New immune combo aims to fight lymphoma without chemo
NCT ID NCT07477366
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug combination for people with a type of blood cancer called B-cell non-Hodgkin lymphoma that has come back or not responded to treatment. The treatment uses three immune-based drugs (CD19 t-haNK, NAI, and rituximab) without chemotherapy. About 20 adults aged 18 to 75 will take part to see if the combination can shrink tumors and improve survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 to ≤ 75 years old. 2. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. 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: 1. Have completed ≥ 2 lines of cytotoxic chemotherapy. 2. Have received rituximab or another anti-CD20 antibody. 3. 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. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Stated willingness to comply with study procedures. 6. Able to attend required study visits and return for adequate follow-up, as required by this protocol. 7. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative pregnancy test and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive, or an intrauterine device \[IUD\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 12 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 12 months post last dose of study drug). Exclusion Criteria: 1. 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. 2. Known hypersensitivity or allergy to any component of the study medications, including sulfa containing study medication(s) (eg, albumin \[human\], dimethyl sulfoxide \[DMSO\]). 3. Inadequate organ function, evidenced by the following laboratory results: 1. ANC \< 1000 cells/mm3. 2. Platelet count \< 100,000 cells/mm3. 3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia). 4. Aspartate aminotransferase (AST /ALT ≥ 2.5 × ULN. 5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases). 6. Serum creatinine ≥ 2 mg/dL. NOTE: Each study site should use its institutional ULN to determine eligibility 4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications. 5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \> 20 mg of prednisone or equivalent daily. 6. History of allogeneic hematopoietic stem cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy. 7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion. 8. History of receiving allograft organ transplant requiring immunosuppression. 9. Participants that underwent a solid organ transplant who develop high grade lymphomas or leukemias. 10. Metastases to the CNS, including the parenchyma or leptomeninges. 11. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease). 12. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis). 13. Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication. 14. Current chronic daily treatment (continuous for \> 3 months) with systemic corticosteroids as defined as \> 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed. 15. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications. 16. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \< 350 cells/μL and/or a detectable HIV viral load. 17. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive. 18. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin. 19. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 20. Women who are pregnant or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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The official record
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