Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
Approximately forty-eight (48) participants will be randomized 1:1 to receive
(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of
observation, by 10 μg/kg twice a week for 3 weeks (maximum 7 administrations adjusted to
patient's length of stay in the hospital) or (b) Intramuscular (IM) placebo (normal saline)
at the same frequency.
The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of
these patients and observe possible association with a clinical improvement.
This cohort is dedicated to oncology patients
Drug: CYT107
IM administration at 10µg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
Other Name: Interleukin-7
Drug: Placebo
Same number, volume and frequency of IM administration of saline
Other Name: Saline
Inclusion Criteria:
1. A written, signed informed consent, or emergency oral consent, by the patient or the
patient's legally authorized representative, and the anticipated ability for
participant to be re-consented in the future for ongoing Study participation
2. Patient receiving active or recent chemotherapy or immunotherapy (within 6 months) for
cancer (and/or)
3. Patients who have received hematopoietic stem cell transplantation (for a diagnosis
other than lymphoma) within the past 1 year (and/or)
4. Patients who received CAR-T cell therapy within the past 1 year (but not within last
30 days- see also exclusion criteria number 6 & 7) (and/or)
5. Patients receiving hormonal therapy for cancer (and/or)
6. Patients who have undergone surgery or radiotherapy for cancer within the past 6
months
7. Patients with newly diagnosed (biopsy proven) malignancy who have not yet received
cancer treatment but get COVID pneumonia in the interim (Incl. Criteria 11)
8. Men and women aged ≥ 25 - 80 (included) years of age
9. Hospitalized patients with one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3,
collected at baseline or no more than 72h before baseline .
From this time point the investigator may choose to further postpone the commencement
of IL-7 (CYT107) treatment according to patient's clinical status.
10. Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at
>4L per minute nasal cannula or greater to keep saturations >90%, non-invasive
positive pressure ventilation (e.g., BIPAP), or patients intubated/ventilated for
respiratory failure
11. Confirmed infection with COVID-19 by any acceptable test available/utilized at each
site
12. Willingness and ability to practice contraception regardless of the gender of the
patient during 5 months after last drug exposure
Exclusion Criteria:
1. Pregnancy or breast feeding;
2. ALT and/or AST > 5 x ULN
3. Known, active auto-immune disease;
4. Patients with a history of lymphoid malignancy
5. Patients with any malignancy that is present at time of enrollment where treating
physician expects life expectancy due to the underlying malignancy to be less than 6
months
6. Patients who received CAR-T cell therapy within the past 30 days or with unresolved
cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity
syndrome (ICANS)
7. Patients with unresolved grade > 2 toxicities from prior chemotherapy, immunotherapy,
or CAR-T cell therapy
8. Patients with past history of Solid Organ transplant.
9. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral
load.
10. Hospitalized patients with refractory hypoxia, defined as inability to maintain
saturation >85% with maximal available therapy for >6 hours
11. Patients with a mechanical ventilation support ≥ 7 days
12. Patients with chronic kidney dialysis
13. Patients with a SOFA score ≥ 9 at baseline
14. Patients with a BMI > 40
15. Patients showing an increase of the NEWS2 score by more than 6 points during the
screening/ baseline period (48 to 72 hrs prior to first administration)
16. Patients with hospital admission Rockwood Clinical Frailty Scale ≥ 6. (assessed as
patient or proxy 4-week recall of chronic health and frailty status prior to COVID
infection)
11. Patients under guardianship
Memorial sloan kettering
New York, New York, United States
MD Anderson cancer center
Houston, Texas, United States