Study on TAK-007 for Adults with Difficult-to-Treat B-cell Non-Hodgkin Lymphoma
Sponsor: Takeda
ClinicalTrials ID:NCT05020015
This clinical trial is testing a new treatment called TAK-007 to see if it is safe and effective for adults with B-cell Non-Hodgkin Lymphoma that has returned or not responded to previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is divided into two parts. The first part aims to check for any side effects of TAK-007 in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL). The second part aims to see if the lymphoma responds to TAK-007 treatment. Participants will first receive three days of chemotherapy to lower certain white blood cells, followed by either a single injection or three weekly injections of TAK-007. Regular clinic visits will follow for check-ups.
Description
The study is testing a new treatment called TAK-007 for adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL). It has two parts: Part 1 focuses on finding the right dose and checking for side effects, while Part 2 looks at how well the treatment works.
In Part 1, participants will receive different doses of TAK-007 to find the safest and most effective dose. This part includes dose escalation and expansion phases, where participants receive TAK-007 after a short course of chemotherapy.
Once the best dose is determined, Part 2 will begin, enrolling participants to further test the treatment's effectiveness. This study is being conducted worldwide, with Part 1 in the US and Part 2 globally. Participants will be involved for up to 5 years, with regular clinic visits and a long-term follow-up study for up to 15 years to monitor safety.
Eligibility Criteria
Inclusion Criteria
- Adults with a life expectancy of at least 12 weeks.
- Good overall health with an ECOG performance status of 0 or 1.
- Diagnosed with certain types of B-cell Non-Hodgkin Lymphoma that have returned or not responded to previous treatments.
- Have measurable disease as defined by specific medical criteria.
- Have received at least two prior lines of therapy for their lymphoma.
- Adequate bone marrow, kidney, liver, heart, and lung function.
- Willing to provide a tumor tissue sample for analysis.
Exclusion Criteria
- Weigh less than 40 kg.
- Have lymphoma involving the brain or spinal cord.
- Have certain other types of lymphoma or a history of other cancers unless disease-free for at least 3 years.
- Have had a transplant or certain cell therapies within 3 months before joining the study.
- Have active infections or certain brain disorders.
- Have had recent heart problems or received a live vaccine within 6 weeks before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35249 | Birmingham | Alabama |
| Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | 90048 | Los Angeles | California |
| MedStar Georgetown University Medical Center | 20007 | Washington D.C. | District of Columbia |
| Sylvester Comprehensive Cancer Center University of Miami Hospitals and Clinics | 33136 | Miami | Florida |
| Northside Hospital | 30342 | Atlanta | Georgia |
| Northwestern Memorial Hospital | 60611 | Chicago | Illinois |
| University of Michigan Comprehensive Cancer Center | 48109 | Ann Arbor | Michigan |
| Columbia University Medical Center | 10032 | New York | New York |
| Montefiore Medical Center | 10467 | The Bronx | New York |
| DUHS Duke Blood Cancer Center | 27705 | Durham | North Carolina |
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