NCT04037241

Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases

Withdrawn Phase 2, PHASE3 Last updated 1 April 2022

What this trial tests

Phase 2, PHASE3 trial testing Anti-CEA CAR-T cells in Malignant Tumor of Pancreas Metastatic to Liver. Withdrawn.

Timeline

1 November 2021

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Sorrento Therapeutics, Inc.
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 November 2021
Primary completion	1 January 2022
Estimated completion	1 January 2022

Drugs / interventions tested

• Anti-CEA CAR-T cells — full drug profile →
• gemcitabine/nab paclitaxel
• NLIR+FU/FA — full drug profile →
• Capecitabine (capecitabine) — full drug profile →

Conditions studied

• Malignant Tumor of Pancreas Metastatic to Liver — all drugs for Malignant Tumor of Pancreas Metastatic to Liver →

Sponsor

Sorrento Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Malignant Tumor of Pancreas Metastatic to Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized open-label phase 2b study of the efficacy and safety of regional infusion therapy with Anti-CEA CAR-T cells using the hepatic immunotherapy for metastases (HITM) method and the Trisalus pressure enabling drug delivery (PEDD) device alternating with systemic chemotherapy versus chemotherapy alone in patients with CEA-expressing pancreatic adenocarcinoma with liver metastases.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engineering the next generation of cell-based therapeutics.
   Bashor CJ, Hilton IB, Bandukwala H, Smith DM, et al · · 2022 · cited 271× · PMID 35637318 · DOI 10.1038/s41573-022-00476-6
2. Molecular alterations and targeted therapy in pancreatic ductal adenocarcinoma.
   Qian Y, Gong Y, Fan Z, Luo G, et al · · 2020 · cited 231× · PMID 33008426 · DOI 10.1186/s13045-020-00958-3
3. Current advances and challenges in CAR T-Cell therapy for solid tumors: tumor-associated antigens and the tumor microenvironment.
   Yan T, Zhu L, Chen J. · · 2023 · cited 132× · PMID 36707873 · DOI 10.1186/s40164-023-00373-7
4. CAR-T cell combination therapy: the next revolution in cancer treatment.
   Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6
5. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
6. Pancreatic Cancer and Immunotherapy: A Clinical Overview.
   Timmer FEF, Geboers B, Nieuwenhuizen S, Dijkstra M, et al · · 2021 · cited 92× · PMID 34439292 · DOI 10.3390/cancers13164138
7. Tumor microenvironment in chemoresistance, metastasis and immunotherapy of pancreatic cancer.
   Wang S, Li Y, Xing C, Ding C, et al · · 2020 · cited 89× · PMID 32774994
8. The next wave of cellular immunotherapies in pancreatic cancer.
   Yeo D, Giardina C, Saxena P, Rasko JEJ. · · 2022 · cited 63× · PMID 35229033 · DOI 10.1016/j.omto.2022.01.010