A Phase 1 Open-label Preliminary Pharmacokinetics (PK)and Safety Study of CLN-049 (An fms-like tyrosine kinase 3 [FLT3] x cluster of differentiation 3 [CD3] bispecific T cell engager) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Phase 1, Open-label, Preliminary Pharmacokinetics (PK)and Safety Study of CLN-049 (An fms-like tyrosine kinase 3 [FLT3] x cluster of differentiation 3 [CD3] bispecific T cell engager) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Phase 1 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of BL-M07D1 in Subjects with HER2 Expressing Advanced Malignant Solid Tumors
This is a multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and initial efficacy of BL-M07D1 in subjects with metastatic or unresectable HER2-expressing cancers. This study has three parts: dose escalation, dose finding and dose expansion. This study will determine the MTD (if reached), maximum administered dose (MAD), and RDE. The dose and dosing schedule used for this study were based on nonclinical studies and a Phase 1 Study, BL-M07D1-101, conducted in China.
A phase 1 placebo-controlled dose-escalation study of the safety pharmacokinetics and antiviral activity of a potent neutralizing monoclonal antibody in individuals with chronic hepatitis B infection
The purpose of this research study is to evaluate the safety and tolerability of intravenous(through a vein in your arm) infusions of a new drug. The drug, Hep B mAb19, is an antibodyand was discovered in a laboratory at Rockefeller University. An antibody is a substance thatthe body makes in response to an infection. This antibody is designed to block HBV frominfecting new cells or eliminate HBV-infected cells. This will be the first time the drug isused in people.
A Phase 1 Randomized Double-Blind Study to Evaluate the Safety and Tolerability of a Vaccine against E. coli in Healthy Adults
This is a Phase 1, randomized, observer-blind study to evaluate the safety, and tolerability, of FimH modRNA and O25b conjugate (with or without adjuvant) vaccine against E coli in healthy adults.
A Phase 1 Study of GC012F a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Early-Line Treatment in Subjects with Multiple Myeloma
This is a Phase 1 study testing if the study medicine AZD0120 (Chimeric Antigen Receptor T-cell (CAR T) Therapy) is safe, effective, and has fewer side effects in treating adult patients with Early Line Multiple Myeloma (ELMM). CAR T-cell therapy is a type of treatment that uses patient's own T cells, which are genetically modified to fight his/her cancer. The study team will collect each patient’s T cells, called peripheral blood mononuclear cells (PBMC), to generate AZD0120. Each patient will then receive a medicine called lymphodepletion treatment for 3 days. Following this, after 5-7 days, all patients will receive a single injection of the study medicine AZD0120. All the patients will be divided into two groups. For group 1, the study team will include three patients at a time to receive the study medicine. They will gradually increase the dose of the study medicine for each new group until they find out the dose that is safe and works well for the patients. For group 2, the study team will include more patients to receive the study medicine at a dose that worked well. All patients will have their blood samples taken to see how their body is handling the study treatment and if the study treatment is working well. Special scans will be taken for all patients to see how their cancer is responding to the study treatment. All patients will be closely monitored for safety and any side effects and will be followed for up to 2 years after AZD0120 injection to ensure ongoing safety.
A Phase 1 Study of ICP-248 in Combination with Azacitidine for the Treatment in Patients with Myeloid Malignancies
This is a phase 1, open-label, multicenter study with two parts that will assess the safety profile, PK profile, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with myeloid malignancies.
A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors
This is a study testing MOMA-313, a drug that blocks a protein called DNA polymerase theta (Pol?) for prostate cancer with a genetic feature called homologous repair deficiency, most commonly with mutation in the gene BRCA2. The drug is being tested by itself or combined with another drug called olaparib, which blocks a different protein (PARP). There are two groups of patients: one group will get MOMA-313 alone, and the other group will get both MOMA-313 and olaparib. In the first group, doctors will test different doses to find the best amount that is effective and with the least amount of side effects to give patients. If patients do well but don't have a strong response to MOMA-313 alone, they may be switched to get both drugs together. The study will also look at how food ate by a patient affects MOMA-313 and how it interacts with olaparib.
A Phase 1 Study of NKX019 a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy in Subjects with Lupus Nephritis
The purpose of this study is to investigate NKX019, which is made from one type of white blood cell called a natural killer (NK) cell. Those cells are present in healthy subjects and in patients. The NK cells used in NKX019 are taken from the blood of healthy donors. These cells are then modified so that they can identify and remove cells which have a marker on their surface called CD19. CD19 is present on the surface of almost all B cells (another type of immune cell). Studies have shown that by removing these B cells, the harmful antibodies that attack the body’s own tissues in lupus will also be eliminated. This could potentially slow or stop progression of lupus in the body’s organs.
A Phase 1 Study of the Polymerase Theta Inhibitor Novobiocin in BRCA-Mutant and Other DNA Damage Repair-Deficient Solid Tumors
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of novobiocin administered on a 5-days on/2-days off schedule in patients with solid tumors carrying homologous recombination (HR) or DNA damage repair (DDR) alterations that are PARP inhibitor- naïve or -resistant. Standard hematological and non-hematologic parameters, scored using CTCAE v.5.0, will be used to define dose-limiting toxicity (DLT).
A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS
The purpose of this study is to test the safety of a study drug called TJ033721. The study will test different dose levels to find out what effects, both good and/or bad, the study treatment has on you and your solid tumor. The study drug, TJ033721, is investigational and has been tested in animals, but not yet in people. This means it has not been approved for commercial use by the United States Food and Drug Administration (FDA).This study tests up to 8 different doses of the study drug to see which dose is safe in people. The dose you receive will depend on when you start the study. The study drug’s effects will be measured by testing samples of your blood, scanning your tumor area, and in some cases taking a biopsy of your tumor. The study staff will also watch for physical changes after you are given the study drug.