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

Sponsors and collaborators

AIDS Malignancy Consortium

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Memorial Sloan Kettering Cancer Center

Collaborator

Source ClinicalTrials.gov