Immunotherapy Targeting Neurofibromatosis or Schwannomatosis

Who is this study for? Patients with neurofibromatosis or schwannomatosis
What treatments are being studied? Antigen-specific T cells CART+CTL+Dcvac
Status: Unknown
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
China
Department of Neurosurgery, Shenzhen Hospital, Southern Medical University
RECRUITING
Shenzhen
Shenzhen Children's Hospital
RECRUITING
Shenzhen
Shenzhen Geno-immune Medical Institute
RECRUITING
Shenzhen
Contact Information
Primary
Lung-Ji Chang, PhD
c@szgimi.org
86-075586725195
Time Frame
Start Date: 2019-09-01
Completion Date: 2022-12-31
Participants
Target number of participants: 100
Treatments
Experimental: CART/CTL/DCvac cells to treat cancer
Sponsors
Leads: Shenzhen Geno-Immune Medical Institute
Collaborators: Shenzhen Hospital of Southern Medical University, Shenzhen Children's Hospital

This content was sourced from clinicaltrials.gov