Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma (NCT07477366) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma
20 participantsStarted 2026-04
Plain-language summary
Open-Label, Phase 2 Chemotherapy-Free Study ofCD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Indolent Non-Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.
Who can participate
Age range
18 Years – 75 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 to ≤ 75 years old.
. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
. Histologically or flow cytometry documented relapsed/refractory B-cell indolent NHL (iNHL) including but not limited to follicular lymphoma \[FL\]; lymphoplasmacytic lymphoma \[LPL\], also known as Waldenstrom macroglobulinemia \[WM\]; marginal zone lymphoma \[MZL\] with the following specific criteria:
. Have completed ≥ 2 lines of cytotoxic chemotherapy.
. Have received rituximab or another anti-CD20 antibody.
. Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \> 15 mm in the long axis or extranodal lesions \> 10 mm in long and short axis, or bone marrow involvement that is biopsy proven.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
. Stated willingness to comply with study procedures.
Exclusion criteria
. Histologically documented large B-cell lymphomas (eg, diffuse large B-cell lymphoma \[DLBCL\], anaplastic large cell lymphoma \[ALCL\], follicular large cell lymphoma, mantle cell lymphoma), primary central nervous system (CNS) lymphoma, chronic lymphocytic leukemia (CLL), Burkitt and Burkitt-like lymphoma.
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
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
Timeframe: Up to 9 months
2
OS (time from study treatment initiation to death)
. Known hypersensitivity or allergy to any component of the study medications, including sulfa containing study medication(s) (eg, albumin \[human\], dimethyl sulfoxide \[DMSO\]).
. Inadequate organ function, evidenced by the following laboratory results:
. ANC \< 1000 cells/mm3.
. Platelet count \< 100,000 cells/mm3.
. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).