Actively Recruiting

Phase 1
Age: 18Years - 99Years
All Genders
NCT06334991

Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

Led by ImmunityBio, Inc. · Updated on 2026-05-04

10

Participants Needed

3

Research Sites

183 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 combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL).

CONDITIONS

Official Title

Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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, excluding primary CNS lymphoma, CLL, and Burkitt lymphoma
  • Completed at least 2 lines of cytotoxic chemotherapy
  • Prior treatment with rituximab or another anti-CD20 antibody
  • Measurable disease by Lugano classification within 8 weeks before consent
  • CD19 and CD20 positivity of at least 5% confirmed by biopsy or flow cytometry
  • ECOG performance status of 0 to 1
  • Expected survival of more than 16 weeks
  • Willingness to comply with study procedures
  • Ability to attend all required study visits and follow-up
  • Agreement to use effective contraception during the study and for 5 months after last dose (for females of childbearing potential and nonsterile males)
Not Eligible

You will not qualify if you...

  • Diagnosis of primary CNS lymphoma, chronic lymphocytic leukemia (CLL), Burkitt or Burkitt-like lymphoma
  • Known allergy to sulfa-containing medications or history of anaphylaxis to sulfa
  • Allergy to human albumin or dimethyl sulfoxide (DMSO)
  • Serious uncontrolled diseases that increase risk of treatment complications
  • Significant autoimmune disease or active uncontrolled autoimmune conditions requiring high-dose steroids
  • History of allogeneic hematopoietic stem-cell transplant needing ongoing graft-versus-host disease therapy
  • Anti-CD20 antibody treatment within 2 weeks before cell infusion
  • History of organ transplant requiring immunosuppression
  • Development of high-grade lymphomas or leukemias after solid organ transplant
  • CD19- and CD20-positive metastases to the central nervous system
  • Nonmalignant central nervous system diseases such as stroke or epilepsy
  • History or active inflammatory bowel disease
  • Inadequate organ function based on specific blood count and liver/kidney test thresholds
  • Uncontrolled hypertension or serious cardiovascular conditions within 6 months prior to treatment
  • Chronic daily systemic corticosteroid use over 3 months at doses above 20 mg prednisone equivalent
  • Use of medications with known adverse interactions with study drugs
  • Positive tuberculosis test
  • HIV infection with low CD4 count and detectable viral load
  • Active hepatitis B infection
  • Concurrent active cancers other than certain skin cancers
  • Inability or unwillingness to follow study protocol
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

FARMOVS

Bloemfontein, Free State, South Africa, 9301

Actively Recruiting

2

Dr. Jackie Thomson Inc.

Johannesburg, Gauteng, South Africa, 2193

Actively Recruiting

3

Albert Cellular Therapy

Pretoria, Gauteng, South Africa, 0044

Actively Recruiting

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Research Team

K

Kayleigh Russell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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