RECRUITING

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

Conditions

B-Cell Non-Hodgkin's Lymphoma (NHL)Lymphoma, Non-Hodgkins Lymphomas Non-Hodgkin's B-Cell Non-Hodgkin Lymphoma Non-Hodgkin's Lymphoma Large B-Cell Lymphoma Lymphoma, Non-Hodgkin's, Adult Lymphoma Refractory Non-Hodgkin Lymphoma Relapsed Non-Hodgkin Lymphoma Lymphoma, Non-Hodgkin HIV Associated Lymphoma CNS Lymphoma High-grade B-cell Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma B-Cell Non-Hodgkin's Lymphoma NHL HIV Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (NHL)

Quick Facts

Study Start:2024-06-01

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06343311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R/R after ≥ 1 lines of systemic therapy * Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT) * For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens * All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an: * Anti-CD20 monoclonal antibody AND * An anthracycline-containing chemotherapy regimen * Positron emission tomography (PET)-positive disease according to Cheson 2014 * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Toxicities due to prior therapy must be stable and recovered to Grade 1 or less	* 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 * CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms * Subjects with active cardiac lymphoma involvement which is not responding to treatment * History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent * Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled. * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years * History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents * Venous thrombosis or embolism not managed on a stable regimen of anticoagulation * Autologous HSCT within 3 months of informed consent * Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening * Live vaccine within 3 months prior to planned start of conditioning regimen

Inclusion Criteria

Exclusion 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
* For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R/R after ≥ 1 lines of systemic therapy
* Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)
* For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens
* All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:
* Anti-CD20 monoclonal antibody AND
* An anthracycline-containing chemotherapy regimen
* Positron emission tomography (PET)-positive disease according to Cheson 2014
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Toxicities due to prior therapy must be stable and recovered to Grade 1 or less

* 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
* CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms
* Subjects with active cardiac lymphoma involvement which is not responding to treatment
* History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent
* Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
* History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
* History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents
* Venous thrombosis or embolism not managed on a stable regimen of anticoagulation
* Autologous HSCT within 3 months of informed consent
* Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening
* Live vaccine within 3 months prior to planned start of conditioning regimen

Contacts and Locations

Study Contact

Teresa Klask, MBA

CONTACT

925-949-9314

teresa.klask@eurekainc.com

Pei Wang, PhD

CONTACT

510-654-7045

pei.wang@eurekainc.com

Principal Investigator

Pei Wang, PhD

STUDY_DIRECTOR

Eureka Therapeutics Inc.

Study Locations (Sites)

University of California, Davis

Sacramento, California, 95817

United States

Collaborators and Investigators

Sponsor: Estrella Biopharma, Inc.

Pei Wang, PhD, STUDY_DIRECTOR, Eureka Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-06-01

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

B-Cell Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
NHL
Lymphoma
Large B-Cell Lymphoma
Refractory Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
HIV Lymphoma
CNS Lymphoma
High-grade B-cell Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma

Additional Relevant MeSH Terms

B-Cell Non-Hodgkin's Lymphoma (NHL)
Lymphoma, Non-Hodgkins
Lymphomas Non-Hodgkin's B-Cell
Non-Hodgkin Lymphoma
Non-Hodgkin's Lymphoma
Large B-Cell Lymphoma
Lymphoma, Non-Hodgkin's, Adult
Lymphoma
Refractory Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Lymphoma, Non-Hodgkin
HIV Associated Lymphoma
CNS Lymphoma
High-grade B-cell Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma