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Monoclonal Antibody
BI-1206 + Rituximab for Non-Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Led By Mats Jerkeman, MD PhD
Research Sponsored by BioInvent International AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are ≥ 18 years of age by initiation of study treatment
Have measurable nodal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new antibody in combination with rituximab to treat lymphoma that has relapsed or is resistant to rituximab.
Who is the study for?
This trial is for adults over 18 with certain types of B-cell Non-Hodgkin Lymphoma that's come back or didn't respond to treatment, including a rituximab-based one. They should be able to live at least another 12 weeks, have measurable disease, and be in fair health (ECOG 0-2). Pregnant women, those with severe heart issues, active infections needing treatment, other cancers or autoimmune diseases can't join.Check my eligibility
What is being tested?
The study tests BI-1206 combined with Rituximab in patients whose indolent B-cell Non-Hodgkin Lymphoma has relapsed or is resistant to Rituximab. It's a phase 1/2a trial aiming to see how safe the combination is and how well it works against this type of lymphoma.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as infusion reactions from Rituximab and unknown risks from BI-1206 since it's new. Patients might also experience fatigue, nausea, fever or infections due to weakened immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have lymph nodes that can be measured for cancer.
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I have been treated with a rituximab-based therapy before.
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My cancer is CD20 positive.
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My condition has not improved with standard treatments or there are no standard treatments available.
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I am able to get out of my bed or chair and move around.
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My lymphoma is confirmed as FL (not grade 3B), MCL, or MZL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT)
Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab
Secondary outcome measures
Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014).
CD32b protein expression levels
Evaluation of ADA response to BI 1206.
+3 moreOther outcome measures
Measurement of PROs using the PRO-CTCAE questionnaire.
Side effects data
From 2014 Phase 3 trial • 519 Patients • NCT0133299415%
Nasopharyngitis
6%
Hypertension
1%
Bursitis
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ/TCZ or TCZ/RTX
Trial Design
2Treatment groups
Experimental Treatment
Group I: BI-1206 SCExperimental Treatment1 Intervention
BI-1206 SC Adaptive Dose Escalation Design (Bayesian logistic regression model (BLRM)
Group II: BI-1206 IVExperimental Treatment1 Intervention
BI-1206 IV Standard 3+3 Dose-Escalation Design
Find a Location
Who is running the clinical trial?
BioInvent International ABLead Sponsor
17 Previous Clinical Trials
1,639 Total Patients Enrolled
Mats Jerkeman, MD PhDPrincipal InvestigatorSenior Consultant and Adjunct Professor, Skane Univ Hospital, Lund, Sweden
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have other types of cancer besides the one being studied.My lymphoma has spread to the covering of my brain or spinal cord.I need more than 10 mg of prednisolone daily, not just as pre-medication.I have amyloidosis affecting my heart or kidneys.I am experiencing side effects from previous cancer treatments.I am 18 years old or older.I have lymph nodes that can be measured for cancer.I am still recovering from a major surgery.I have or had severe heart failure.I am willing to have biopsies of my lymph nodes or other affected tissues.I have been treated with a rituximab-based therapy before.My cancer is CD20 positive.I have Waldenstrom's Macroglobulinemia or FL3B.I haven't had chemotherapy, radiotherapy (except for specific symptom control), or immunotherapy within the specified times before starting BI-1206.I had a bone marrow or stem cell transplant from a donor within the last year.I am experiencing active symptoms from a chronic graft versus host disease.I am at high risk due to a serious illness not related to cancer, such as an active infection being treated with medication.My lymphoma has changed from a slow-growing type to a more aggressive one.My condition has not improved with standard treatments or there are no standard treatments available.I am able to get out of my bed or chair and move around.My lymphoma is confirmed as FL (not grade 3B), MCL, or MZL.
Research Study Groups:
This trial has the following groups:- Group 1: BI-1206 IV
- Group 2: BI-1206 SC
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.
How many test subjects are involved in this clinical trial?
"That is correct, the clinical trial is currently underway. According to information from clinicaltrials.gov, the study was first posted on May 16th, 2018 and updated as recently as March 1st, 2022. The study is enrolling 30 patients at a single location."
Answered by AI
What therapeutic purpose does BI1206 serve?
"BI1206 can be used as an effective treatment for diffuse large b-cell lymphoma (dlbcl), various types of b-cell lymphomas, and polyangium."
Answered by AI
What goals does this experiment hope to achieve?
"The purpose of this 28-day clinical trial is to explore the maximum tolerated dose (MTD) of BI-1206 for patients experiencing a dose-limiting toxicity (DLT). Additionally, the study will secondary outcomes including pharmacokinetic (PK) parameters for rituximab, assessment of antibody-dependent cytotoxicity (ADA) response to BI 1206, and evaluation of PK parameters for BI-1206."
Answered by AI
Can people with the ailment still sign up for this research project?
"Yes, as indicated by the information available on clinicaltrials.gov, this study is currently looking for patients to enroll. The trial was first posted on May 16th, 2018 and has been updated as recently as March 1st, 2022. They are hoping to find 30 people total to participate at only one location."
Answered by AI
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