Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CART84 · 1 trial · 2 indications
Primary Outcome Measure Phase I and Secondary Outcome Measure Phase II: Frequency and severity of adverse events (AEs) and serious AEs (SAEs) occurring after CART84 infusion using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) grading for CRS/ICANS.
Primary Outcome Measure Phase II and Secondary Outcome Measure Phase I: Proportion of patients achieving ORR at day 30 after first infusion of CART84 as assessed by European Leukemia Net (ELN) 2022 guidelines
| Arm | Type | Description |
|---|---|---|
| GYA01 (CART84) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CART84 | DRUG | GYA01 (CART84): autologous cell-based product containing CD3+ T cells transduced with a lentiviral vector expressing an anti-CD84 chimeric antigen receptor (CAR). |
Inclusion Criteria: 1. Age 18 years or older at the time of signing the informed consent. 2. Willing and able to give written, informed consent to the current study. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Diagnosed with AML or T-ALL with ≥5% blasts in BM and/o...
CART84 is an investigational small molecule being developed for acute myeloblastic leukemia, a type of blood cancer. It is also being studied in T-cell leukemia. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
CART84 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research on this investigational oncology drug candidate.
CART84 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by the FDA or other regulatory agencies. The drug is currently being evaluated in an early-stage clinical trial to assess its safety and efficacy.
CART84 is being studied in a Phase 1 clinical trial with the identifier NCT07471789. This trial is recruiting patients with relapsed or refractory acute myeloid leukemia and T-cell acute lymphoblastic leukemia. The study is being conducted in Spain and aims to enroll 33 participants.
Yes, CART84 is also known as GYA01. The clinical trial NCT07471789 refers to the drug as GYA01 (CART84) in its title, indicating that both names refer to the same investigational drug candidate.