Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation
NCT ID: NCT03002519
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2017-02-08
2021-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PLX-R18
Dose Escalation- first three subjects will be enrolled in the low dose cohort, 6 subjects in the intermediate-dose cohort, and 15 subjects in the high dose cohort.
PLX-R18
Intramuscular (IM) administration of PLX-R18
Interventions
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PLX-R18
Intramuscular (IM) administration of PLX-R18
Eligibility Criteria
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Inclusion Criteria
2. At least 3 months after HCT, either autologous or allogeneic (of any source, with any preparatory regimen, for any indication), prior to study treatment.
3. Sustained platelet count ≤50,000/µL, and/or sustained Hb ≤8 g/dL and/or sustained ANC ≤1000/mm3, attributed to graft failure as a major contributor, as evident by hypocellular bone marrow.
Cytopenia should be confirmed by at least 2 consecutive blood counts, at least one of them within 28 days prior to treatment (higher transient levels following occasional blood product transfusions are allowed).
4. Stable donor cell chimerism in at least 3 consecutive tests prior to treatment (the most recent test should be within 28 days prior to treatment).
5. If the subject had allogeneic HCT for a malignant disease, the subject should have complete donor chimerism.
\*complete donor chimerism should be determined by the investigator per site's standards.
6. General performance status evaluated by Eastern Cooperative Oncology Group 0-2 scale.
7. Signed written informed consent.
1. Age ≥18 years.
2. At least 3 months after HCT, either autologous or allogeneic (of any source, with any preparatory regimen, for any indication), prior to study treatment.
3. Sustained platelet count ≤50,000/µL, and/or sustained Hb ≤8 g/dL and/or sustained ANC ≤1000/mm3, attributed to graft failure as a major contributor, as evident by hypocellular bone marrow.
Cytopenia should be confirmed by at least 2 consecutive blood counts, at least one of them within 28 days prior to treatment (higher transient levels following occasional blood product transfusions are allowed).
4\. Stable donor cell chimerism in at least 3 consecutive tests prior to treatment (the most recent test should be within 28 days prior to treatment).
5\. If the subject had allogeneic HCT for a malignant disease, the subject should have complete donor chimerism.
\*complete donor chimerism should be determined by the investigator per site's standards.
6\. General performance status evaluated by Eastern Cooperative Oncology Group 0-2 scale.
Exclusion Criteria
2. Current active infection requiring systemic treatment (if infection resolved but antibiotic coverage continues, patient may be included).
3. Acute graft versus host disease (GvHD) Grade III or IV, or severe chronic GvHD at the time of screening.
4. Subject has received prophylactic treatment with donor lymphocyte infusion (DLI) within 6 months prior to treatment, or any other cell therapy within 3 months prior to treatment.
5. History of malignancy (other than the disease that required the HCT) within 2 years prior to screening (except for skin basal cell carcinoma or squamous cell carcinoma lesions that were fully resected with no need for further treatment, and not located at the injection site).
6. History of significant transfusion reaction including: Transfusion related acute lung injury (pulmonary edema), shock, severe disturbances of liver function tests, renal dysfunction, or hemolytic anemia (as part of the transfusion reaction).
7. Known allergies to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin, gentamicin, or antihistamine.
8. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the Investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions (does not apply to transfusion reactions - see exclusion criterion 8).
9. A known history of allergic/hypersensitivity reactions to 3 or more allergens.
10. History of uncontrolled asthma (Global Initiative for Asthma Grade III IV).
11. History of severe atopic disease (including but not limited to chronic urticaria, allergic reaction with respiratory symptoms requiring systemic steroids).
12. Medical history of human immunodeficiency virus or syphilis infection.
13. Known active hepatitis B or hepatitis C infection at the time of screening.
14. A pregnant or lactating woman or a woman who plans to become pregnant during the study. In addition, any woman of childbearing potential (not sterile or postmenopausal), who is unwilling to adhere to the use of a highly effective contraception method for the duration of the study:
1. Oral/intravaginal/transdermal combined estrogen and progestogen containing hormonal contraception for at least 3 months prior to screening.
2. Oral/injectable/implantable progestogen-only hormonal contraception for at least 3 months prior to screening.
3. An intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
15. Subjects on renal replacement therapy or with estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m2 (based on Modification of Diet in Renal Disease \[MDRD\] equation).
16. Serum glutamic pyruvic transaminase (alanine aminotransferase), serum oxaloacetic pyruvic transaminase (aspartate aminotransferase) \>2.5 x upper limit of normal range.
17. International normalized ratio (INR) \>2 or subjects who are on oral anticoagulant therapy with INR \>2 unless anticoagulation treatment can be safely interrupted/discontinued around each investigational product (IP) treatment upon primary care physician and/or Investigator's discretion.
18. Severe or uncontrolled/unstable cardiac, pulmonary, or renal disease, including myocardial infarction or cerebrovascular accident within 3 months prior to treatment.
19. History of solid organ transplantation.
20. Signs and symptoms of active central nervous system disease.
21. Life expectancy \<6 months as assessed by the Investigator.
22. Subject has participated in a clinical interventional study and received the last treatment within 30 days prior to screening.
23. In the opinion of the Investigator, the subject is unsuitable for participating in the study.
18 Years
ALL
No
Sponsors
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Pluristem Ltd.
INDUSTRY
Responsible Party
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Locations
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The University of Chicago Medical Center
Chicago, Illinois, United States
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion,2330 Shawnee Mission Parkway
Westwood, Kansas, United States
University of Maryland Medical Center,22 South Greene Street
Baltimore, Maryland, United States
Mayo Clinic Cancer Center (MCCC) - Rochester,200 1st Street SW
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Baylor University Medical Center
Dallas, Texas, United States
Rambam Medical Center
Haifa, , Israel
Hadassah Ein Karem Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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References
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McGuirk JP, Metheny L 3rd, Pineiro L, Litzow M, Rowley SD, Avni B, Tamari R, Lazarus HM, Rowe JM, Sheleg M, Rothenstein D, Halevy N, Zuckerman T. Placental expanded mesenchymal-like cells (PLX-R18) for poor graft function after hematopoietic cell transplantation: A phase I study. Bone Marrow Transplant. 2023 Nov;58(11):1189-1196. doi: 10.1038/s41409-023-02068-3. Epub 2023 Aug 8.
Other Identifiers
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PLX-R18-HCT-01
Identifier Type: -
Identifier Source: org_study_id