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NCT05020015 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
A Phase 2 study of Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), sponsored by Takeda.
- Active
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 15
- Study locations
NCT05020015: Active Phase 2 study of Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), sponsored by Takeda.
NCT05020015 is a Phase 2 study of Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) that is active but no longer recruiting, run by Takeda. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05020015, a Phase 2 study of Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL. Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifestin
Conditions Studied
Interventions
- DRUG Chemotherapy Agents
- BIOLOGICAL TAK-007
Study Locations (15)
New York
- Columbia University Medical Center - New York
- Montefiore Medical Center - The Bronx
Texas
- Saint Davids South Austin Medical Center - Austin
- University of Texas MD Anderson Cancer Center - Houston
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute - Los Angeles
District of Columbia
- MedStar Georgetown University Medical Center - Washington D.C.
Florida
- Sylvester Comprehensive Cancer Center University of Miami Hospitals and Clinics - Miami
Georgia
- Northside Hospital - Atlanta
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-11-12 |
| Est. Completion | 2038-12-20 |
| Phase | Phase 2 |
What the registry record for NCT05020015 still lists
NCT05020015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) appearing as the primary indexed condition, and to 2 interventions - of which Chemotherapy Agents is the first listed.
NCT05020015 lists 15 locations in 13 states (New York, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT05020015 about?
NCT05020015 is a clinical study titled "A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)". This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iN...
What is the current status of trial NCT05020015?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2021-11-12. Estimated completion is 2038-12-20.
What conditions does trial NCT05020015 study?
This clinical trial studies the following conditions: Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL).
What interventions are being tested in trial NCT05020015?
The interventions under investigation include: Chemotherapy Agents (DRUG), TAK-007 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05020015?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05020015 being conducted?
This trial has 15 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05020015's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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