OncoMatch/Clinical Trials/NCT03412877
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Is NCT03412877 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for endocrine tumors.
Treatment: Cyclophosphamide · Fludarabine · Aldesleukin · Individual Patient TCR-Transduced PBL · Pembrolizumab (KEYTRUDA(R)) — Background: A person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person. Objective: To see if gene transfer therapy of white blood cells can shrink tumors. Eligibility: People with certain metastatic cancer for which standard treatments have not worked. Design: Participants may complete screening under another protocol. Screening includes: * Getting tumor cells from a previous procedure * Medical history * Physical exam * Scans * Blood, urine, heart, and lung tests The study has 8 stages: 1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm. 2. Care at home over approximately 12 weeks. 3. Stopping therapy for 4-6 weeks while their cells are changed in a lab. 4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs. 5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart. 6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer. 7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests. 8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined. ...
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Ovarian Cancer
Breast Carcinoma
Neuroendocrine Tumor
Multiple Myeloma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (oxaliplatin) — colorectal cancer
Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan
Must have received: topoisomerase inhibitor (irinotecan) — colorectal cancer
Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan
Must have received: cytotoxic chemotherapy — breast and ovarian cancer
Participants with breast and ovarian cancer must be refractory to first-line treatment and refractory to or have refused second-line treatments
Must have received: platinum-based chemotherapy — NSCLC
Participants with NSCLC must have received at least one platinum-based chemotherapy regimen
Must have received: targeted therapy — NSCLC
Participants with NSCLC must have received at least one FDA-approved targeted treatment (when appropriate)
Must have received: somatostatin analog (lanreotide, octreotide) — endocrine tumors including neuroendocrine tumors
Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide)
Must have received: targeted therapy (everolimus, sunitinib, 177 Lu-Dotatate) — endocrine tumors including neuroendocrine tumors
must be refractory or have refused second-line treatments such as everolimus, sunitinib, or 177 Lu-Dotatate, if indicated
Must have received: immunomodulatory drug (lenalidomide) — multiple myeloma
Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide
Must have received: proteasome inhibitor — multiple myeloma
Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to...a proteosome inhibitor
Must have received: anti-CD38 antibody — multiple myeloma
Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to...an anti-CD38 antibody treatment
Must have received: stem cell transplant (autologous stem cell transplant) — multiple myeloma
Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to...an autologous stem cell transplant
Lab requirements
Blood counts
ANC > 1000/mm^3 without filgrastim; WBC ≥ 2500/mm^3; Platelet count ≥ 80,000/mm^3; Hemoglobin > 8.0 g/dL (may be transfused)
Kidney function
Serum creatinine ≤ 1.6 mg/dL
Liver function
Serum ALT/AST ≤ 5.0 x ULN; total bilirubin ≤ 2.0 mg/dL, except Gilbert's Syndrome ≤ 3.0 mg/dL
Hematology: ANC > 1000/mm^3 without filgrastim; WBC ≥ 2500/mm^3; Platelet count ≥ 80,000/mm^3; Hemoglobin > 8.0 g/dL. Chemistry: Serum ALT/AST ≤ 5.0 x ULN; Serum creatinine ≤ 1.6 mg/dL; Total bilirubin ≤ 2.0 mg/dL, except Gilbert's Syndrome ≤ 3.0 mg/dL.
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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