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 range18 Years – 75 Years

SexALL

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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.
✕. 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).
✕. Aspartate aminotransferase (AST /ALT ≥ 2.5 × ULN.
✕. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).

What they're measuring

ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)

Timeframe: Up to 9 months

OS (time from study treatment initiation to death)

Timeframe: Up to 89 weeks

Trial details

NCT IDNCT07477366

SponsorImmunityBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Andrew Mullins

323-240-2645 andrew.mullins@immunitybio.com

View on ClinicalTrials.gov More Relapsed B-Cell Non-Hodgkin Lymphoma trials