What side effects are associated with this type of intervention?

Common treatments for cancer, such as immunotherapies and chemotherapy, have a range of side effects. Immunotherapies like pembrolizumab, atezolizumab, and nivolumab can cause immune-related adverse effects including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe treatment-related adverse effects are generally lower with immunotherapies compared to chemotherapy. Chemotherapy often results in more frequent and severe side effects, including nausea, vomiting, fatigue, neuropathy, and increased risk of infections due to bone marrow suppression. Specific to PD-L1 targeting therapies, side effects can include pneumonitis, infusion-related reactions, and other immune-mediated conditions.

What prior FDA approvals exist?

The FDA has approved several immunotherapies targeting the PD-1/PD-L1 pathway for cancer treatment. Notable approvals include nivolumab and pembrolizumab, both PD-1 inhibitors, and atezolizumab, a PD-L1 inhibitor. These drugs have shown efficacy in various cancers, including non-small cell lung cancer and melanoma, by enhancing the immune system's ability to target and destroy cancer cells. These treatments are similar to the investigational PD-L1 t-haNK, which uses engineered NK cells to target PD-L1 and boost the immune response against cancer.

What other types of research exist?

Promising novel alternatives to PD-L1 t-haNK for cancer patients in 2024 include: 1) CAR-T cell therapies targeting specific cancer antigens, 2) bispecific T-cell engagers (BiTEs) that direct T-cells to cancer cells, 3) novel immune checkpoint inhibitors such as LAG-3 and TIGIT inhibitors, 4) personalized cancer vaccines targeting neoantigens, and 5) combination therapies involving immune checkpoint inhibitors and other modalities like oncolytic viruses or targeted therapies.

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PD-L1 t-haNK

PD-L1 t-haNK for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by ImmunityBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called PD-L1 t-haNK, which uses modified immune cells to fight advanced or spreading solid cancers. The goal is to see if it is safe and effective, and to find the best dose for future studies. PD-L1 t-haNK cells are a novel type of natural killer (NK) cell engineered to target and kill cancer cells expressing PD-L1.

Who is the study for?

Adults with advanced or metastatic solid cancers who've had at least one prior treatment can join this trial. They need a measurable tumor, must provide a recent biopsy, and be able to follow the study's schedule. People with autoimmune diseases, organ transplants, severe heart conditions, uncontrolled hypertension, certain infections like HIV or inadequate organ function are excluded.

What is being tested?

The trial is testing PD-L1 t-haNK for safety and early signs of effectiveness in treating various solid tumors. It aims to find the highest dose patients can tolerate without serious side effects and recommend a dose for future studies.

What are the potential side effects?

As this is an early-phase trial assessing PD-L1 t-haNK, specific side effects aren't listed but may include typical cancer therapy reactions such as fatigue, nausea, immune-related issues or infusion reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of DLTs and treatment-emergent adverse events

MTD or HTD and RP2D.

Secondary study objectives

Objective Response Rate (ORR)

Progression-free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: PD-L1 t-hanK Dose Level 2Experimental Treatment1 Intervention

PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level 2 is 3 to 6.

Group II: PD-L1 t-haNk Dose -1a (if needed)Experimental Treatment1 Intervention

PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level -1a is 3 to six, if needed.

Group III: PD-L1 t-haNK Dose Level Recommended phase 2 dose (RP2D)Experimental Treatment1 Intervention

PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into RP2D is 4.

Group IV: PD-L1 t-haNK Dose Level 1Experimental Treatment1 Intervention

PD-L1 t-haNK will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level 1 is 3 to 6.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapy, including treatments like PD-L1 t-haNK, works by enhancing the body's immune system to recognize and attack cancer cells. PD-L1 t-haNK involves engineered natural killer (NK) cells that target the PD-L1 protein on cancer cells, which often helps tumors evade immune detection. By blocking PD-L1, these therapies prevent cancer cells from suppressing the immune response, allowing NK cells and other immune components to effectively target and destroy the cancer. This approach is crucial for cancer patients as it offers a targeted treatment option that can potentially lead to better outcomes and fewer side effects compared to traditional therapies like chemotherapy.

Nivolumab Immunotherapy in Malignant Mesothelioma: A Case Report Highlighting a New Opportunity for Exceptional Outcomes.