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New treatment option for B-Cell Non-Hodgkin's Lymphoma (NHL)
Official title T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
ClinicalTrials.gov ID: NCT06343311
What this study is testing
What is EB103?
EB103 is an investigational medicine, being studied as a potential treatment for b-cell non-hodgkin's lymphoma (nhl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
- people with active cardiac lymphoma involvement which is not responding to treatment
See the full eligibility 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 people 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...
- All people 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
- people 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
- people 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...
- Live vaccine within 3 months prior to planned start of conditioning regimen
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.