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NCT03233854 · ClinicalTrials.gov registry record · Phase 1
CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies
A Phase 1 study of B Acute Lymphoblastic Leukemia and Philadelphia Chromosome Positive, sponsored by Stanford University.
- Active
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT03233854: Active Phase 1 study of B Acute Lymphoblastic Leukemia and Philadelphia Chromosome Positive, sponsored by Stanford University.
NCT03233854 is a Phase 1 study of B Acute Lymphoblastic Leukemia and Philadelphia Chromosome Positive that is active but no longer recruiting, run by Stanford University. The registered enrollment target is 56 participants, below the 1,025-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03233854, a Phase 1 study of B Acute Lymphoblastic Leukemia and Philadelphia Chromosome Positive, is active but no longer recruiting, sponsored by Stanford University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy and NKTR-255, and to see how well they work in treating patients with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19/CD22 proteins. These proteins are commonly found on diffuse large B-cell lymphoma and B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. Giving CD19/CD22-CAR T cells and chemotherapy in combination with NKTR-255 may work better in treating patients with diffuse large B-cell lymphoma or B acute lymphoblastic leukemia.
Primary Outcome
Safety data will be analyzed per standard methods and interpreted descriptively for each dose cohort. Safety data will be summarized for each dose cohort separately and for all dose cohorts combined. Adverse events will be assessed using the CTCAE version 4.03 for type and severity of event. Serious Adverse Events will be summarized for each dose cohort and for all dose cohorts combined. Reasons for discontinuation of study therapy will be tabulated.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- BIOLOGICAL Chimeric Antigen Receptor T-Cell Therapy
- DRUG Fludarabine Phosphate
Study Locations (1)
California
- Stanford University, School of Medicine - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2035-09-01 |
| Phase | Phase 1 |
What the registry record for NCT03233854 still lists
NCT03233854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,025-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03233854 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03233854 about?
NCT03233854 is a clinical study titled "CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies". This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy and NKTR-255, and to see how well they work in treating patients with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatmen...
What is the current status of trial NCT03233854?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2017-09-01. Estimated completion is 2035-09-01.
What conditions does trial NCT03233854 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive, Minimal Residual Disease, CD19 Positive.
What interventions are being tested in trial NCT03233854?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Chimeric Antigen Receptor T-Cell Therapy (BIOLOGICAL), Fludarabine Phosphate (DRUG).
Who is sponsoring clinical trial NCT03233854?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03233854 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03233854's enrollment target sits among peer trials
56 12th of 20 higher than 9 of 20 other B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B Acute Lymphoblastic Leukemia 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.
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