Actively Recruiting
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Led by National Cancer Institute (NCI) · Updated on 2026-05-14
86
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML, MDS, CMML, CML, T-ALL, or multiple myeloma meeting standard diagnostic criteria
- Age between 18 and 75 years old
- Malignant cells must have a TP53 or RAS mutation targeted by the study T-cell receptors
- Must have the HLA type capable of presenting the targeted neoepitope
- Bone marrow or blood cancer burden meeting specified percentages for each diagnosis
- Prior treatment requirements met, including transplant and chemotherapy history as specified
- Blast cells and plasma cells must be 1% or less of white blood cells before apheresis
- Willing to undergo intensive care and bone marrow biopsies during the study
- No systemic chemotherapy within 14 days before lymphodepleting chemotherapy or apheresis, except hydroxyurea if needed
- Adequate organ function and clinical performance status of ECOG 0 or 1
- Negative hepatitis B and C tests or negative PCR if antibodies are present
- Cardiac ejection fraction of 50% or higher
- Pulmonary function tests passed if history of lung issues
- No significant graft-versus-host disease for transplant recipients
- Willingness to remain near the clinical center during critical periods
- Willingness and ability to provide informed consent and sign a durable power of attorney
- Use of effective contraception for women and men of childbearing potential
- Willingness to discontinue breastfeeding from study start through 4 months after last dose
You will not qualify if you...
- Use of systemic immunosuppressive drugs or corticosteroids over 5 mg/day prednisone equivalent within specified time frames
- Diagnosis of MDS/Myeloproliferative neoplasia overlap syndromes or acute promyelocytic leukemia
- Receipt of mismatched or haploidentical transplant
- Tumor masses 10 cm or larger
- Positive pregnancy test in women of child-bearing potential
- Positive tests for HTLV-1/2 or HIV infection
- Need for urgent therapy due to tumor mass effects or tumor lysis syndrome
- Significant illness impairing tolerance to study treatment as judged by investigator
- Previous malignancy not in remission for at least 2 years or requiring recent treatment except certain skin cancers
- Active uncontrolled infections or recent intravenous antibiotic use
- Other criteria as determined by the principal investigator for safety and eligibility
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
G
Genevieve C Fromm
CONTACT
J
James N Kochenderfer, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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