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Clinical trials
catalyst calendar across sponsors →Studies where TCRT is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
35 interventional · 2 observational · 9 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRsNCT05292859observationalTo assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells | — | Completed | Biological: Neoantigen specific TCR-T cell drug product | Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Cholangiocarcinoma, Ovarian Cancer, Ovary Neoplasm, Squamous Cell Lung Cancer, Adenocarcinoma of Lung, Adenosquamous Cell Lung Cancer | 7 | 2025-05-30actual | 2025-07-30 |
| HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid TumorsNCT05124743observationalNumber of Participants Positive for Human Leukocyte Antigen (HLA)-A*02 | — | Terminatedsponsor's stated reason: TCR001-002 protocol was combined with TCR001-201 protocol, which was terminated due to business decisions. | — | Ovarian Cancer, Endometrial Cancer, Colo-rectal Cancer, Cholangiocarcinoma, Non-small Cell Lung Cancer, Pancreas Cancer | 19 | 2023-08-14actual | 2025-07-30 |
| Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid TumorsNCT05194735results2025-11-10Number of Participants With Treatment-Emergent Adverse EventsNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Funding | Biological: Neoantigen specific TCR-T cell drug product, Aldesleukin (IL-2) | Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Cholangiocarcinoma, Ovarian Cancer, Endometrial Cancer, Ovarian Carcinoma, Ovary Neoplasm, Squamous Cell Lung Cancer, Adenocarcinoma of Lung, Adenosquamous Cell Lung Cancer | 8 | 2023-08-14actual | 2025-11-10 |
| A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPGNCT03330197results2025-08-12The Safety and Tolerability of Intratumoral Ad-RTS-hIL-12 and Veledimex as Measured by Dose Limiting Toxicities and Compliance.Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision due to slow accrual | Biological: Ad-RTS-hIL-12 · Drug: Oral Veledimex - Arm 1 (Pediatric Brain Tumor), Oral Veledimex - Arm 2 (DIPG) | Pediatric Brain Tumor, Diffuse Intrinsic Pontine Glioma | 6 | 2021-09-10actual | 2025-08-12 |
| Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive GlioblastomaNCT04006119results2025-04-18Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Sponsor Decision | Biological: Ad-RTS-hIL-12 · Drug: Veledimex, Cemiplimab-Rwlc | Glioblastoma | 40 | 2021-08-05actual | 2025-04-18 |
| A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102NCT03636477results2025-08-12Number of Participants With Adverse Events (AEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: Ad-RTS-hIL-12 · Drug: veledimex, Nivolumab | Glioblastoma | 21 | 2020-10-15actual | 2025-08-12 |
| A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant GliomaNCT02026271results2025-04-16Safety and Tolerability of Varying Doses of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex Doses in Subjects With Recurrent or Progressive Glioblastoma or Grade III Malignant GliomaOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: Ad-RTS-hIL-12 · Drug: veledimex | Glioblastoma Multiforme, Anaplastic Oligoastrocytoma | 40 | Aug 2019actual | 2025-04-16 |
| Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102NCT03679754results2025-08-28Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: Ad-RTS-hIL-12 · Drug: veledimex | Glioblastoma | 36 | 2019-04-02actual | 2025-08-28 |
| A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast CancerNCT02423902results2025-08-28Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study DiscontinuationOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: The study was terminated after 9 subjects had enrolled under Protocol Amend 1 because of slower than expected accrual. Protocol Amendment 2 (16 May 2016) was submitted to the FDA and, based on the decision of the PI, was not submitted to the IRB. | Biological: Ad-RTS-hIL-12 · Drug: Veledimex | Metastatic Breast Cancer | 9 | 2016-07-19actual | 2025-08-28 |
| Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)NCT01555710Overall Survival (OS)Randomized · Open-label · Treatment | Phase 3 | Unknown status | Drug: Carboplatin, Palifosfamide-tris, Etoposide, Carboplatin | Extensive-Stage Small Cell Lung Cancer | 548 | Jun 2015 | 2013-05-21 |
| Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat MelanomaNCT01397708results2025-10-29Number of Participants With Treatment-Emergent Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Biological: INXN-2001 · Drug: INXN-1001 | Melanoma | 26 | Sep 2014actual | 2025-10-29 |
| Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.NCT01703754results2025-08-28Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: After SRC review and Sponsor's halting palifosfamide development, data was collected for Part 1, Arm A. Doses of 80, 100, and 140 mg were used. The SRC reduced 140 mg to 100 mg, then to 80 mg. The study ended with one subject enrolled at 80 mg daily. | Genetic: Ad-RTS-hIL-12 and Veledimex · Drug: Palifosfamide | Breast Cancer Nos Metastatic Recurrent | 12 | 2014-08-07actual | 2025-08-28 |
| A Phase-II Trial of ZIO 101 in Advanced Hepatocellular CarcinomaNCT00423306Response RateNon-randomized · Open-label · Treatment | Phase 2 | Unknown status | Drug: Darinaparsin | HEPATOCELLULAR CARCINOMA | 15 | Dec 2013 | 2013-11-14 |
| A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001bNCT00423644Response RateNon-randomized · Open-label · Treatment | Phase 2 | Unknown status | Drug: Darinaparson | Multiple Myeloma | 17 | Dec 2013 | 2013-11-14 |
| Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid TumorsNCT01340547ECG QTc intervals of patients who receive palifosfamide-trisOpen-label · Treatment | Phase 1 | Unknown status | Drug: palifosfamide-tris, Normal Saline | Advanced Solid Tumors | 24 | Sep 2013 | 2013-07-18 |
| Phase I Study in Advanced Solid TumorsNCT00591292toxicitiesOpen-label · Treatment | Phase 1 | Unknown status | Drug: indibulin | Solid Tumors | 22 | Jun 2013 | 2012-07-19 |
| Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid TumorsNCT00591383toxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Unknown status | Drug: indibulin, erlotinib | Advanced Solid Tumors | 10 | Jun 2013 | 2012-07-19 |
| Phase I Study of Oral Darinaparsin (ZIO-101-C)in Advanced Solid Tumors and Non-Hodgkin's LymphomasNCT00591422ToxicitiesOpen-label · Treatment | Phase 1 | Unknown status | Drug: ZIO-101-C (Darinaparsin) | Advanced Cancer | 23 | Jun 2013 | 2012-07-19 |
| Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and LymphomasNCT00592163toxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Unknown status | Drug: ZIO-101-C (Darinaparsin) | Advanced Solid Tumors, Lymphomas | 20 | Jun 2013 | 2012-07-19 |
| Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid TumorsNCT00726687toxicitiesOpen-label · Treatment | Phase 1/2 | Unknown status | Drug: indibulin, capecitabine | Advanced Solid Tumors | 7 | Jun 2013 | 2012-07-19 |
| Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast CancerNCT01113970Phase I- Maximum Tolerated DoseOpen-label · Treatment | Phase 1/2 | Unknown status | Drug: Indibulin | Metastatic Breast Cancer | 60 | May 2013 | 2013-01-30 |
| Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue SarcomaNCT01168791Progression Free Survival followed by Overall SurvivalRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: doxorubicin in combination with palifosfamide-tris, doxorubicin in combination with placebo | Soft Tissue Sarcoma | 447 | Mar 2013actual | 2013-07-18 |
| Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV MelanomaNCT00815607Physical examinations, vital signs, serum chemistry, urinalysis, hematology, adverse events, and objective response rate, as assessed by diagnostic CT scansOpen-label · Treatment | Phase 1 | Completed | Drug: INXN-1001 · Biological: INXN-3001 | Melanoma | 12 | Jan 2013actual | 2013-07-18 |
| Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With MalignanciesNCT01242072Assess the safety profileOpen-label · Treatment | Phase 1 | Unknown status | Drug: palifosfamide-tris | Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma | 12 | Dec 2012 | 2012-07-18 |
| Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow CancersNCT00421213Response RateNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Darinaparsin | Hematologic Neoplasms, Bone Marrow Neoplasms, Non-Hodgkin's Lymphoma | 50 | Apr 2012actual | 2012-07-19 |
| A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue SarcomaNCT00718484The primary efficacy analysis will be conducted on the intent-to-treat (ITT) population. All attempts will be made to conduct assessment of disease status every 6 weeks until progression of disease or initiating off protocol anti cancer therapies.Randomized · Open-label · Treatment | Phase 2 | Unknown status | Drug: Palifosfamide Tris and Doxorubicin, Doxorubicin | Soft Tissue Sarcoma | 67 | Apr 2012actual | 2014-01-30 |
| Study of Oral Darinaparsin in Patients With Advanced Solid TumorsNCT01139346Determine Toxicity ProfileOpen-label · Treatment | Phase 1 | Completed | Drug: darinaparsin | Advanced Solid Tumors | 12 | Apr 2012actual | 2012-07-19 |
| Safety Study of Darinaparsin in Combination With Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) to Treat LymphomaNCT01139359Define Toxicity profileOpen-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Study enrollment was withdrawn as it is no longer the sponsor's intention to study this indication under this protocol. | Drug: darinaparsin, CHOP | Lymphoma | 0 | Jun 2011 | 2012-07-19 |
| Study of Oral Palifosfamide Tris in Solid TumorsNCT00607711ToxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Suspendedsponsor's stated reason: IND was withdrawn | Drug: oral palifosfamide tris | Advanced Cancer | 20 | Nov 2009 | 2008-05-05 |
| Phase 1 Study of ZIO-201-T in Combination With Doxorubicin in Solid TumorsNCT00608803ToxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ZIO-201-T and doxorubicin | Advanced Cancer | 30 | Jan 2009actual | 2009-09-17 |
| Phase I Study of Indibulin in Patients With Solid TumorsNCT00591136toxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: indibulin | Solid Tumors | 47 | Sep 2008actual | 2012-07-19 |
| A Phase I Trial of ZIO-101 in Solid TumorsNCT00591396toxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ZIO-101 (Darinaparsin) | Solid Tumors | 40 | Jul 2008actual | 2012-07-19 |
| Study of ZIO-201 in Advanced SarcomaNCT00439686toxicitiesNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: ZIO-201 | Advanced Sarcoma | 53 | Jun 2008actual | 2014-01-31 |
| Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) ScansNCT00591890anti-tumor effect on PET ScanNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: indibulin | Advanced Cancer | 20 | Jun 2008actual | 2012-07-19 |
| A Phase I Trial of ZIO-101 in Hematologic CancersNCT00592046Response RateNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ZIO-101 (Darinaparsin) | Acute Leukemia, Chronic Myeloproliferative Disease, Chronic Lymphoproliferative Disease, Multiple Myeloma, Lymphoma, Poor-risk Myelodysplasia (MDS) | 12 | Jun 2008actual | 2012-07-19 |
| A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced CancerNCT00421135toxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ZIO-201 | Advanced Cancer | 30 | Oct 2007actual | 2009-09-17 |
| Study of ZIO-101 in Multiple MyelomaNCT00303199Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03Non-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: ZIO-101 (Darinaparsin) | Multiple Myeloma | 35 | Aug 2007actual | 2012-07-19 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19