Experimental combo therapy shows promise for Tough-to-Treat lymphomas
NCT ID NCT04074746
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 1/2 trial tested a new treatment for people with CD30-positive Hodgkin or non-Hodgkin lymphomas that returned or didn't respond to prior therapy. The treatment combines AFM13, an antibody that targets cancer cells, with natural killer (NK) cells from donated umbilical cord blood. The goal was to find the best dose and check for side effects, while also seeing if the combination can shrink tumors or slow cancer growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AFM13 (a monoclonal antibody) combined with natural killer (NK) cells from donated umbilical cord blood
- What this could lead to
- If it works, this could offer a new treatment option for people with certain lymphomas that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial with only 45 participants, so results may not apply to everyone. Side effects are possible, and the treatment may not work for all patients.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
45 people
The number who actually took part.
- Started
-
Jul 2020
- Finished
-
Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
15 to 75 years
- 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 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: * Patients with a diagnosis of relapsed or refractory classical Hodgkin lymphoma (HL), anaplastic large cell lymphoma (ALCL), peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), mycosis fungoides (MF), or B-cell non-Hodgkin lymphoma with a pre-enrollment tumor biopsy positive for CD30 by immunohistochemistry at \>= 1%. Patients with HL, ALCL and MF must be refractory or intolerant to brentuximab vedotin. * Karnofsky performance status \>= 60%. * Absolute neutrophil count \>= 500/mm\^3 * Platelet count \>= 50,000/mm\^3 * Serum creatinine clearance \>= 50 ml/min, estimated using the Cockcroft-Gault equation. * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN). * Bilirubin =\< 2 x ULN. * Alkaline phosphatase (ALP) =\< 2 x ULN. * Forced expiratory volume in 1 second (FEV1) \>= 50% * Forced vital capacity (FVC) \>= 50% * Carbon monoxide diffusing capability test (DLCO) (corrected for hemoglobin \[Hgb\]) \>= 50% * Left ventricular ejection fraction \>= 40%. * No uncontrolled arrhythmias or symptomatic cardiac disease. * If female of child-bearing potential, must not be pregnant or be breastfeeding and required to have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug. * Note: Urine pregnancy tests that cannot be confirmed as negative, require a confirmatory negative serum pregnancy test. In addition, females of childbearing potential must agree use of a highly effective method of contraception for the course of the study from 14 days prior to the first dose of study drug until 60 days after the last dose of study drug. Non-childbearing potential is defined as: Postmenopausal: defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, FSH measurements indicating post-menopausal status must be documented in patient's medical history. Permanently sterile: documented permanent sterilization e.g. hysterectomy, bilateral salpingectomy and bilateral oophorectomy. If male, surgically sterile or agrees to use a highly effective method of contraception, 14 days prior to the first dose of study drug until 60 days after the last dose of study drug. Exclusion Criteria: * Major surgery \< 4 weeks prior to first dose of study drug. * Any other severe or uncontrolled disease or condition which might increase the risk associated with study participation. * Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer. * Grade \>= 3 non-hematologic toxicity from prior therapy that has not resolved to grade =\< 2. * Active hepatitis B, either active carrier (hepatitis B surface antigen positive \[HBsAg +\]) or viremic (hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \>= 10,000 copies/mL, or \>= 2,000 IU/mL), or hepatitis C (detectable viral load by hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] polymerase chain reaction \[PCR\]). * Active infection requiring parenteral antibiotics. * Human immunodeficiency virus (HIV) infection. * Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved. * Active central nervous system (CNS) involvement (untreated parenchymal brain metastasis or positive cytology of cerebrospinal fluid). * Life expectancy =\< 6 months. * Previous treatment with AFM13.
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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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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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