OncoMatch/Clinical Trials/NCT06904066
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Official title: A Phase I Study of Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Other Hematologic Malignancies
Is NCT06904066 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments for malignancy, hematologic.
Treatment: aldesleukin · cyclophosphamide · fludarabine phosphate · Individual Patient TCR-Transduced PBL · TruSight Oncology (TSO) 500 — 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 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: TP53 r175h
Targeted mutation - TP53 R175H; HLA Type - A*02:01
Required: TP53 y220c
Targeted mutation - TP53 Y220C; HLA Type - A*02:01
Required: TP53 r248w
Targeted mutation - TP53 R248W; HLA Type - A*68:01
Required: KRAS g12v
Targeted mutation - Ras G12V; HLA Type - A*11:01
Required: KRAS g12d
Targeted mutation - Ras G12D; HLA Type - A*11:01
Required: KRAS g12d
Targeted mutation - Ras G12D; HLA Type - C*08:02
Required: KRAS g12v
Targeted mutation - Ras G12V; HLA Type - C*01:02
Required: NRAS g12v
RAS mutations can be in NRAS, KRAS or HRAS as these oncogenes have the same amino acid sequence at the location of the targeted neoepitopes.
Required: NRAS g12d
RAS mutations can be in NRAS, KRAS or HRAS as these oncogenes have the same amino acid sequence at the location of the targeted neoepitopes.
Required: HRAS g12v
RAS mutations can be in NRAS, KRAS or HRAS as these oncogenes have the same amino acid sequence at the location of the targeted neoepitopes.
Required: HRAS g12d
RAS mutations can be in NRAS, KRAS or HRAS as these oncogenes have the same amino acid sequence at the location of the targeted neoepitopes.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Lab requirements
Blood counts
Hemoglobin >=8 g/dL; Platelets >=35,000/mcL without transfusion in prior 7 days; ANC >=800/mcL without exogenous growth factor in prior 10 days
Kidney function
Serum Creatinine: <= 1.5 mg/dL
Liver function
Total bilirubin: <= 2.0 mg/dL (Gilbert's syndrome <3 mg/dL); ALT/AST <= 3x ULN (<=5x ULN if liver involvement)
Cardiac function
Ejection fraction >=50% by echocardiography with no hemodynamically significant pericardial effusion
Participants must have adequate organ function as defined below: Hemoglobin >=8 g/dL; Platelets >=35,000/mcL without transfusion support in the 7 days prior to enrollment; Absolute neutrophil count >=800/mcL without exogenous growth factor administration within the 10 days prior to the blood count check; Total bilirubin: <= 2.0 mg/dL. Except for participants with Gilbert's syndrome (who must have a total bilirubin <3 mg/dL); Alanine transaminase (ALT) and aspartate transaminase (AST): <= to 3 times the upper limit of the institutional normal unless liver involvement by malignancy is demonstrated. If liver involvement with malignancy is detected, ALT and AST must be <= 5 times the upper limit of normal; Serum Creatinine: <= 1.5 mg/dL; Cardiac ejection fraction of greater than or equal to 50% by echocardiography with no evidence of hemodynamically significant pericardial effusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06904066 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require TP53?
Yes, TP53 r175h is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 y220c is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 r248w is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify