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NCT05535855 · ClinicalTrials.gov registry record · Phase 1
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
A Phase 1 study of Acute Lymphoblastic Leukemia and Acute Lymphoid Leukemia, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT05535855: Recruiting Phase 1 study of Acute Lymphoblastic Leukemia and Acute Lymphoid Leukemia, sponsored by University of Colorado, Denver.
NCT05535855 is a Phase 1 study of Acute Lymphoblastic Leukemia and Acute Lymphoid Leukemia that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 29 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05535855, a Phase 1 study of Acute Lymphoblastic Leukemia and Acute Lymphoid Leukemia, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This open-label, single arm Phase 1/1b trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults with B-ALL that are in first complete remission with MRD positivity. This trial will enroll 10 patients during Phase 1 for apheresis, treatment with lymphodepleting chemotherapy, and UCD19 CAR T cell infusion. Patients will be assessed for DLTs (within 42 days after CAR T infusion) to determine a maximum tolerated dose (MTD), duration of B cell aplasia, overall response rate (at 1-3-, 6- and 12-months), and overall survival and event free survival (at 12- and 24- months) post UCD19 CAR T infusion. After the initial dose escalation phase, an additional 12 participants will be enrolled in the dose expansion at the MTD to determine preliminary efficacy.
Primary Outcome
The occurrence and frequency of Adverse Events will be graded using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading criteria.
Conditions Studied
Interventions
- DRUG CD19 Directed CAR T Cell
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 1 |
What NCT05535855 shows while recruiting
NCT05535855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CD19 Directed CAR T Cell is the first listed.
NCT05535855 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05535855 about?
NCT05535855 is a clinical study titled "UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1". This open-label, single arm Phase 1/1b trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults with B-ALL that are in first complete remission with MRD positivity. This trial will enroll 10 patients during Phase 1 fo...
What is the current status of trial NCT05535855?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2024-01-24. Estimated completion is 2030-06-30.
What conditions does trial NCT05535855 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Acute Lymphoid Leukemia.
What interventions are being tested in trial NCT05535855?
The interventions under investigation include: CD19 Directed CAR T Cell (DRUG).
Who is sponsoring clinical trial NCT05535855?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05535855 being conducted?
This trial has 1 study location across Colorado. 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 NCT05535855's enrollment target sits among peer trials
29 96th of 131 higher than 36 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.
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