Health Trials

Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma

ConditionsAIDS-Related Diffuse Large B-cell LymphomaAIDS-Related Non-Hodgkin LymphomaHIV InfectionRecurrent Diffuse Large B-Cell LymphomaRecurrent Grade 3b Follicular LymphomaRecurrent High Grade B-Cell LymphomaRecurrent Non-Hodgkin LymphomaRecurrent Primary Mediastinal (Thymic) Large B-Cell LymphomaRecurrent Transformed B-Cell Non-Hodgkin LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Grade 3b Follicular LymphomaRefractory High Grade B-Cell LymphomaRefractory Non-Hodgkin LymphomaRefractory Primary Mediastinal (Thymic) Large B-Cell LymphomaRefractory Transformed B-Cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAIDS Malignancy Consortium

About this trial

This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.

Eligibility criteria

Qualifiers

Participant with age >= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants < 18 years of age, children are excluded from this study

Participant is able to understand and willing to sign a written informed consent document before any study procedures

Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)

High-grade B-cell lymphoma

Disqualifiers

Participants felt to have a high prospect of clinically benefiting from autologous transplantation

Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study

Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that has the potential to interfere with the safety or efficacy assessment of the investigational regimen

Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis

Trial design

Treatments tested in this trial

  • Axicabtagene Ciloleucel
  • Cyclophosphamide
  • Fludarabine

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

6
California
City of Hope Comprehensive Cancer Center91010, Duarte United States
Illinois
University of Illinois at Chicago60612, Chicago United States
New York
Memorial Sloan Kettering Cancer Center10065, New York United States
Ohio
The Ohio state University43210, Columbus United States

Sponsors and collaborators

AIDS Malignancy Consortium

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Memorial Sloan Kettering Cancer Center

Collaborator

Source ClinicalTrials.gov