Immunotherapy Based on Antigen-specific Immune Effector Cells Targeting Neurofibromatosis or Schwannomatosis
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|ClinicalTrials.gov Identifier: NCT04085159|
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: Antigen-specific T cells CART/CTL and DCvac||Phase 1 Phase 2|
Neurofibromatosis (NF) is caused by a genetic change that tends to develop benign tumors around nerves. NF is a lifelong condition that affects all populations equally, regardless of gender or ethnicity. Neurofibromatosis has been classified into three distinct types: NF1, NF2, and schwannomatosis. The hallmark tumors seen in NF2 are vestibular schwannomas, formerly known as acoustic neuromas. Vestibular schwannomas are benign tumors made up of abnormal Schwann cells, which are the cells that give the nerves the lining and insulation needed to conduct information. Vestibular schwannomas can cause hearing loss in one or both ears, depending on whether the tumors are unilateral or bilateral.
Schwannomatosis is the same type of tumor as that of NF2 patients. Tumors are all related to Schwann cells. There is no cure for NF or schwannomatosis. Surgery is the only clinical method at present, and no drugs have been proved to be effective in the treatment of these tumors.
Adoptive immunotherapy based on cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. In vitro induction of tumor antigen-specific immune cells and engineering of target specific immune cells have great potential for cancer eradication. If CAR-T/CTL immunotherapy is effective, it is expected that Neurofibromatosis or Schwannomatosis tumors should shrink or disappear completely. However, the minimal residual tumor cells or cancer stem cells may exist and cause relapse to other tissues and organs. Follow-up immunotherapy must focus on enhancing the anti-tumor immunity. Therefore, this protocol includes follow-up application of DCvac to prevent recurrence. This study proposes a novel protocol of immunotherapy to evaluate the safety and effectiveness of targeting tumor antigens in patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunotherapy Targeting Neurofibromatosis or Schwannomatosis|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
|Experimental: CART/CTL/DCvac cells to treat cancer||
Biological: Antigen-specific T cells CART/CTL and DCvac
Antigen-specific T cells CART/CTL and DCvac cells to treat cancer
- Percentage of adverse effects after CART/CTL/DCvac cells injection [ Time Frame: up to one month ]To assess the safety of autologous CART/CTL/DCvac cells in patients. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
- Rate of successful CART/CTL/DCvac cell production [ Time Frame: up to one month ]The percentage of successful CART/CTL/DCvac cell generation, which is based on products which pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.
- Ability of CART/CTL/DCvac cells to induce anti-cancer reaction [ Time Frame: after 1 month from CART/CTL/DCvac cells infusion until 12 months after infusion ]measurement of concentration of tumor associated markers
- Ability of CART/CTL/DCvac cells for anti-tumor reaction [ Time Frame: after 1 month from CART/CTL/DCvac cells infusion until 24 months after infusion ]Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085159
|Contact: Lung-Ji Chang, PhDemail@example.com|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang, PhD 86-075586725195 firstname.lastname@example.org|
|Department of Neurosurgery, Shenzhen Hospital, Southern Medical University||Recruiting|
|Shenzhen, Guangdong, China, 518100|
|Contact: Jie Mao, MD +86 13955340100|
|Contact: Dinglan Wu, MD +86 13823166012|