Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385522
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
A Clinical Trial in Adults With Non-Hodgkin Lymphoma NHL With a Particular Emphasis on Cutaneous T Cell Lymphoma CTCL Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System
Sponsor:
Boston Immune Technologies and Therapeutics
Organization:
Boston Immune Technologies and Therapeutics
Study Overview
Official Title:
A Phase 1 First-In-Human Open-Label Dose-Escalating Study to Evaluate Safety Tolerability Pharmacokinetics and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 Anti-TNFR2 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial is to learn if a new drug BITR2101 works to treat non-Hodgkin lymphoma NHL in adults with CTCL patients being sought in particular The trial also seeks to learn about the safety of this drug This drug is a protein called an antibody The drug prevents a molecule called a receptor named TNFR2 from being made TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow make more of themselves and survive When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients those cells died in the laboratory Therefore the trial seeks to enroll CTCL patients in particular in addition to other subtypes of NHL When the drug prevents the receptor from being made in certain immune cells there is increased immune activity Thus the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control In particular we want to find out if the amount of lymphoma in the body decreases while taking the drug Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug Patients should have NHL that has been previously treated that is getting worse on their current therapy and their doctors think a new treatment is needed All patients will receive BITR2101 by a 3 hour infusion into a vein periodically initially every 3 weeks There is no placebo in this trial Visits to the clinic facility will be required initially at least every week and later less frequently Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens For patients who are clearly benefiting they may be able to receive BITR2101 for another year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None