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EB103

Phase 1

B-Cell Non-Hodgkin's Lymphoma (NHL) | Monoclonal antibody | Oncology |Estrella Immunopharma, Inc.|Last Updated: Aug 7, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06343311T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)PHASE1 RECRUITING 21Jun 1, 2024Dec 31, 2027Aug 7, 20252 United States
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Study Endpoints
Primary Endpoints
To assess the Dose Limiting Toxicities of EB103.
Time Frame: 28 days

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.

Incidence rates of Treatment-Emergent Adverse Events of EB103.
Time Frame: 90 days

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.

Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.
Time Frame: 90 days

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.

To determine the Recommended Phase II Dose (RP2D) of EB103.
Time Frame: 21 months

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.

Secondary Endpoints
To assess the Overall Response Rate of EB103 in our study subject population.
Time Frame: Up to 2 years
To assess the Disease Control Rate of EB103 in our study subject population.
Time Frame: Up to 2 years
To assess the Duration of Response of EB103 in our study subject population.
Time Frame: Up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EB103OTHERApproximately six (6) subjects will be treated to determine the RP2D. At the designated RP2D, approximately fifteen (15) additional subjects will be treated.
Interventions
NameTypeDescription
EB103BIOLOGICALEB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

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 ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06343311primaryCompletionDate: changed
LOWMay 24, 2026NCT06343311studyFirstPostDate: changed