Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas
NCT ID: NCT04074746
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2020-07-18
2025-09-22
Brief Summary
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Detailed Description
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I. To establish the safety and recommended phase II dose of umbilical cord blood (CB)-derived natural killer (NK) cells preloaded with the bispecific antibody AFM13 (AFM13-NK), followed by intravenous anti-CD30/CD16A monoclonal antibody AFM13 (AFM13) in patients with refractory/relapsed CD30-positive lymphoid malignancies based on incidence of dose limiting toxicities (DLTs) per dose level. (Phase I) II. To assess the activity of umbilical cord blood (CB)-derived natural killer (NK) cells preloaded with the bispecific antibody AFM13 (AFM13- NK), followed by intravenous AFM13 in patients with refractory/relapsed CD30-positive lymphoid malignancies. based on overall response rate (ORR), complete response (CR) rate and partial response (PR) rate. (Phase II)
SECONDARY OBJECTIVES:
I. To evaluate the duration of response. II. To evaluate the event-free survival (EFS) rate. III. To evaluate the overall survival (OS) time. IV. To quantify the persistence of infused donor CB AFM13-NK cells in the recipient.
V. To conduct comprehensive immune reconstitution studies.
OUTLINE: This is a dose-escalation study of AFM13-NK.
Patients receive standard of care fludarabine intravenously (IV) over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21.
After completion of study treatment, patients are followed up at 28 days, 8 weeks, 100 and 180 days and then every 3-6 months for 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (AFM13-NK, AFM13)
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21.
Anti-CD30/CD16A Monoclonal Antibody AFM13
Given IV
Cyclophosphamide
Given IV
Fludarabine
Given IV
Fludarabine Phosphate
Given IV
Genetically Engineered Lymphocyte Therapy
Given AFM13-NK cells IV
Interventions
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Anti-CD30/CD16A Monoclonal Antibody AFM13
Given IV
Cyclophosphamide
Given IV
Fludarabine
Given IV
Fludarabine Phosphate
Given IV
Genetically Engineered Lymphocyte Therapy
Given AFM13-NK cells IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
75 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yago L Nieto
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Nieto Y, Banerjee P, Kaur I, Basar R, Li Y, Daher M, Rafei H, Kerbauy LN, Kaplan M, Marin D, Griffin L, Barnett M, Bassett R, Uprety N, Shrestha R, Silva FR, Islam S, Ganesh C, Borneo Z, Ramdial J, Ramirez A, Hosing C, Alousi A, Popat U, Qazilbash M, Ahmed S, Iyer S, Sainz TP, Vega F, Fowlkes NW, Alexis K, Emig M, Harstrick A, Overesch A, Shpall EJ, Rezvani K. Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a phase 1 trial. Nat Med. 2025 Jun;31(6):1987-1993. doi: 10.1038/s41591-025-03640-8. Epub 2025 Apr 4.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-03536
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-1092
Identifier Type: OTHER
Identifier Source: secondary_id
2018-1092
Identifier Type: -
Identifier Source: org_study_id
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