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NCT03241940 · ClinicalTrials.gov registry record · Phase 1
Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults w/ Recurrent or Refractory B Cell Malignancies
A Phase 1 study of Refractory Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, sponsored by Stanford University.
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT03241940: Active Phase 1 study of Refractory Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, sponsored by Stanford University.
NCT03241940 is a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Stanford University. The registered enrollment target is 33 participants, below the 43-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03241940, a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Stanford University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the best dose and side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy, and to see how well they work in treating children or young adults 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 B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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. Giving CD19/CD22-CAR T cells and chemotherapy may work better in treating children or young adults with B acute lymphoblastic leukemia.
Primary Outcome
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined.
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
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2035-08-01 |
| Phase | Phase 1 |
What the registry record for NCT03241940 still lists
NCT03241940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 43-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (23% lower).
The record links to 7 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03241940 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03241940 about?
NCT03241940 is a clinical study titled "Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults w/ Recurrent or Refractory B Cell Malignancies". This phase I trial studies the best dose and side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy, and to see how well they work in treating children or young adults with CD19 positive B acute lymphoblastic leukemia that has come back or does not re...
What is the current status of trial NCT03241940?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2017-10-20. Estimated completion is 2035-08-01.
What conditions does trial NCT03241940 study?
This clinical trial studies the following conditions: Refractory Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive, Minimal Residual Disease.
What interventions are being tested in trial NCT03241940?
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 NCT03241940?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03241940 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
Similar trials for Refractory Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03241940's enrollment target sits among peer trials
33 11th of 21 higher than 11 of 21 other Refractory Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory 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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