EGFR bi-armed autologous activated T cells / Barbara Ann Karmanos Cancer Institute - LARVOL DELTA

Association of class II and III BRAF mutations with EGFR blockade therapy response and representation of molecularly distinct subgroups of BRAF mutations in MMR proficient CRC. (ASCO-GI 2024) - "Class I BRAF mts (V600) render aggressive biology to CRC and poor response to anti EGFR inhibitors... Class II and III BRAF mts are associated with improved outcomes with EGFR blockade and represent a distinct biological subgroup of pMMR CRC. Class III BRAF mts have lower MAPK activation, consistent with the pattern of kinase-dead mutations."

Colorectal Cancer • Gastrointestinal Cancer • BRAF • IFNG • KRAS • NRAS

Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer) (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Barbara Ann Karmanos Cancer Institute | Active, not recruiting ➔ Completed | N=30 ➔ 15

Enrollment change • Trial completion • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4 • IL2RA

BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=2 | Completed | Sponsor: Barbara Ann Karmanos Cancer Institute | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Jun 2021 | Trial primary completion date: Dec 2021 ➔ Jun 2021

Combination therapy • IO biomarker • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • IFNG • IL10 • PD-1 • PD-L1

Priming of pancreatic cancer cells with bispecific antibody armed activated T cells sensitizes tumors for enhanced chemoresponsiveness. (PubMed, Oncoimmunology) - "The impetus for this study was the remarkable clinical response seen in our earlier phase I/II clinical trial: a pancreatic cancer patient with drug resistant tumors who showed progression of disease following three infusions of anti-CD3 x anti-EGFR bispecific antibody armed activated T cells (EGFR BATs) was restarted on the initial low dose of 5-fluorouracil showed complete response, suggesting that BATs infusions may have sensitized patient's tumor for chemoresponsiveness. Gemcitabine or cisplatin-resistant cell lines show an increased proportion of CD44/CD24/EpCAM cancer stem like cells as well as an increased number of ABC transporter ABCG2 positive cells compared to the parental cell lines. These data suggest that bispecific antibody armed activated T cells can target and kill chemo-resistant tumor cells and also markedly augment subsequent chemotherapeutic responsiveness, possibly by modulating the expression of ABC transporters."

Journal • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • ABCG2 • CD24 • CD44

Bispecific Antibody Armed Activated T-cells With Aldesleukin and Sargramostim in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2; N=2; Active, not recruiting; Sponsor: Barbara Ann Karmanos Cancer Institute; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Combination therapy • IO biomarker • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • IFNG • IL10 • PD-1 • PD-L1

Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer) (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Barbara Ann Karmanos Cancer Institute; Trial completion date: Jun 2021 ➔ Dec 2021

Trial completion date • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4