NCT02470559

Treatment of High Risk or Recurrent Ovarian Cancer With Anti-CD3 x Anti-HER2 Bispecific Antibody Armed Activated T Cells (BATs), Low Dose IL-2, and GM-CSF (Phase I).

Withdrawn Phase 1 Last updated 15 February 2016

What this trial tests

Phase 1 trial testing Aldesleukin in Malignant Ovarian Clear Cell Tumor. Withdrawn.

Timeline

1 June 2015

Primary endpoint
1 February 2017

1 February 2017

Quick facts

Lead sponsor	Barbara Ann Karmanos Cancer Institute
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 June 2015
Primary completion	1 February 2017
Estimated completion	1 February 2017

Drugs / interventions tested

• Aldesleukin (ALDESLEUKIN) — full drug profile →
• HER2Bi-Armed Activated T Cells — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Sargramostim (SARGRAMOSTIM) — full drug profile →

Conditions studied

• Malignant Ovarian Clear Cell Tumor — all drugs for Malignant Ovarian Clear Cell Tumor →
• Malignant Ovarian Serous Tumor — all drugs for Malignant Ovarian Serous Tumor →
• Recurrent Fallopian Tube Carcinoma — all drugs for Recurrent Fallopian Tube Carcinoma →
• Recurrent Ovarian Carcinoma — all drugs for Recurrent Ovarian Carcinoma →

Sponsor

Barbara Ann Karmanos Cancer Institute

Who can join

18 and older, female only, with Malignant Ovarian Clear Cell Tumor or Malignant Ovarian Serous Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• MTD of IP injections in combination with the IV fixed dose of aATC determined by the incidence of dose-limiting toxicity (DLT) defined using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
  Time frame: Up to 4 weeks
• Toxicity profile of IP and IV HER2Bi-aATC at the MTD or technically feasible dose graded using NCI CTCAE version 4.0
  Time frame: Up to 2 years
  Patients who received any armed ATC but not evaluable for DLT will be analyzed separately for the toxicity profile. The toxicity will be summarized with point and exact confidence intervals.

Sponsor's own description

This phase I trial studies the side effects and best dose of activated T-cell therapy when given together with low-dose aldesleukin and sargramostim in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that is stage III-IV, has not responded to previous treatment, or has come back. Activated T cells that have been coated with bi-specific antibodies, such as anti-cluster of differentiation (CD)3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Giving activated T-cell therapy with low-dose aldesleukin and sargramostim may be a better treatment for ovarian, fallopian tube, or primary peritoneal cancer.

Publications & conference data

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

1. Bispecific antibodies and their applications.
   Fan G, Wang Z, Hao M, Li J. · · 2015 · cited 200× · PMID 26692321 · DOI 10.1186/s13045-015-0227-0
2. Tribody [(HER2)₂xCD16] Is More Effective Than Trastuzumab in Enhancing γδ T Cell and Natural Killer Cell Cytotoxicity Against HER2-Expressing Cancer Cells.
   Oberg HH, Kellner C, Gonnermann D, Sebens S, et al · · 2018 · cited 77× · PMID 29725336 · DOI 10.3389/fimmu.2018.00814
3. Principles and Current Clinical Landscape of Multispecific Antibodies against Cancer.
   Elshiaty M, Schindler H, Christopoulos P. · · 2021 · cited 71× · PMID 34073188 · DOI 10.3390/ijms22115632
4. Opportunities in immunotherapy of ovarian cancer.
   Coukos G, Tanyi J, Kandalaft LE. · · 2016 · cited 54× · PMID 27141063 · DOI 10.1093/annonc/mdw084
5. Clinical Pharmacology and Translational Aspects of Bispecific Antibodies.
   Trivedi A, Stienen S, Zhu M, Li H, et al · · 2017 · cited 53× · PMID 28297195 · DOI 10.1111/cts.12459
6. Trial Watch-Immunostimulation with cytokines in cancer therapy.
   Vacchelli E, Aranda F, Bloy N, Buqué A, et al · · 2016 · cited 43× · PMID 27057468 · DOI 10.1080/2162402x.2015.1115942
7. Bispecific antibodies: a novel approach for targeting prominent biomarkers.
   Gupta A, Kumar Y. · · 2020 · cited 3× · PMID 32614706 · DOI 10.1080/21645515.2020.1738167
8. Advances in ovarian cancer: biological insights, therapeutic innovations, and future perspectives.
   Ma X, Qu L, Wu Q, Yu Q, et al · · 2025 · PMID 41354809 · DOI 10.1186/s13048-025-01921-x