Clinical trials: TCR-T Cells
Neoplasms
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
- Trial name
- IGNYTE-ESO (NCT03967223)
- Testing
- Letetresgene autoleucel (lete-cel, GSK3377794), Fludarabine, Cyclophosphamide
- Where
- 38 sites in United States, Canada and 5 more
- Volunteers
- 103 people
- Sponsor
- USWM CT, LLC
Hepatitis B, Chronic
Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB).
- Trial name
- NCT05867056
- Testing
- IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses, HBV HCC Module MAD
- Where
- 15 sites in United States, Australia and 7 more
- Sponsor
- Immunocore Ltd
Recurrent Hepatocellular Carcinoma
A Study of TCR-Redirected T Cell Infusion in Subject With Recurrent HBV-related HCC Post Liver Transplantation
Hepatocellular carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 10 patients with Hepatitis B virus (HBV) related HCC who underwent liver…
- Trial name
- NCT02719782
- Testing
- Biological: TCR-T
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lion TCR Pte. Ltd.
Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose.
- Trial name
- NCT03912831
- Testing
- KITE-439, Cyclophosphamide, Fludarabine
- Where
- 9 sites in United States
- Volunteers
- 8 people
- Sponsor
- Gilead Sciences
Solid Tumor, Cancer
TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)
The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).
- Conditions
- Solid Tumor, Cancer, Recurrent Solid Tumors, Refractory Solid Tumors
- Trial name
- ACTengine (NCT03247309)
- Testing
- IMA201 Product, IMADetect®
- Where
- 5 sites in United States, Germany
- Volunteers
- 7 people
- Sponsor
- Immatics US, Inc.
HCC, Hepatitis B Virus Related Hepatocellular Carcinoma
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
- Conditions
- HCC, Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma
- Trial name
- NCT06617000
- Testing
- SCG101
- Where
- 7 sites in China
- Volunteers
- 38 people
- Sponsor
- SCG Cell Therapy Pte. Ltd.
Neoplasms
Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) in participants with metastatic NSCLC.
- Trial name
- NCT02588612
- Testing
- letetresgene autoleucel (GSK3377794), Cyclophosphamide, Fludarabine
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- GlaxoSmithKline
Renal Clear Cell Carcinoma
Tissue Collection to ID TCRs From Renal Clear Cell Carcinoma Patients Responding to Immune Checkpoint Inhibitors
T Cell Receptor-engineered T-cell therapy (TCR T-cell therapy) offers a potentially transformative approach to treating cancer, but is currently limited by the lack of known targets (Maus and June, 2016; Ping et al., 2018).
- Trial name
- NCT04680416
- Where
- United States
- Sponsor
- TScan Therapeutics, Inc.
Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation
This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of…
- Conditions
- Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Adenocarcinoma, Lung Adenocarcinoma
- Trial name
- NCT07875920
- Testing
- Fludarabine, Cyclophosphamide, NW-301V
- Where
- 2 sites in China
- Volunteers
- 66 people
- Sponsor
- Neowise Biotechnology
Cancer, Solid Tumor
ACTolog in Patients With Solid Cancers
The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets.
- Trial name
- ACTolog (NCT02876510)
- Testing
- Fludarabine, Cyclophosphamide, IMA101 product
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Immatics US, Inc.
B-cell Malignancies
A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
- Trial name
- TITANium (NCT06542250)
- Testing
- AZD5492
- Where
- 31 sites in United States, Australia and 8 more
- Volunteers
- 174 people
- Sponsor
- AstraZeneca
Non-muscle Invasive Bladder Cancer
A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder…
- Trial name
- NCT01625260
- Testing
- ALT-801, Gemcitabine
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Altor BioScience
Neoplasms
Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma
This trial will evaluate safety, tolerability, and efficacy of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with relapsed and refractory multiple myeloma.
- Trial name
- NCT03168438
- Testing
- Letetresgene autoleucel, Letetresgene autoleucel with pembrolizumab, Fludarabine
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab…
- Trial name
- START-002 (NCT06827613)
- Testing
- STAR0602, Sacituzumab Govitecan (SG)
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Marengo Therapeutics, Inc.
Acute Leukemia, Myelodysplastic Syndrome
Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
- Trial name
- NCT07573111
- Testing
- QUAIL-100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Laguna Biotherapeutics, Inc.
Cervical Cancer, Anal Cancer
CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers
A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A*02:01+ Subjects HPV16 positive advanced cervical, anal, or…
- Conditions
- Cervical Cancer, Anal Cancer, Head and Neck Cancers, Other Solid Tumors
- Trial name
- NCT06358053
- Testing
- CRTE7A2-01 TCR-T cell therapy
- Volunteers
- 24 people
- Sponsor
- Corregene Biotechnology Co., Ltd
Uveal Melanoma
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.
- Trial name
- NCT03070392
- Testing
- IMCgp100, Dacarbazine, Ipilimumab
- Where
- 57 sites in United States, Australia and 12 more
- Volunteers
- 378 people
- Sponsor
- Immunocore Ltd
Advanced Melanoma
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of…
- Trial name
- NCT05549297
- Testing
- Tebentafusp, Tebentafusp with Pembrolizumab, Investigators Choice
- Where
- 82 sites in United States, Australia and 10 more
- Volunteers
- 540 people
- Sponsor
- Immunocore Ltd
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity…
- Trial name
- ALLOHA-2 (NCT07702578)
- Testing
- TSC-101, Control
- Where
- 26 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, Inc.
AML, ALL
A Long Term Follow-up Study of TScan TCR-T Products
The purpose of this Long-Term Follow-Up (LTFU) study is to monitor participants who have previously received TSC-100 or TSC-101 TCR-T therapies in the TSCAN-001 study.
- Conditions
- AML, ALL, MDS
- Trial name
- LTFU (NCT06976736)
- Testing
- Observational
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- TScan Therapeutics, Inc.