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NCT06904066 · ClinicalTrials.gov registry record · Phase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
A Phase 1 study of Blood Cancer and Myeloid Leukemia, Acute, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 1
- Study location
NCT06904066: Recruiting Phase 1 study of Blood Cancer and Myeloid Leukemia, Acute, sponsored by National Cancer Institute (NCI).
NCT06904066 is a Phase 1 study of Blood Cancer and Myeloid Leukemia, Acute that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 86 participants, below the 258-participant average among 12 other Blood Cancer 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
NCT06904066, a Phase 1 study of Blood Cancer and Myeloid Leukemia, Acute, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Blood cancers (such as leukemias) can be hard to treat, especially if they have mutations in the TP53 or RAS genes. These mutations can cause the cancer cells to create substances called neoepitopes. Researchers want to test a method of treating blood cancers by altering a person s T cells (a type of immune cell) to target neoepitopes. Objective: To test the use of neoepitope-specific T cells in people with blood cancers Eligibility: People aged 18 to 75 years with any of 9 blood cancers. Design: Participants will have a bone marrow biopsy: A sample of soft tissue will be removed from inside a pelvic bone. This is needed to confirm their diagnosis and the TP53 and RAS mutations in their cancer cells. They will also have a skin biopsy to look for these mutations in other tissue. Participants will undergo apheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The T cells will be grown to become neoepitope-specific T cells. Participants receive drugs for 3 days to prepare their body for the treatment. The modified T cells will be given through a tube inserted into a vein. Participants will need to remain in the clinic at least 7 days after treatment. Participants will have 8 follow-up visits in the first year after treatment. They will have 6 more visits over the next 4 years. Long-term follow-up will go on for 10 more years.
Primary Outcome
Adverse Events (AE) per CTCAE v5.0, by type, grade, and frequency
Conditions Studied
Interventions
- BIOLOGICAL Individual Patient TCR-Transduced PBL
- DRUG cyclophosphamide
- DRUG aldesleukin
- DRUG fludarabine phosphate
- DEVICE TruSight Oncology (TSO) 500
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 1 |
What NCT06904066 shows while recruiting
NCT06904066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 258-participant average among 12 other Blood Cancer trials with a reported enrollment target (67% lower).
The record links to 10 conditions, with Blood Cancer appearing as the primary indexed condition, and to 5 interventions - of which Individual Patient TCR-Transduced PBL is the first listed.
NCT06904066 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06904066 about?
NCT06904066 is a clinical study titled "Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies". Background: Blood cancers (such as leukemias) can be hard to treat, especially if they have mutations in the TP53 or RAS genes. These mutations can cause the cancer cells to create substances called neoepitopes. Researchers want to test a method of treating blood cancers by altering a person s T ce...
What is the current status of trial NCT06904066?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2026-03-26. Estimated completion is 2029-04-30.
What conditions does trial NCT06904066 study?
This clinical trial studies the following conditions: Blood Cancer, Myeloid Leukemia, Acute, Neoplasms, Hematologic, Hematopoetic Myelodysplasia, Malignancy, Hematologic.
What interventions are being tested in trial NCT06904066?
The interventions under investigation include: Individual Patient TCR-Transduced PBL (BIOLOGICAL), cyclophosphamide (DRUG), aldesleukin (DRUG), fludarabine phosphate (DRUG), TruSight Oncology (TSO) 500 (DEVICE).
Who is sponsoring clinical trial NCT06904066?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06904066 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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