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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
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of DLTs and treatment-emergent adverse events
MTD or HTD and RP2D.
Secondary outcome measures
Objective Response Rate (ORR)
Overall Survival (OS)
Progression-free Survival (PFS)
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.
Find a Location
Who is running the clinical trial?
ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
5,120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need constant oxygen because of my advanced cancer or another illness.I have a systemic autoimmune disease like lupus or rheumatoid arthritis.I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.I can provide a recent biopsy sample or am willing to have one taken for the study.I do not have uncontrolled high blood pressure or serious heart problems.My blood and organ function tests show I might not be healthy enough for this trial.I have been on daily steroids for more than 3 months, not counting inhalers.I have at least one tumor that can be measured or evaluated.I've had at least one treatment for my cancer after it spread, or I can't have standard treatments.I do not have any serious illnesses that would make the study drug unsafe for me.I have had an organ transplant and take medicine to prevent rejection.My cancer is advanced, cannot be surgically removed, and has spread.I am 18 years old or older.I haven't taken part in any drug trials or received experimental treatments in the last 14 days, except for testosterone-lowering therapy.I can understand and have signed the consent form as per the ethics committee's guidelines.I can take care of myself and am up and about more than half of my waking hours.I can attend all required study visits and follow-ups.
Research Study Groups:
This trial has the following groups:- Group 1: PD-L1 t-hanK Dose Level 2
- Group 2: PD-L1 t-haNK Dose Level 1
- Group 3: PD-L1 t-haNk Dose -1a (if needed)
- Group 4: PD-L1 t-haNK Dose Level Recommended phase 2 dose (RP2D)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given its stamp of approval to PD-L1 t-haNK?
"The safety of PD-L1 t-haNK has only been preliminarily assessed, thus it was assigned a score of 1. This is due to the trial being in Phase 1 and containing limited evidence for efficacy and safety."
Answered by AI
Are there any open positions for participants in this research experiment?
"The evidence present on clinicaltrials.gov suggests that this medical trial is no longer recruiting patients, as it was posted in July 2019 and last updated May 2022. Nevertheless, there are over 3000 other studies currently seeking volunteers at the moment."
Answered by AI
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