Actively Recruiting
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma
Led by ImmunityBio, Inc. · Updated on 2026-04-01
20
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.
CONDITIONS
Official Title
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to understand and provide signed informed consent
- Histologically confirmed CD19- and CD20-positive B-cell Non-Hodgkin Lymphoma
- Active disease after at least 2 lines of cytotoxic chemotherapy
- Previous treatment with rituximab or another anti-CD20 antibody
- Failed autologous transplant or ineligible for autologous transplant
- Measurable disease by Lugano classification within 8 weeks before consent
- At least 5% CD19 and CD20 positivity on recent biopsy
- No central nervous system involvement verified by MRI and lumbar puncture
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Expected survival longer than 12 weeks
- Willing and able to have a central line placed for infusions
- Agree to comply with study procedures and attend required visits
- Agree to use effective contraception if of child-bearing potential
You will not qualify if you...
- Known allergy to any study medication components, including sulfur-containing drugs
- Allergy to human albumin or dimethyl sulfoxide (DMSO)
- Serious uncontrolled diseases that increase risk of treatment complications
- History of significant or active uncontrolled autoimmune disease requiring steroids above 20 mg prednisone daily
- History of allogeneic stem-cell transplant or CAR T therapy within 6 months or ongoing graft-versus-host disease treatment
- Anti-CD19 or anti-CD20 antibody treatment within 4 weeks before cell infusion
- Live vaccine within 6 weeks before starting chemotherapy
- History of organ transplant requiring immunosuppression
- Post solid organ transplant with high-grade lymphoma or leukemia
- Lymphoma involving the central nervous system
- Nonmalignant central nervous system diseases like stroke or epilepsy
- History or active inflammatory bowel disease
- Low blood counts or impaired liver/kidney function as defined by lab tests
- Uncontrolled high blood pressure or significant heart or vascular disease
- Chronic daily systemic corticosteroid use exceeding 10 mg methylprednisolone equivalent
- Use of medications with known adverse interactions with study drugs
- HIV infection with low CD4+ T-cell count
- Chronic hepatitis B infection positive for surface antigen
- Active cancers other than certain skin cancers
- Unable or unwilling to follow study requirements
- Pregnant or breastfeeding women; negative pregnancy test required for women of child-bearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
2
Texas Oncology
Tyler, Texas, United States, 75702
Actively Recruiting
Research Team
M
Mark Nelson
CONTACT
A
Atessa Kiani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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