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T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

ConditionsB-Cell Non-Hodgkin's Lymphoma (NHL)Lymphoma, Non-HodgkinsLymphomas Non-Hodgkin's B-CellNon-Hodgkin LymphomaNon-Hodgkin's LymphomaLarge B-Cell LymphomaLymphoma, Non-Hodgkin's, AdultLymphomaRefractory Non-Hodgkin LymphomaRelapsed Non-Hodgkin LymphomaLymphoma, Non-HodgkinHIV Associated LymphomaCNS LymphomaHigh-grade B-cell LymphomaRefractory B-Cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEstrella Immunopharma, Inc.

About this trial

This is an open-label, multi-center, Phase 1/2 clinical trial evaluating the safety and effectiveness of EB103 in R/R B-cell NHL patients with the highest unmet medical needs, such as Human Immunodeficiency Virus (HIV)-associated lymphoma, primary and secondary central nervous system (CNS) lymphoma, and a wide range of high-grade B-cell lymphomas (HGBLs), as well as R/R large B-cell lymphoma (LBCL) patients ineligible for autologous transplant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 disease

Disqualifiers

Prior CD19-targeted cellular therapy

History of Richter's transformation of chronic lymphocytic leukemia (CLL)

History of another primary malignancy that has not been in remission for ≥ 2 years.

History or presence of clinically relevant Central Nervous System (CNS) pathology

Trial design

Design model

Single group

Treatments tested in this trial

  • EB103

    Biological/Vaccine

    EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: EB103Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the safety and tolerability of EB103.

Type, frequency, and severity of adverse events (AEs), including treatment-emergent AEs (TEAEs), treatment-related AEs (TRAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), clinically significant laboratory abnormalities recorded as AEs, and AEs leading to permanent discontinuation.

Time frame
Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years
2

To determine the Recommended Phase II Dose (RP2D) of EB103 (in Phase 1, Dose Escalation)

RP2D based on maximum tolerated dose (MTD) (if reached), overall safety, preliminary efficacy, and manufacturing capability.

Time frame
Time Frame: 16 months

Secondary outcomes

1

To assess the Overall Response Rate of EB103 in our study subject population.

The Overall Response Rate (ORR), defined as the proportion of subjects with a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) will be assessed.

Time frame
Time Frame: Up to 2 years
2

To assess the Disease Control Rate of EB103 in our study subject population.

The Disease Control Rate (DCR), defined as the proportion of subjects with BOR of either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) will be assessed.

Time frame
Time Frame: Up to 2 years
3

To assess the Duration of Response and duration of complete response of EB103 in our study subject population.

The Duration of Response (DOR), defined as the time from first response to Progressive Disease (PD) or death will be assessed. The duration of complete response (DOCR), defined as the time from CR to PD or death.

Time frame
Time Frame: Up to 2 years
4

To assess the Progression-Free Survival rate of EB103 in our study subject population.

The Progression-Free Survival (PFS), defined as the time from EB103 infusion to PD or death will be assessed.

Time frame
Time Frame: Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Estrella Immunopharma, Inc.

Lead sponsor

Eureka Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov
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