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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 up to 5 years
Awards & highlights

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.
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).
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial 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

IMPT-314 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05826535 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Phase I Dose Level II CAR T naïve cohort, Phase I Dose Level I Refractory disease or relapse within one year of first line therapy, Phase I Dose Level I CAR T naïve cohort, Phase I Dose Level II CAR T experienced cohort, Phase I Dose Level I CAR T experienced cohort, Phase II Refractory disease or relapse within one year of first line therapy, Phase II CAR T experienced cohort, Phase I Dose Level II Refractory disease or relapse within one year of first line therapy, Phase II CAR T naïve cohort
Non-Hodgkin's Lymphoma Clinical Trial 2023: IMPT-314 Highlights & Side Effects. Trial Name: NCT05826535 — Phase 1 & 2
IMPT-314 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05826535 — Phase 1 & 2
~50 spots leftby Jun 2025
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