Clinical trials: Phase 1
Human Papilloma Virus
HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV
The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.
- Trial name
- NCT03351855
- Testing
- HPV-CTLs
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Speech Sound Disorder
Treatment Targets in Spanish and English Bilingual Speech Intervention
The goal of this clinical trial is to learn which speech treatment targets result in the greatest amount of speech learning in Spanish-English bilingual children with speech sound disorders.
- Trial name
- NCT06416306
- Testing
- Speech Intervention
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Philip Combiths
Cancer
Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells
The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).
- Trial name
- NCT03535246
- Testing
- Engineered Immune Cells
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Cervical Cancer
Engineered Immune Effectors Against Cervical Cancer
The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs).
- Trial name
- NCT03362619
- Testing
- CC-EIEs
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Cancers Which Are CD44v6 Positive
4SCAR-CD44v6 T Cell Therapy Targeting Cancer
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of 4SCAR-CD44v6 T-cell therapy targeting multiple cancers.
- Trial name
- NCT04427449
- Testing
- CD44v6-specific CAR gene-engineered T cells
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Neuroblastoma (NBL), Ewing Sarcoma
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
This study will test a chimeric antigen receptor (CAR) T-cell treatment combined with bevacizumab in children and young adults with relapsed or refractory neuroblastoma, Ewing sarcoma, or osteosarcoma.
- Conditions
- Neuroblastoma (NBL), Ewing Sarcoma, Osteosarcoma
- Trial name
- GD2CART-BEV (NCT07897968)
- Testing
- Chimeric Antigen Receptor (CAR) Therapy Infusion, Bevacizumab (Avastin)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Universität Münster
Ovarian Cancer
Engineered Immune Effectors Against Ovarian Cancer
This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer specific cytotoxic lymphocytes (OC-CTLs) in women.
- Trial name
- NCT03362606
- Testing
- OC-CTLs
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
HIV-1
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in…
- Trial name
- NCT06517693
- Testing
- PGT121.414.LS, VRC07-523LS
- Where
- 19 sites in United States, Brazil and 4 more
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pathogen Infection Covid-19 Infection
Immunity and Safety of Covid-19 Synthetic Minigene Vaccine
In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a…
- Trial name
- NCT04276896
- Testing
- Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
This phase I/II trial studies the side effects and how well nivolumab, fluorouracil, and interferon alpha 2b work for the treatment of fibrolamellar cancer (liver cell cancer) that cannot be removed by surgery (unresectable).
- Conditions
- Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8
- Trial name
- NCT04380545
- Testing
- Fluorouracil, Nivolumab, Recombinant Interferon Alpha 2b-like Protein
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- M.D. Anderson Cancer Center
Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
Background: Some people with cancer have solid tumors. Others have refractory leukemia. This may not go away after treatment. Researchers want to see if a drug called TURALIO(R) can shrink tumors or stop them from growing.
- Conditions
- Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Promyelocytic, Acute, Sarcoma
- Trial name
- NCT02390752
- Testing
- TURALIO(R)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- National Cancer Institute (NCI)
Cancer
Immunotherapy Based on Antigen-specific Immune Effector Cells Targeting Neurofibromatosis or Schwannomatosis
The primary objective of this study is to verify the safety of antigen-specific T cells (CAR-T) and engineered immune effector cytotoxic T cells (EIE) modified by immunoregulatory genes and immune modified dendritic cell vaccine…
- Trial name
- NCT04085159
- Testing
- Antigen-specific T cells CART/CTL and DCvac
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
ECMO
PACE: Prostacyclin AntiCoagulation in ECMO
Extracorporeal membrane oxygenation (ECMO) is a machine that temporarily supports the heart and/or lungs and is a critical rescue therapy for refractory cardiac and respiratory failure in pediatric populations.
- Trial name
- PACE (NCT07837869)
- Testing
- Dose-escalation study of epoprostenol as adjunct anticoagulation in ECMO
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Garrett Keim
Pathogen Infection, EBV Infection
Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections
Epstein Barr Virus (EBV) or Cytomegalovirus (CMV) infection results in significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients.
- Conditions
- Pathogen Infection, EBV Infection, CMV Infection, Adenovirus Infection
- Trial name
- NCT03159364
- Testing
- pathogen-specific CTLs
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma
Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cell therapy against CD7-positive hematological malignancies using CD7 specific CAR T cells.
- Conditions
- T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, Acute Myeloid Leukemia, NK Cell Lymphoma
- Trial name
- NCT04033302
- Testing
- CD7-specific CAR gene-engineered T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
B Cell Malignancies
CD19/22 Bi-specific CAR-T Cell Therapy
The purpose of this study is to assess the feasibility, safety and efficacy of anti-CD19/22 bi-specific CAR-T cell therapy in patients with CD19 and/or CD22 positive B cell malignancies.
- Trial name
- NCT05432882
- Testing
- bi-4SCAR CD19/22 T cells
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Sarcoma, Osteoid Sarcoma
Combination Immunotherapy Targeting Sarcomas
The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged.
- Conditions
- Sarcoma, Osteoid Sarcoma, Ewing Sarcoma
- Trial name
- NCT04433221
- Testing
- Multiple sarcoma-specific CAR-T cells and sarcoma vaccines
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Solid Tumor
GD2/PSMA Bi-specific CAR-T Cell Therapy
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/PSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor.
- Trial name
- NCT05437315
- Testing
- bi-4SCAR GD2/PSMA T cells
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
Transfusion-dependent Beta-Thalassemia
β-Thalassemia Treatment With KL003 Cell Injection
This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with…
- Trial name
- NCT06280378
- Testing
- KL003 Cell Injection Drug Product
- Where
- 2 sites in China
- Volunteers
- 41 people
- Sponsor
- Kanglin Biotechnology (Hangzhou) Co., Ltd.
B Cell Lymphoma (BCL)
Multi-CAR-T Cells Targeting B Cell Lymphomas
This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and…
- Trial name
- NCT04429438
- Testing
- 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
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