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Engineered killer cells take on Hard-to-Treat lymphoma

NCT ID NCT06334991

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Albert Cellular Therapy

    Pretoria, Gauteng, 0044, South Africa

  • Dr. Jackie Thomson Inc.

    Johannesburg, Gauteng, 2193, South Africa

  • FARMOVS

    Bloemfontein, Free State, 9301, South Africa

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