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CAR T-cell Therapy
IMPT-314 for Non-Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by ImmPACT Bio
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 baseline to month 24
Awards & highlights
Study Summary
This trial will test the safety of a new treatment to fight aggressive B-cell Non-Hodgkin Lymphoma (NHL). Up to 50 people will receive a single infusion of new CAR-transduced autologous T cells. Follow-up for 15 years.
Who is the study for?
Adults with aggressive B-cell Non-Hodgkin's Lymphoma who've had at least two prior treatments, including an anti-CD20 monoclonal antibody and chemotherapy. They must have a certain level of white blood cells, be in good physical condition (ECOG 0 or 1), and have relapsed or refractory disease after their last treatment. Not eligible if they've recently received other therapies, have ongoing major health issues like heart involvement by lymphoma, autoimmune diseases requiring strong medication within the past two years, or active cancer elsewhere.Check my eligibility
What is being tested?
The trial is testing IMPT-314, a new CAR T-cell therapy targeting CD19 and CD20 on cancer cells. It involves modifying a patient's own T-cells to fight cancer and giving them back via infusion after chemotherapy with fludarabine and cyclophosphamide. The study has two phases: Phase 1 for dose finding (60 patients) and Phase 2 for further safety/efficacy evaluation (40 additional participants).See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever, fatigue, inflammation in various organs; complications from the conditioning chemotherapy; possible low blood cell counts leading to increased infection risk; neurological events; allergic reactions to infused cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Incidence of DLTs and other treatment-emergent adverse events (TEAEs)
Phase I: Investigator-assessed complete response (CR) rate
Phase I: Proportion of enrolled participants who receive the target dose
+1 moreSecondary outcome measures
Phase I and II: Area under the curve from time 0 to Day 28 (AUC0-28)
Phase I and II: Cmax from time 0 to Day 28 (AUC0-28)
Phase I and II: Duration of complete response (DOCR)
+8 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Phase II Refractory disease or relapse within one year of first line therapyExperimental Treatment1 Intervention
Single dose determined during Phase I.
Group II: Phase II CAR T naïve cohortExperimental Treatment1 Intervention
Single dose determined during Phase I.
Group III: Phase II CAR T experienced cohortExperimental Treatment1 Intervention
Single dose determined during Phase I.
Group IV: Phase I Dose Level II Refractory disease or relapse within one year of first line therapyExperimental Treatment1 Intervention
Phase I 3+3 design Dose level 2: 3×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window
Group V: Phase I Dose Level II CAR T naïve cohortExperimental Treatment1 Intervention
Phase I 3+3 design Dose level 2: 3×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window
Group VI: Phase I Dose Level II CAR T experienced cohortExperimental Treatment1 Intervention
Phase I 3+3 design Dose level 2: 3×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window
Group VII: Phase I Dose Level I Refractory disease or relapse within one year of first line therapyExperimental Treatment1 Intervention
Phase I 3+3 design Dose level 1: 1×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window
Group VIII: Phase I Dose Level I CAR T naïve cohortExperimental Treatment1 Intervention
Phase I 3+3 design Dose level 1: 1×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window
Group IX: Phase I Dose Level I CAR T experienced cohortExperimental Treatment1 Intervention
Phase I 3+3 design Dose level 1: 1×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window
Find a Location
Who is running the clinical trial?
ImmPACT BioLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received certain treatments within specific time frames before joining.I am facing an urgent cancer-related health issue.My lymphoma is aggressive and confirmed by a biopsy.My heart has been affected by lymphoma.My condition has returned or didn't respond to treatment.I am fully active or restricted in physically strenuous activity but can do light work.I am experiencing side effects from previous cancer treatments.I have had a stem cell transplant from a donor.I had a stem cell transplant using my own cells within the last 6 weeks.I have an autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.I have been cancer-free for over 3 years, except for non-melanoma skin cancer or carcinoma in situ.My cancer has spread to my brain or spinal cord.I am 18 years old or older.I have undergone at least 2 treatments including specific drugs.I have had gene-modified T cell therapy, but not for CD19.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Dose Level I Refractory disease or relapse within one year of first line therapy
- Group 2: Phase I Dose Level II Refractory disease or relapse within one year of first line therapy
- Group 3: Phase II CAR T naïve cohort
- Group 4: Phase II Refractory disease or relapse within one year of first line therapy
- Group 5: Phase I Dose Level I CAR T naïve cohort
- Group 6: Phase II CAR T experienced cohort
- Group 7: Phase I Dose Level II CAR T naïve cohort
- Group 8: Phase I Dose Level I CAR T experienced cohort
- Group 9: Phase I Dose Level II CAR T experienced cohort
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.
Are there numerous facilities conducting this clinical experiment in the city?
"The University of Iowa in Iowa City, Ohio, the UC Physicians Company LLC in Cincinnati, and the Huntsman Cancer Institute Salt Lake City are among the sites that will be participating in this experiment. Additionally, there are 4 other research centres collaborating on it."
Answered by AI
Is this trial currently recruiting participants?
"According to clinicaltrials.gov, this experiment is not presently recruiting participants; although the listing was initially posted on April 12th 2023 and last updated around the same time. Despite this study's inactivity in patient recruitment at present, there are 1,750 other studies actively searching for volunteers right now."
Answered by AI
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