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GEN3009 for Marginal Zone Lymphoma
Study Summary
This trial is testing an antibody called GEN3009 to see if it is safe for humans and if it has any preliminary clinical activity against cancer. The study will enroll cancer patients with different types of lymphoma, and they will receive GEN3009 either as a single treatment or in combination with another antibody. The study has two parts: Part 1 will test increasing doses of GEN3009 to find the recommended dose, and Part 2 will test the recommended dose from Part 1.
- Marginal Zone Lymphoma
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Lymphoma
- Mantle Cell Lymphoma
- Chronic Lymphocytic Leukemia
- B-Cell Lymphoma
- Large B-Cell Lymphoma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had or currently have a different type of cancer than the one being studied.You have received chemotherapy or radiation therapy within the past two weeks before starting GEN3009.You have a condition that affects your immune system and requires strong medications to control it.You have received a stem cell transplant using your own cells within the past 3 months.You have a seizure disorder that requires treatment with medication like steroids or anti-epileptics. This only applies to the Combination Expansion cohort.You have received treatment with a specific type of medication that targets CD37 in the past.You have a type of B-cell NHL that has come back or is not responding to usual treatments. The experimental therapy might help you if other options haven't worked. You must have already tried at least two different types of therapy before.You have received a certain type of medication called a CD3xCD20 bispecific antibody in the past (for Combination Expansion cohort).You have previously received a type of stem cell transplant called allogeneic Hematopoietic Stem Cell Transplantation (HSCT).Side effects from previous cancer treatments have not gone away completely or are still at a mild level, except for hair loss and numbness in the hands or feet.You have had allergic reactions to certain types of antibody treatments or have had negative reactions to specific medications used in combination therapy.
- Group 1: Combination Arm
- Group 2: Monotherapy Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many sites are administering this research project?
"At present, 11 clinical trial sites are recruiting patients for this study; these include Tucson, Portland and Duarte. To reduce travel demands, it is recommended to choose the location closest to you should you decide to participate in this medical experiment."
What other investigations have been done regarding the efficacy of GEN3009?
"Currently, 6 clinical studies are attending to GEN3009 with 1 trial in Phase 3. Maastricht and Michigan host a few of these trials but there are an astonishing 509 sites running experiments on this drug."
How many individuals have enrolled in this clinical trial?
"AbbVie will be facilitating this trial from a number of locations, such as the University of Arizona Cancer Center and OHSU Knight Cancer Institute. 182 fulfilling the criteria for inclusion are necessary to commence proceedings."
Is recruitment for this research endeavor open to the public?
"Clinicaltrials.gov data verifies that this clinical trial is still open to participants since its initial posting on March 24th 2020 and most recent update on July 1st 2022."
Is this research project an innovative exploration?
"Currently, 6 GEN3009 trials are running in 56 cities and 26 nations. This drug was first assessed by Genmab during a 700 patient Phase 1 & 2 clinical trial back in 2018; since then, no further studies have been conducted."
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