huCART19-IL18-CD428z Cells for CD19+ Cancers in HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called huCART19-IL18-CD428z cells, a type of cell therapy, for individuals with HIV who have certain cancers, such as Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, and Richter’s Transformation. The researchers aim to assess the safety and effectiveness of this treatment for those who have not responded to other treatments. This study may suit individuals with HIV who have these cancers and have found previous treatments unsuccessful. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must be stable on your current antiretroviral therapy (ART) without changes for at least 28 days before joining. Your ART regimen cannot include a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Is there any evidence suggesting that huCART19-IL18-CD428z cells are likely to be safe for humans?
Research has shown that huCART19-IL18-CD428z cells are still in early testing stages, so limited information exists about their safety in humans. As a Phase 1 trial, this marks the first time the treatment is tested in people. This phase primarily assesses the treatment's safety and potential side effects.
Researchers closely monitor treatments in this phase to ensure safety. If serious side effects occur, the treatment will not proceed to further testing. This trial aims to gather more information about the safety of huCART19-IL18-CD428z cells in individuals with HIV and certain cancers. Participants will help researchers understand any potential risks or benefits of this new treatment.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for CD19+ cancers in HIV, which often involve chemotherapy and monoclonal antibodies, huCART19-IL18-CD428z cells use a unique approach by harnessing the power of genetically modified immune cells. This treatment is derived from CAR-T cell therapy, where a patient's T-cells are modified to target and destroy cancer cells more effectively. The addition of IL-18 and CD428z components potentially enhances the immune response, offering a more robust and sustained attack against cancer cells. Researchers are excited because this innovative mechanism could lead to improved outcomes and fewer side effects compared to traditional therapies.
What evidence suggests that huCART19-IL18-CD428z cells might be an effective treatment for CD19+ cancers in HIV?
Research has shown that a new treatment using special cells called huCART19-IL18-CD428z shows promise for treating certain types of cancer. In one study, these cells effectively treated patients with lymphoma who hadn't responded to other treatments. Some patients even experienced a complete response, meaning their cancer was no longer detectable after treatment. Another study found that 82% of patients saw their cancer shrink or disappear. These results suggest this treatment could be a strong option for people with conditions like Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and similar cancers.678910
Who Is on the Research Team?
Stefan Barta, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for people living with HIV who have certain blood cancers, including Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, or Richter's Transformation. Participants must meet specific health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
Participants receive lymphodepleting chemotherapy prior to the infusion of huCART19-IL18-CD428z cells
Treatment
Participants receive a single fixed dose of huCART19-IL18-CD428z cells
Primary Follow-up
Participants are monitored for safety and effectiveness, including treatment-limiting toxicities and overall response rate
Extended Follow-up
Participants are monitored for long-term outcomes such as progression-free survival, event-free survival, and overall survival
Analytical Treatment Interruption (ATI)
Optional phase to evaluate the effectiveness of CAR T cells to delay or prevent viral rebound without antiretroviral therapy
What Are the Treatments Tested in This Trial?
Interventions
- huCART19-IL18-CD428z cells
Trial Overview
The study is testing a new cell therapy called huCART19-IL18-CD428z cells in patients with both HIV and CD19-positive blood cancers. This is an early-phase (Phase 1) trial mainly focused on safety and finding the right dose.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single fixed dose of 7x10\^6 huCART19-IL18-CD428z cells (Dose Level 1; DL1)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Citations
Armored CAR-T Shows Promise in Lymphoma Study
Low cell doses of huCART19-IL18 showed “promising efficacy” in patients with lymphoma who previously failed anti-CD19 CAR-T therapy, the authors ...
First-in-human trial of huCART19-IL18 in patients with R/R NHL ...
Results from this study so far have been encouraging, with no unexpected toxicities being recorded and some patients already achieving complete ...
FOURTH GENERATION HUCART19‐IL18 PRODUCES ...
Low doses of IL-18-secreting CD19-CAR T cells have generated complete responses in patients, At 82% objective response rate, with a median response duration ...
Humanized CD19-Specific CAR T Cells for the Treatment ...
huCD19-CAR T cell therapy may be safe, tolerable and effective in treating patients with relapsed or refractory CD19 positive ALL.
Phase-1-Study-of-huCART19IL18CD428z-Cells-for-the- ...
(PubMed, BMC Cancer) - Oct 24, 2026 - "Experimental assessment shows that ClinNetDx achieves 98.1% classification accuracy, outperforming ...
https://pmc.ncbi.nlm.nih.gov/articles/PMC3388845/
No information is available for this page.
ClinPGx
HIV Drug Resistance Database
A curated database containing nearly all published HIV RT and protease sequences: a resource designed for researchers studying evolutionary and drug-related ...
https://authors.elsevier.com/sd/article/S0092-8674...
No information is available for this page.
HIV Drug Resistance Database
A curated database containing nearly all published HIV RT and protease sequences: a resource designed for researchers studying evolutionary and drug-related ...
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