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CAR T-cell Therapy
Combination Therapy for Non-Hodgkin's Lymphoma
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 within 30 days after each cell infusion
Awards & highlights
Study Summary
This trial will study an experimental drug to help relapsed/refractory non-Hodgkin's lymphoma in up to 20 people. It will be tested alone and with other drugs to see how safe and effective it is.
Who is the study for?
Adults with certain types of B-cell Non-Hodgkin Lymphoma that have worsened after at least two chemotherapy treatments. Participants must have previously received anti-CD20 antibody therapy, be able to get a central line for drug infusions, and commit to follow-up visits. They should not be pregnant or breastfeeding and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing CD19t-haNK alone and combined with N803 (an IL-15 superagonist) and Rituximab in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma. It's an open-label, Phase 1 study where participants are randomly assigned to one of two groups.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, blood cell count changes which can affect immunity and clotting, as well as possible digestive issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days after each cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days after each cell infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measures
Secondary outcome measures
measures
Other outcome measures
Duration of response (DoR) in accordance with LYRIC
Overall survival (OS) after infusion
Progression-free survival (PFS) after infusion in accordance with LYRIC
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment5 Interventions
Subjects in both cohorts will initially receive lymphodepleting chemotherapy followed by a single 4-week cycle of the CD19 t-haNK single-agent regimen. Following a 1-week rest period, subjects will then receive lymphodepleting chemotherapy followed by a single 4-week cycle of CD19 t-haNK in combination with rituximab (cohort A) or in combination with rituximab and N-803 (cohort B).
Group II: Arm AExperimental Treatment4 Interventions
Subjects in both cohorts will initially receive lymphodepleting chemotherapy followed by a single 4-week cycle of the CD19 t-haNK single-agent regimen. Following a 1-week rest period, subjects will then receive lymphodepleting chemotherapy followed by a single 4-week cycle of CD19 t-haNK in combination with rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Rituximab
1999
Completed Phase 4
~1880
N803
2020
Completed Phase 2
~30
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Who is running the clinical trial?
ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
5,116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a brain disease caused by cancer.I am a chronic carrier of hepatitis B.I haven't had anti-CD19 or anti-CD20 treatment in the last 4 weeks.I am currently pregnant or breastfeeding.My lymphoma has spread to my brain or spinal cord.My lab results show my organs are not functioning well.I am not on medications that react badly with the study drugs.I do not have any active cancer except for skin cancer.I have not received a live vaccine within 6 weeks before starting chemotherapy that lowers my immune cell counts.I have had an organ transplant and take medicine to prevent rejection.I have or had inflammatory bowel disease.I have HIV with a CD4+ T-cell count below 500.I am 18 years old or older.I do not have any serious illnesses that would make the study drug unsafe for me.I am on daily medication with steroids for a long-term condition.I have high blood pressure or heart problems that are not well-managed.I developed a severe form of lymphoma or leukemia after an organ transplant.I had a stem-cell transplant or CAR T therapy less than 6 months ago, or I need ongoing treatment for GvHD.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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.
Does the research team have any current vacancies for participants?
"According to clinicialtrials.gov, this study is not currently enrolling patients. Initially posted on the 15th of November 2022 and last updated 9 days ago, 1751 other clinical trials are actively recruiting subjects at this time."
Answered by AI
Are there any attendant risks to opting for Arm B?
"With limited clinical data to substantiate its safety and efficacy, Arm B was given a score of 1."
Answered by AI
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