NCT04762186终止1 期
A Phase I/ Randomized Phase II Trial to Analyse Safety and Efficacy of Human SARS-CoV-2-specific T Lymphocyte Transfer in Patients With COVID-19 in Need of Treatment or at Risk of Severe COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Phase I: Dose-limiting toxicities
研究概览
简要总结
Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC
详细描述
The clinical trial will consist of a phase I and a phase II part. The main trial objective in the phase I part is to determine the recommended phase II dose (RP2D) of viable human SARS-CoV 2-specific T cells by evaluation of safety and tolerability.
In the phase II part, the primary objective is to gain first data on efficacy of adaptive therapy with viable human SARS-CoV-2-specific T cells. This will be a randomized, prospective feasibility trial.
Details to phase II will be updated after completion of phase I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
During the dose-escalation phase, the study participants and the study team are aware of the treatment as this is an open label trial.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above
- •Written informed consent from the trial subject has been obtained
- •Willing to follow contraception guidelines
- •Tested positive for SARS-CoV-2 by PCR <72 hours after swab
- •A maximum of 14 days between onset of symptoms and enrollment
- •WHO score 5 OR
- •WHO score 4 with at least one additional risk factor for disease progression
- •Acceptable risk factors are:
- •Radiographically proven lung infiltrates
- •Immunosuppression either by malignant disease or it's treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression
- •Immunosuppressive drugs or steroids at a prednisolone equivalent of <1 mg/kg BW)
- •Receipt of an autologous transplant within the last 5 years
- •Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression
- •Exclusion criteria:
- •Participation in any other clinical trial of an experimental agent treatment
- •Active GvHD or history of GvHD
- •History of CAR-T-Cell Therapy
- •COVID-19 WHO ordinal scale ≥6
- •Anticipated life-expectancy <72 hours
- •Expected duration of hospital stay <72 hours
- •Sepsis-induced leukopenia or thrombocytopenia (leukocytes <1,000/µl or platelets <50,000/µl). If the cytopenias result from underlying hematologic disease or its treatment this will not be regarded as exclusion criterion
- •CT pneumonia score ≥13 [50]
- •Any Steroids ≥1 mg/kg Prednisolon-equivalent/kg BW, besides 6 mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19
- •Pregnant or breast feeding
- •Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the subject's safe participation in and completion of the study
- •Therapeutic donor lymphocyte infusion (DLI) less than 100 days prior to IMP infusion
- •Known hypersensitivity to iron dextran
- •Known pre-existing human anti-mouse antibodies (HAMAs)
- •ontraindication against mandatory protocol-inherent comedication(s): antihistamine and/or acetaminophen
- •Failure to use highly-effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:
- •Oral hormonal contraception ('pill')
- •Dermal hormonal contraception
- •Vaginal hormonal contraception (NuvaRing®)
- •Contraceptive plaster
- •Long-acting injectable contraceptives
- •Implants that release progesterone (Implanon®)
- •Tubal ligation (female sterilization)
- •Intrauterine devices that release hormones (hormone spiral)
- •Double barrier methods
- •This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
- •Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
- •Legally incapacitated persons
- •Persons held in an institution by legal or official order
排除标准
- 未提供
研究组 & 干预措施
Dose escalation
Experimental
SARS CoV-2 infected participants will receive a single infusion over 15 to 30 minutes
干预措施: human SARS-CoV 2 specific T lymphocytes (Drug)
结局指标
主要结局
Phase I: Dose-limiting toxicities
时间窗: 28 days
Dose-limiting toxicities until Day 28 after infusion of SARS-CoV-2- specific T cells
次要结局
- Phase I: Clinical status(100 days after enrollment)
- Phase I: Hospitalization(100 days after enrollment)
- Phase I: SARS-CoV-2 PCR positivity(100 days after enrollment)
- Phase I: viral shedding in nasooropharyngeal swabs(100 days after enrollment)
- Phase I: Safety(3 Month)
- Phase I: Acute graft- vs. -host disease(100 days after enrollment)
- Phase I: Detection of viable human SARS-CoV-2-specific T lymphocyte(100 days after enrollment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase I Evaluating the Combination of Ribociclib+Capecitabine in Locally Advanced/Metastatic Breast Cancer HER2 NegativeBreast CancerNCT02754011UNICANCER18
招募中
1 期
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab MonotherapyAdvanced CancerAdvanced Solid TumorMetastasisMSI-HighMismatch Repair DeficiencyMelanomaPleural MesotheliomaHepatocellular CancerRenal Cell CancerKidney CancerNon Small Cell Lung CancerAnaplastic Lymphoma Kinase Genomic Tumor AberrationsALK Genomic Tumor AberrationsSkin CancerColorectal CancerHepatocellular CarcinomaRenal Cell CarcinomaNSCLCNCT063623697 Hills Pharma, LLC126
Unknown
1 期
Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced Solid Tumor （Phase II）Advanced Solid TumorNCT04687423Fochon Pharmaceuticals, Ltd.82
Enrolling By Invitation
1 期
Safety, Tolerability, Pharmacokinetics (PK), and Primary Clinical Efficacy of LY01616 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05865925Luye Pharma Group Ltd.78
已完成
1 期
A Study of AK-01 (LY3295668) in Solid TumorsNeoplasmsNeoplasm MetastasisTriple Negative Breast NeoplasmsHead and Neck NeoplasmsBreast NeoplasmsSolid Tumor, AdultSmall Cell Lung CarcinomaNCT03092934Eli Lilly and Company13