Status:
TERMINATED
Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19
Lead Sponsor:
Universitätsklinikum Köln
Collaborating Sponsors:
ZKS Köln
Hannover Medical School
Conditions:
Moderate COVID-19-infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
December 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04762186
Start Date
December 8 2021
End Date
August 3 2022
Last Update
September 15 2022
Active Locations (1)
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1
Department I for Internal Medicine University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany, 50937