Drugs / OKT3

Trials 7

1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00619372 Jan → Apr 2008 — Hadassah Medical Organization Unknown No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT01287195 Apr 2011 → May 2013 ulcerative colitis Brigham and Women's Hospital Completed No outcome recorded
Phase 1/2 NCT00002482 Jun 1991 → ? cancer of unknown primary site St. Vincent Medical Center - Los Angeles Unknown No outcome recorded
Phase 22 trials
Phase 2 NCT00004482 Dec 1999 → Jul 2005 giant cell myocarditis Mayo Clinic Completed No outcome recorded
Phase 2 NCT00005852 Jun 1996 → Jul 2007 graft versus host disease, leukemia, myelodysplastic syndrome, myeloproliferative neoplasm +1 H. Lee Moffitt Cancer Center and Research Institute Terminated No outcome recorded Stop: Enrollment
Phase 31 trial
Phase 3 NCT00186823 Mar 2002 → Sep 2005 acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia, juvenile myelomonocytic leukemia +2 St. Jude Children's Research Hospital Completed No outcome recorded
Phase not applicable1 trial
— NCT00027443 Aug 2001 → Jul 2007 myocarditis Mayo Clinic Completed No outcome recorded
Comparator or background therapy19 trials
Phase 1 NCT00152113 Background Apr 2005 → Dec 2008 sickle cell disease St. Jude Children's Research Hospital Completed No outcome recorded
Phase 1 NCT00091611 Background Sep 2004 → Apr 2006 kidney neoplasm National Cancer Institute (NCI) Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT00001535 Background Mar 1996 → Mar 2002 AIDS, Kaposi's sarcoma National Human Genome Research Institute (NHGRI) Completed No outcome recorded
Phase 1 NCT00002572 Background Nov 1994 → Dec 1999 central nervous system neoplasm University of Colorado, Denver Completed No outcome recorded
Phase 1/2 NCT00202917 Background Feb 2004 → Jul 2009 hematopoietic and lymphoid cell neoplasm University Hospital Tuebingen Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2019-06-24 Tiziana Life Sciences LTD Results Newly Published Article Reporting Clinical Activity of Orally Administered OKT3, a Mouse Anti-CD3 Monoclonal Antibody, in Moderate to Severe Ulcerative Colitis Patients, Supports Tiziana’s Oral Monoclonal Antibody Platform tizianalifesciences.com ↗
Third party research conducted by leading U.S. institutions to be published in a peer reviewed journal Crohn’s & Colitis 360 shows orally administered anti-CD3 resulted in anti-inflammatory gene expression with no serious treatment related adverse events up to a dose of 1 mg of OKT3
1996-09-01 7 Hills Pharma, LLC Results Alpha 4 beta 1 (CD49d/CD29) integrin costimulation of human T cells enhances transcription factor and cytokine induction in the absence of altered sensitivity to anti-CD3 stimulation 7hillspharma.com ↗
Furthermore, the dose of OKT3 required to achieve half-maximal activation was the same using PMA or different concentrations of alpha 4 beta 1 ligands.

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 26 sources stand behind the page.

FieldValueCited text
Known as OKT3 “Haploidentical stem cell transplant recipients will receive a reduced intensity conditioning regimen consisting of OKT-3, Fludarabine, Thiotepa , and Melphalan followed by an...” NCT00145587 ↗
18

“Transplant recipients received a reduced intensity conditioning regimen consisting of OKT-3, fludarabine, thiotepa, and melphalan followed by an infusion of a T-cell depleted...” NCT00143559 ↗

“Approximately 10 days prior to the transplant procedure, all participants received the same preparative regimen consisting of Busulfan, cyclophosphamide, low-dose thiotepa, and OKT3.” NCT00152113 ↗

“Transplant recipients received a myeloablative conditioning regimen consisting of total body irradiation, thiotepa, cyclophosphamide, ATG, and OKT3.” NCT00186823 ↗

“Transplant recipients received a non-TBI based reduced intensity conditioning regimen consisting of OKT-3, Fludarabine Thiotepa, and Melphalan.” NCT00145613 ↗

“Anti-CD3 Murine Monoclonal Antibody OKT3, MOAB OKT3; with Cyclophosphamide, CTX, NSC-26271” NCT00002482 ↗

“the other arm utilized negative selection with the anti-CD3 antibody OKT-3” NCT00186823 ↗

“anti-CD3 monoclonal antibody (OKT3)” NCT00004022 ↗

“OKT-3 (5mg/d) from day -5 to day +3” NCT01220544 ↗

“OKT3” NCT00145626 ↗

NCT01205087 ↗

Show 8 more sources

Known as MOAB OKT3 “Anti-CD3 Murine Monoclonal Antibody OKT3, MOAB OKT3; with Cyclophosphamide, CTX, NSC-26271” NCT00002482 ↗
Known as Muromonab ClinicalTrials.gov intervention name — accepted as the source's own label NCT00566696 ↗
Known as Muromonab-CD3 “Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an...” NCT00145626 ↗
9

NCT00027443 ↗

NCT00005852 ↗

NCT00002589 ↗

NCT00004482 ↗

NCT00004024 ↗

NCT00450983 ↗

NCT00004022 ↗

NCT00002572 ↗

NCT00002482 ↗

Action Deplete “Muromonab-CD3 has been shown to reduce the number of lymphocytes” NCT00027443 ↗
Modality Monoclonal antibody “Anti-CD3 Murine Monoclonal Antibody” NCT00002482 ↗
Route Intravenous “muromonab-CD3 IV once daily for 10 days” NCT00004482 ↗