huCART19-IL18-CD428z Cells for CD19+ Cancers in HIV

AC
Overseen ByAbramson Cancer Center Clinical Trials Service
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Pennsylvania
Must be taking: Antiretroviral therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SB

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

I have been stable on my HIV medication for at least 28 days with no planned changes.
My follicular lymphoma returned or did not respond after two treatments.
I have signs of active disease within the last 12 weeks.
See 14 more

Exclusion Criteria

I have severe heart failure that limits my physical activity.
I currently have graft-versus-host disease needing ongoing treatment.
I have received huCART19-IL18 therapy before.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to the infusion of huCART19-IL18-CD428z cells

1 week

Treatment

Participants receive a single fixed dose of huCART19-IL18-CD428z cells

28 days

Primary Follow-up

Participants are monitored for safety and effectiveness, including treatment-limiting toxicities and overall response rate

3 months

Extended Follow-up

Participants are monitored for long-term outcomes such as progression-free survival, event-free survival, and overall survival

Up to 15 years

Analytical Treatment Interruption (ATI)

Optional phase to evaluate the effectiveness of CAR T cells to delay or prevent viral rebound without antiretroviral therapy

Up to 2 years

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

Group I: Arm AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

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 ...

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.

https://pmc.ncbi.nlm.nih.gov/articles/PMC3388845/

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