Ovarian Neoplasms Clinical Trial
Official title:
An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer
This is a multi-center, open-label phase 1 dose escalation trial that uses a modified 3+3 design to identify a recommended phase 2 dose (RP2D) of AB-1015 cell product. Backfill cohorts will enroll additional subjects at doses deemed to be safe for a total enrollment of up to 12 subjects per each backfill cohort on the protocol.
This study is intended for the patients who have been diagnosed with Epithelial Ovarian Cancer that either came back or did not improve after platinum treatments (platinum resistant). The purpose of this study is to test the safety of using a new treatment called Integrated Circuit T (ICT) cells (AB-1015 cells) in patients with ovarian cancer. This treatment has not been approved by the Food and Drug Administration. The goal of this study is to calculate the maximum tolerated dose of the AB-1015 cells. T cells are part of the immune system that protect the body from infection and may help fight cancer. The T cells given in this study will come from the patient and will have a genetic circuit/logic gate put in them that makes them able to recognize alkaline phosphatase, germ line/placental (ALPG/P) and mesothelin (MSLN), 2 proteins on the surface of tumor cells. These logic-gated T cells may help the body's immune system identify and kill cancer cells while sparing normal healthy tissues from toxicity. The AB-1015 cells are given intravenously, after completing 3 rounds of conditioning chemotherapy administered over 3 consecutive days. Conditioning chemotherapy prepares the body to receive the AB-1015 cells. If they continue to meet the eligibility criteria, AB-1015 cells will be given to them 2 days after the last conditioning chemotherapy round. A single infusion of the AB-1015 cells will be given to the subject intravenously. After completion of study treatment, patients are followed with serial measurements of safety, tolerability and response. This is a research study to obtain new information that may help people in the future. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03648489 -
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
|
Phase 2 | |
| Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
| Completed |
NCT02569983 -
The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research
|
||
| Terminated |
NCT02055690 -
PAZOFOS: Phase Ib and Phase II Trial of Pazopanib +/- Fosbretabulin in Advanced Recurrent Ovarian Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT02243059 -
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
|
Phase 4 | |
| Completed |
NCT01719926 -
Phase I Platinum Based Chemotherapy Plus Indomethacin
|
Phase 1 | |
| Completed |
NCT00415181 -
Pharmacogenomics of Paclitaxel in Ovarian Cancer
|
N/A | |
| Completed |
NCT00243685 -
Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis
|
Phase 2/Phase 3 | |
| Recruiting |
NCT01789229 -
Establishment of a Tumor Bank for Tissue Samples
|
||
| Completed |
NCT00069160 -
Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00772863 -
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT00046800 -
Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT00035100 -
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
|
Phase 2 | |
| Terminated |
NCT00034372 -
Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma
|
Phase 2 | |
| Completed |
NCT00001272 -
A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients
|
Phase 1 | |
| Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
| Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±)
|
Phase 1/Phase 2 | |
| Completed |
NCT02227654 -
Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
|
N/A | |
| Not yet recruiting |
NCT04055038 -
Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC)
|
Phase 2/Phase 3 |