Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EB103 · 1 trial · 15 indications
The incidence of Dose Limiting Toxicities (DLTs) that occur within 28 days following EB103 T-cell infusion will be assessed. A DLT consists of any adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, concomitant medication, or intercurrent illness that occurs within 28 days following EB103 T-cell infusion and meets specified criteria as outline in the clinical protocol. The type, frequency, and severity of each DLT, AE, and abnormal laboratory value will be documented to assess the safety and tolerability of EB103.
The type, frequency, and severity of Treatment-Emergent Adverse Events (TEAEs) will be assessed and includes an AE that starts any time from initiation of EB103 administration through and including 90 days after EB103 administration. Listing and summaries will be prepared for the following type of events: TEAEs, SAEs, Grade 3 or higher AEs, treatment related AEs (conditioning chemotherapy, protocol-mandated procedures, or EB103), and AEs leading to death. AESIs, including but not limited to acute infusion reaction, CRS, ICANS, prolonged cytopenia, TLS, MAS/HLH, SPM, and hypogammaglobulinemia.
The type, frequency, and severity after Treatment-Emergent Laboratory Abnormalities will be assessed and includes a laboratory abnormality that, compared to baseline, worsens by at least one grade with 90 days after EB103 administration.
The RP2D will be determined by the study Dose Escalation Committee (DEC) and chosen based on the maximum tolerated dose (MTD) but will not exceed the MTD and the maximum administered dose (MAD). The RP2D will also be based on the manufacturing capability.
| Arm | Type | Description |
|---|---|---|
| EB103 | OTHER | Approximately six (6) subjects will be treated to determine the RP2D. At the designated RP2D, approximately fifteen (15) additional subjects will be treated. |
| Name | Type | Description |
|---|---|---|
| EB103 | BIOLOGICAL | EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene. |
Inclusion Criteria: * Age 18 years or older at the time of informed consent * Histologically confirmed R/R B-cell non-Hodgkin's lymphoma (NHL) * Adequate organ function * Relapsed or refractory (R/R) disease defined as ONE OR MORE of the following: * R/R after ≥ 2 lines of systemic therapy ...
EB103 is an investigational T-cell therapy being developed for adults with relapsed or refractory B-Cell Non-Hodgkin's Lymphoma (NHL). It is currently in Phase 1 clinical development and has not been approved by the FDA. The therapy is being studied in a single-arm, uncontrolled clinical trial in the United States.
EB103 targets CD19, a protein expressed on B cells. By directing T cells against CD19-positive cells, the therapy is designed to attack malignant B cells involved in B-Cell Non-Hodgkin's Lymphoma. It is a monoclonal antibody-based T-cell therapy, though it remains investigational and is not yet approved.
EB103 is being developed by Estrella Immunopharma, Inc., a biopharmaceutical company traded under the ticker symbol ESLA. The company is conducting a Phase 1 clinical trial of EB103 in the United States for adults with relapsed or refractory B-Cell Non-Hodgkin's Lymphoma.
EB103 is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The ongoing Phase 1 trial is recruiting participants with relapsed or refractory B-Cell Non-Hodgkin's Lymphoma and is designed as an uncontrolled, non-randomized study.
EB103 is being evaluated in a single Phase 1 clinical trial registered as NCT06343311. The trial, titled "T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)," is currently recruiting in the United States with a planned enrollment of 21 participants aged 18 years and older.