NCT03907527

Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Active, enrolled Phase 1 Last updated 8 November 2024

What this trial tests

Phase 1 trial testing PRGN-3005 UltraCAR-T cells in Platinum-Resistant Fallopian Tube Carcinoma in 71 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 April 2019

Primary endpoint
15 December 2024

15 November 2028

Quick facts

Lead sponsor	Precigen, Inc
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	30 April 2019
Primary completion	15 December 2024
Estimated completion	15 November 2028
Sites	2 locations across United States

Drugs / interventions tested

• PRGN-3005 UltraCAR-T cells — full drug profile →
• PRGN-3005 UltraCAR-T cells — full drug profile →

Conditions studied

• Platinum-Resistant Fallopian Tube Carcinoma — all drugs for Platinum-Resistant Fallopian Tube Carcinoma →
• Platinum-Resistant Ovarian Carcinoma — all drugs for Platinum-Resistant Ovarian Carcinoma →
• Platinum-Resistant Primary Peritoneal Carcinoma — all drugs for Platinum-Resistant Primary Peritoneal Carcinoma →
• Recurrent Fallopian Tube Carcinoma — all drugs for Recurrent Fallopian Tube Carcinoma →

Sponsor

Precigen, Inc — full company profile →

Who can join

18 and older, female only, with Platinum-Resistant Fallopian Tube Carcinoma or Platinum-Resistant Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I/Ib dose escalation, dose expansion, study to evaluate the safety and identify the recommended dose of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc.) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.

Publications & conference data

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

1. 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
2. The Past, Present, and Future of Non-Viral CAR T Cells.
   Moretti A, Ponzo M, Nicolette CA, Tcherepanova IY, et al · · 2022 · cited 103× · PMID 35757746 · DOI 10.3389/fimmu.2022.867013
3. Mucin1 and Mucin16: Therapeutic Targets for Cancer Therapy.
   Lee DH, Choi S, Park Y, Jin HS. · · 2021 · cited 53× · PMID 34681277 · DOI 10.3390/ph14101053
4. T Cell Based Immunotherapy for Cancer: Approaches and Strategies.
   Want MY, Bashir Z, Najar RA. · · 2023 · cited 44× · PMID 37112747 · DOI 10.3390/vaccines11040835
5. Barriers to Immunotherapy in Ovarian Cancer: Metabolic, Genomic, and Immune Perturbations in the Tumour Microenvironment.
   Johnson RL, Cummings M, Thangavelu A, Theophilou G, et al · · 2021 · cited 33× · PMID 34944851 · DOI 10.3390/cancers13246231
6. Immunotherapy for Peritoneal Carcinomatosis: Challenges and Prospective Outcomes.
   Ornella MSC, Badrinath N, Kim KA, Kim JH, et al · · 2023 · cited 24× · PMID 37190310 · DOI 10.3390/cancers15082383
7. CAR-T Cell Therapy in Ovarian Cancer: Where Are We Now?
   Cutri-French C, Nasioudis D, George E, Tanyi JL. · · 2024 · cited 23× · PMID 38667465 · DOI 10.3390/diagnostics14080819
8. Immunotherapy and Its Development for Gynecological (Ovarian, Endometrial and Cervical) Tumors: From Immune Checkpoint Inhibitors to Chimeric Antigen Receptor (CAR)-T Cell Therapy.
   Schepisi G, Casadei C, Toma I, Poti G, et al · · 2021 · cited 18× · PMID 33671294 · DOI 10.3390/cancers13040840