B-Cell Non-Hodgkin's Lymphoma study: EB103
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 autologous T‑cell therapy being studied for B‑cell non‑Hodgkin lymphoma.
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
- The study aims to determine whether EB103 is safe and can help patients whose lymphoma has returned or not responded to other treatments, especially those with HIV‑related, CNS, or high‑grade B‑cell lymphoma.
- Who it's for
- Adults with relapsed or refractory B‑cell non‑Hodgkin lymphoma, including HIV‑associated, CNS, high‑grade, or large B‑cell types, who cannot receive a transplant.
- What's involved
- Participants receive EB103 T‑cell therapy and attend clinic visits and tests to monitor safety and response.
- Time commitment
- The study lasts about two years, with regular visits during the first six months and follow‑up visits every three months thereafter.
- 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 disease
- Progressive disease (PD) as best response to any line of chemoimmunotherapy
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
- Clinical or radiological evidence of impending brain herniation or significant mass effect
- Those with PCNSL or secondary CNS lymphoma who have previously received whole brain radiotherapy (WBRT)
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 disease
- Progressive disease (PD) as best response to any line of chemoimmunotherapy
- Stable disease (SD) or partial response (PR) as best response to ≥ 4 cycles of first-line chemoimmunotherapy or to ≥ 2 cycles of later-line chemoimmunotherapy
- Relapse ≤ 12 months of first-line chemoimmunotherapy
- Intolerance of high-dose methotrexate (HD-MTX) induction therapy
- people ineligible for autologous hematopoietic stem cell transplantation (Auto HSCT) consolidation of HD-MTX-based induction
- people who have relapsed at any time after Auto HSCT
- Diagnosis and disease assessment
- For Non-CNS B-cell NHL Positron emission tomography (PET)-positive disease assessment according to Cheson 2014
- For PCNSL or secondary CNS lymphoma shall have the initial diagnosis confirmed by International PCNSL Collaborative Group (IPCG) criteria according to Abrey 2005; Barajas, 2021; Hoang-Xuan 2023.
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Toxicities due to prior therapy must be stable and recovered to Grade 1 or less
- Female people of childbearing potential must have a negative serum pregnancy test within 7 days of informed consent and prior to starting conditioning chemotherapy.
- 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
- Clinical or radiological evidence of impending brain herniation or significant mass effect
- Those with PCNSL or secondary CNS lymphoma who have previously received whole brain radiotherapy (WBRT)
- 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
- 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...
- Live vaccine within 3 months prior to planned start of conditioning regimen
- Inability to adhere to all required washout periods for agents and therapies prior to leukapheresis AND prior to starting conditioning chemotherapy
- Female people of childbearing potential who are pregnant or breastfeeding; people must agree to abstain from breastfeeding during study participation and for ≥ 1 year after lymphodepleting chemotherapy
- In the Investigator's judgement, the subject is unlikely, unable, or unwilling to complete protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
- All genders who are not willing to use acceptable methods of contraception from the time of informed consent through 12 months after EB103 T-cell infusion
- Any medical condition that, in the Investigator's or the Sponsor's opinion, would impose excessive risk to the subject or ability to assess effect of the study drug.
The study team makes the final eligibility decision.
Where it is enrolling
- Sacramento, California, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, 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, but 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?
This study is enrolling now at Sacramento, California, United States; Cleveland, Ohio, United States; Portland, Oregon, United States; Dallas, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.