RBR-8gcx9m
Recruiting
Phase 2
A phase 2a single arm study to evaluate the effect of TCN -202 (human anti-cytomegalovirus monoclonal antibody) on CMV infection in CMV (cytomegalovirus) seronegative recipients of kidney allografts from CMV seropositive donors
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- CMV seronegative patients that have received kidney allografts from CMV seropositive donors
- Sponsor
- Theraclone Sciences, Inc
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who are males or females aged 18 to 65 years, inclusive;Patients who are single\-organ recipients (kidney only) and CMV seronegative and receiving a kidney transplant from a CMV seropositive (cadaver or living) donor;Females must not be pregnant or nursing and must either be of non\-childbearing potential or must agree to use 2 acceptable methods of birth control and must agree to continue doing so for four months after the last dose of TCN\-202;Females of childbearing potential and males with female partners with childbearing potential must agree to use effective contraception and must agree to continue doing so for four months after TCN\-202 dosing;Adequate venous access and able to receive intravenous infusion;Patients must be able to understand the purpose and risks of the study and sign the informed consent form (ICF).
Exclusion Criteria
- •Patients who require anti\-lymphocyte preparations for induction therapy (indication in the rejection of transplanted organs) or those who receive a kidney with a cold ischemia time higher than 30 hours;patients presenting any acute medical condition or significant past medical history or any condition that in the opinion of the Principal Investigator (PI) or the Sponsor would complicate or compromise the study, or the well\-being of the patient;Patients with known positivity to Hepatitis B, Hepatitis C and HIV (1 and 2\);Patients with history of cancer (except for non\-melanoma skin cancer) within 2 years prior to transplantation;patients with history of drug or alcohol abuse within 6 months prior to transplantation;patients who have received an investigational product in any clinical trial within 12 months of transplantation;patients who have received prior treatment with a monoclonal antibody;Patients who require concomitant treatment with other investigational drugs.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
A clinical trial to evaluate the effect of low-dose atovaquone on the prevention of pneumocystis pneumonia in patients with rheumatic diseasesRheumatic DiseasesJPRN-jRCTs031210557Furuta Syunsuke50
Active, not recruiting
Phase 1
A single arm phase II study to investigate the efficacy, safety and pharmacokinetics of a single dose of 200 mg of i.v. BI 2536, administered once every 3 weeks in patients with advanced metastatic hormone-refractory prostate cancer - BI 2536 in advanced metastatic hormone-refractory prostate cancerAdvanced Metastatic Hormone Refractory Prostate CancerEUCTR2005-005255-18-GBBoehringer Ingelheim UK Ltd50
Active, not recruiting
Phase 1
A phase II study of linperlisib (YY-20394) in patients with relapsed or refractory peripheral T/NK cell or Cutaneous T Cell lymphomaCTIS2022-501431-16-00Shanghai Yingli Pharmaceutical Co. Ltd.107
Recruiting
Phase 2
A study to check the efficacy of Osimertinib when given with Savolitinib in Patients with Lung Cancer who have progressed after Treatment with OsimertinibHealth Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lungCTRI/2019/08/020845AstraZeneca AB
Active, not recruiting
Not Applicable
A single arm Phase II study to assess efficacy and safety of bevacizumab in combination with the standard therapy (interferon alfa-2a and vinblastine) as first-line treatment for patients with metastatic renal cell cancer (Bevacizumab with standard therapy in RCC) - Bevacizumab with standard therapy in RCCMetastatic renal cell cancerEUCTR2005-006161-13-DERoche Pharma AG