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NCT05442515 · ClinicalTrials.gov registry record · Phase 1
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
A Phase 1 study of Acute Lymphoblastic Leukemia and Lymphoma, Non-Hodgkin, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT05442515: Recruiting Phase 1 study of Acute Lymphoblastic Leukemia and Lymphoma, Non-Hodgkin, sponsored by National Cancer Institute (NCI).
NCT05442515 is a Phase 1 study of Acute Lymphoblastic Leukemia and Lymphoma, Non-Hodgkin that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 126 participants, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05442515, a Phase 1 study of Acute Lymphoblastic Leukemia and Lymphoma, Non-Hodgkin, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 126 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....
Primary Outcome
Assess the safety of administering escalating doses of autologous CD19/CD22-CAR engineered T cells in children and young adult with B cell ALL or lymphoma following a cyclophosphamide/fludarabine LD.
Conditions Studied
Interventions
- DRUG fludarabine
- DRUG cyclophosphamide
- BIOLOGICAL CD19/CD22-CAR-transduced T cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2022-12-28 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 1 |
What NCT05442515 shows while recruiting
NCT05442515 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (67% lower).
The record links to 10 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which fludarabine is the first listed.
NCT05442515 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05442515 about?
NCT05442515 is a clinical study titled "CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies". Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: ...
What is the current status of trial NCT05442515?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2022-12-28. Estimated completion is 2029-07-01.
What conditions does trial NCT05442515 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Lymphoma, Non-Hodgkin, B-cell Lymphoma, Acute Lymphocytic Leukemia, B-ALL.
What interventions are being tested in trial NCT05442515?
The interventions under investigation include: fludarabine (DRUG), cyclophosphamide (DRUG), CD19/CD22-CAR-transduced T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05442515?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05442515 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT05442515's enrollment target sits among peer trials
126 42nd of 131 higher than 90 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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