immune staining of the patient's tumor-associated antigens are all negative.
What they're measuring
1
Percentage of adverse effects after CART/CTL/DCvac cells injection
✕. 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: