T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) (NCT06343311) | Clinical Trial Compass
RecruitingPhase 1/2
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
United States21 participantsStarted 2024-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* Prior CD19-targeted cellular therapy
* History of Richter's transformation of chronic lymphocytic leukemia (CLL)
* History of another primary malignancy that h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the Dose Limiting Toxicities of EB103.
Timeframe: Time Frame: 28 days
2
Incidence rates of Treatment-Emergent Adverse Events of EB103.
Timeframe: Time Frame: 90 days
3
Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.
Timeframe: Time Frame: 90 days
4
To determine the Recommended Phase II Dose (RP2D) of EB103.