Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK

Status Recruiting

Clinical Trial Summary

This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched BK specific cytotoxic T lymphocyte (CTL) lines (BK-CTLs) generated by ex vivo expansion to mediate antiviral activity in patients with any type of malignancies, and/or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDs), and/or history of solid organ transplant with BK and JC infections. SECONDARY OBJECTIVE: I. To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in patients with any type of malignancies, and/or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections. OUTLINE: Patients receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously (IV) over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 7 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy. After completion of study treatment, patients are followed up periodically for 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02479698
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact	Amanda L. Olson, MD
Phone	713-792-8750
Email	ALOlson@mdanderson.org
Status	Recruiting
Phase	Phase 2
Start date	July 23, 2015
Completion date	July 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03516318` - Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria	N/A
Completed	`NCT04653194` - Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'	Phase 3
Completed	`NCT01792570` - DRV/r + RPV QD: Efficacy and Toxicity Reduction	Phase 3
Active, not recruiting	`NCT04826562` - Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)	Phase 4
Completed	`NCT04191967` - Thermocoagulation for Treatment of Precancerous Cervical Lesions	N/A
Completed	`NCT02812329` - Intervention to Encourage HIV Testing and Counseling Among Adolescents	Phase 1
Completed	`NCT02919306` - Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults	Phase 1/Phase 2
Completed	`NCT02651376` - Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients	Phase 1/Phase 2
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Recruiting	`NCT02392884` - HIV Medication Adherence in Underserved Populations	N/A
Completed	`NCT01944371` - Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study	Phase 1/Phase 2
Recruiting	`NCT01778374` - Mater-Bronx Rapid HIV Testing Project.	N/A
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT01490346` - Tissue Drug Levels of HIV Medications	N/A
Completed	`NCT01076179` - Kaletra in Combination With Antiretroviral Agents	N/A
Completed	`NCT01460433` - Problems With Immune Recovery in the Gut Tissue	N/A
Completed	`NCT00317460` - Buprenorphine and Integrated HIV Care	Phase 4
Terminated	`NCT04240210` - Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)	Phase 4
Active, not recruiting	`NCT04704336` - Integration of Hypertension Management Into HIV Care in Nigeria	N/A
Completed	`NCT03254277` - 3BNC117-LS First-in-Human Phase 1 Study	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms