Engineered killer cells take on Hard-to-Treat lymphoma
NCT ID NCT06334991
First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This early-phase trial is testing a new therapy called CD19 t-haNK, which uses specially engineered natural killer cells to target and destroy cancer cells. It is being tested alone and with the drug rituximab in 10 adults with B-cell non-Hodgkin lymphoma that has come back or not responded to prior treatments. The main goal is to check safety, but researchers will also look at how well the tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD19 t-haNK (an engineered natural killer cell therapy) and rituximab
- What this could lead to
- If successful, this could point toward a new treatment option for people with B-cell non-Hodgkin lymphoma that has not responded to standard therapies.
- What could go wrong
- This is a very early, small Phase 1 trial with only 10 participants, so results may not apply broadly. The main goal is safety, not yet proof of effectiveness, and there are risks like infusion reactions or cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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20 people
The number who actually took part.
- Started
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Aug 2024
- Expected to finish
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Oct 2027
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 years and older
- 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 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines. 3. Histologically documented CD19- and CD20-positive B-cell NHL (excluding primary CNS lymphoma, CLL, and Burkitt lymphoma) 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. Have CD19- and CD20-positive disease confirmed on the diagnostic or repeat biopsy specimen. A minimum of 5% CD19 and CD20 positivity by immunohistochemistry or flow cytometry is required. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Expected survival \> 16 weeks. 6. Stated willingness to comply with study procedures. 7. Able to attend required study visits and return for adequate followup, as required by this protocol. 8. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 5 months after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), and intrauterine devices (IUDs). Exclusion Criteria: 1. Histologically documented primary CNS lymphoma, CLL, Burkitt, or Burkitt-like lymphoma. 2. Known hypersensitivity to sulfa-containing study medication(s), including anaphylactic reaction to sulfa-containing medications. 3. Known allergy to albumin (human) or dimethyl sulfoxide (DMSO). 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 post solid organ transplant who develop high grade lymphomas or leukemias. 10. CD19- and CD20-positive metastases to the CNS, including the parenchyma 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. 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 \[SGOT\]/ALT (SGPT) ≥ 2.5 × ULN. 5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases). 6. Serum creatinine \> 1.6 mg/dL. 7. Each study site should use its institutional ULN to determine eligibility. 14. 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 grade 2 or higher; or serious cardiac arrhythmia requiring medication. 15. Current chronic daily treatment (continuous for \> 3 months) with systemic corticosteroids 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. 16. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications. 17. Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test. 18. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \< 350 cells/μL and a detectable HIV viral load. 19. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive. 20. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin. 21. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 22. Women who are pregnant or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Albert Cellular Therapy
Pretoria, Gauteng, 0044, South Africa
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Dr. Jackie Thomson Inc.
Johannesburg, Gauteng, 2193, South Africa
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FARMOVS
Bloemfontein, Free State, 9301, South Africa
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