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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 Biopharma, Inc.

About this trial

This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.

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

R/R after ≥ 2 lines of systemic therapy

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

Sequential

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

21 Participants
are divided into 1 treatment group
Group A: EB103Other 1 intervention

Trial outcomes

Primary outcomes

1

To assess the Dose Limiting Toxicities of EB103.

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.

Time frame
Time Frame: 28 days
2

Incidence rates of Treatment-Emergent Adverse Events 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.

Time frame
Time Frame: 90 days
3

Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.

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.

Time frame
Time Frame: 90 days
4

To determine the Recommended Phase II Dose (RP2D) of EB103.

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.

Time frame
Time Frame: 21 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 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.

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 Biopharma, Inc.

Lead sponsor

Eureka Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov
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