Estrella Immunopharma (ESLA) FDA Approvals

Estrella Immunopharma's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Estrella Immunopharma (ESLA). Over the past two years, Estrella Immunopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as EB103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

EB103 FDA Regulatory Timeline and Events

EB103 is a drug developed by Estrella Immunopharma for the following indication: ARTEMIS® T-Cell Therapy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Positive Results - February 9,2026

Phase 1

• Drug: EB103
• Announced Date: February 9, 2026
• Indication: ARTEMIS® T-Cell Therapy

Estrella Immunopharma, Inc presented positive STARLIGHT-1 Phase I results at the 2026 ASTCT & CIBMTR Tandem Meetings (American Society for Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research)..

Estrella Immunopharma presented positive Phase I results from the STARLIGHT-1 study at the 2026 ASTCT & CIBMTR Tandem Meetings. The trial evaluates EB103, a CD19-targeted ARTEMIS T‑cell therapy for aggressive B‑cell non‑Hodgkin lymphoma. In the dose escalation portion, EB103 achieved a 100% complete response rate in the high‑dose cohort at Month 1, and all patients who reached complete response remained in that state at the data cutoff. Median duration of complete response has not yet been reached, with current durations ranging from 3 to 18 months. The data also included a complete responder with primary central nervous system lymphoma, a highly aggressive subtype.

Nine patients are reported so far, most high‑risk and ineligible for existing commercial CD19 products. No treatment‑related serious adverse events have been observed to date. Investigators described the responses and manageable toxicity as encouraging, supporting further development of EB103 as a potentially safer, more durable option for a broader group of B‑cell NHL patients.

Results - February 3,2026

Phase 1

• Drug: EB103
• Announced Date: February 3, 2026
• Indication: ARTEMIS® T-Cell Therapy

Estrella Immunopharma, Inc announced its STARLIGHT-1 phase I result will be orally presented at the 2026 ASTCT & CIBMTR Tandem Meetings (American Society for Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research).

Estrella Immunopharma announced that results from its STARLIGHT-1 Phase I study will be presented orally at the 2026 ASTCT & CIBMTR Tandem Meetings. The company said the presentation is a late-breaking oral session and will showcase clinical findings from the ongoing study.

The STARLIGHT-1 study evaluates EB103, a CD19-redirected ARTEMIS® T-cell therapy, in patients with aggressive B-cell Non-Hodgkin Lymphoma (NHL). The upcoming talk will highlight the clinical data gathered so far for EB103 in this patient group, giving attendees an early look at the study’s outcomes and the therapy’s performance in a challenging form of lymphoma.

Estrella is a clinical-stage biopharmaceutical company developing CD19- and CD22-targeted ARTEMIS® T-cell therapies for cancer and autoimmune diseases. For more information, visit the company website.

review - December 4,2025

DSMB Review

• Drug: EB103
• Announced Date: December 4, 2025
• Indication: ARTEMIS® T-Cell Therapy

Estrella Immunopharma, Inc. announced that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose escalation portion of the STARLIGHT-1 trial.

An independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose escalation portion of the STARLIGHT-1 trial and recommended moving the study into Phase II at the Recommended Phase II Dose (RP2D). The DSMB found a favorable safety profile with no treatment-related serious adverse events reported among the nine Phase I patients.

Most patients in the dose escalation were high-risk, including one with central nervous system (CNS) lymphoma. In the high-dose cohort, all evaluable patients achieved a complete response (100%) at Month 1, indicating promising early efficacy alongside the strong safety signal.

The expansion Phase II will further evaluate safety and preliminary efficacy of EB103, Estrella’s CD19-redirected ARTEMIS® T-cell therapy, in relapsed/refractory B-cell non-Hodgkin’s lymphoma. These Phase I results support EB103’s potential to reach higher-risk patients previously ineligible for current CD19 therapies, pending further study.

Dosing Update - November 3,2025

Phase 1

• Drug: EB103
• Announced Date: November 3, 2025
• Indication: ARTEMIS® T-Cell Therapy

Estrella Immunopharma, Inc announced the successful completion of the second dose cohort in Phase I portion of its STARLIGHT-1 Phase I/II clinical trial of EB103, a CD19-redirected ARTEMIS® T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin's Lymphomas (NHL).

Estrella Immunopharma, Inc. announced the successful completion of the second dose cohort in the Phase I part of its STARLIGHT-1 Phase I/II trial for EB103, a CD19-redirected ARTEMIS® T-cell therapy for advanced B-cell non-Hodgkin’s lymphoma. All evaluable patients in this cohort achieved a complete response at Month 1, marking a 100% response rate.

These patients were high-risk and not eligible for existing CD19 products, including one with central nervous system lymphoma. No treatment-related serious adverse events were reported, highlighting EB103’s favorable safety profile. According to CEO Cheng Liu, PhD, the milestone highlights EB103’s potential as a safe, effective option for cancer patients with limited choices.

The cohort included relapsed or refractory patients who had failed multiple therapies. A Data and Safety Monitoring Board will now review the data to set the recommended Phase II dose before moving into the dose expansion phase of STARLIGHT-1.

Provided Update - June 5,2025

Phase 1/2

• Drug: EB103
• Announced Date: June 5, 2025
• Indication: ARTEMIS® T-Cell Therapy

Estrella Immunopharma, Inc announced the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS® T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).

Estrella Immunopharma, Inc. has expanded its STARLIGHT-1 Phase I/II clinical trial by activating a second clinical site at Baylor Research Institute in Dallas, Texas. This site will enroll patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) for a study of EB103, a CD19-Redirected ARTEMIS® T-cell therapy. The trial is designed as an open-label, dose escalation study to assess the safety of EB103 and determine the recommended Phase II dose.

By partnering with a well-respected institution like Baylor Research Institute, Estrella aims to broaden the trial’s reach and accelerate patient access to this new treatment option. The company views this expansion as a key step to developing safer and more effective therapies for patients with advanced NHL, thereby furthering its mission to harness the power of the immune system against cancer.

Enrollment Update - September 27,2024

Phase 1/2

• Drug: EB103
• Announced Date: September 27, 2024
• Indication: ARTEMIS® T-Cell Therapy

Estrella Immunopharma, Inc announced that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial has achieved a complete response (CR) one month after receiving an infusion of EB103 CD19- Redirected ARTEMIS® T Cells.

Estrella Immunopharma, Inc. announced that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial achieved a complete response (CR) just one month after receiving an infusion of EB103 CD19-Redirected ARTEMIS® T Cells. This result means that there are now no detectable signs of disease following the treatment. The patient, diagnosed with follicular lymphoma grade 3A and high-risk symptoms, had relapsed after three previous treatments and was considered high-risk, facing a greater chance of severe side effects from traditional CAR-T therapies. Importantly, the patient experienced no treatment-related serious adverse events such as cytokine release syndrome or neurotoxicity. Estrella is encouraged by these early safety and efficacy results and is focused on developing ARTEMIS® T-cell therapies that could improve on the effectiveness and safety of existing treatments, potentially making these therapies more accessible in a variety of hospital settings.