OncoMatch/Clinical Trials/NCT06904066
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Is NCT06904066 recruiting? Yes, currently enrolling (May 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 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: TP53 R175H
TP53 R175H
Required: TP53 Y220C
TP53 Y220C
Required: TP53 R248W
TP53 R248W
Required: NRAS G12V
Ras G12V
Required: KRAS G12V
Ras G12V
Required: HRAS G12V
Ras G12V
Required: NRAS G12D
Ras G12D
Required: KRAS G12D
Ras G12D
Required: HRAS G12D
Ras G12D
Required: BCR ABL1 fusion (>1.0% IS)
molecular detection of BCR-ABL1 at a ratio of >1.0% to ABL1 or another housekeeping gene on The International Scale (IS)
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Hemoglobin >=8 g/dL (no RBC transfusion 7 days); Platelets >=45,000/mcL (no transfusion 7 days); ANC >=850/mcL (no growth factor 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 by malignancy)
Cardiac function
Cardiac ejection fraction >=50% by echocardiography
Hemoglobin: >=8 g/dL without red blood cell transfusions for 7 days prior to blood count check; Platelets: >=45,000/mcL without transfusion support in the 7 days prior to the blood count check; Absolute neutrophil count: >=850/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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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