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AzTrials

Recurrent Anaplastic Large Cell LymphomaPhase 1/2NCT04074746

Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

A Phase 1/2 study testing Anti-CD30/CD16A Monoclonal Antibody AFM13, Cyclophosphamide and Fludarabine in people with Recurrent Anaplastic Large Cell Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer [NK] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30 positive Hodgkin lymphoma or non-Hodgkin lymphoma that has come back (recurrent) or does not… Read more about this study

Who is it for?
Ages 15 to 75 years
What is being tested?
Anti-CD30/CD16A Monoclonal Antibody AFM13, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
18 Jul 2020to 23 Sep 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer [NK] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30 positive Hodgkin lymphoma or non-Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as AFM13, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving AFM13 loaded with NK cells followed by AFM13 alone may kill more cancer cells and decrease cancer growth in patients with CD30 positive AFM13-NK Hodgkin and Non-Hodgkin lymphomas.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.
  2. 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.

Being tested
Anti-CD30/CD16A Monoclonal Antibody AFM13, Cyclophosphamide, Fludarabine, Fludarabine Phosphate, Genetically Engineered Lymphocyte Therapy
Medical subject headings
Lymphoma, Large-Cell, Anaplastic, Lymphoma, B-Cell, Mycosis Fungoides, Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-CD30/CD16A Monoclonal Antibody AFM13Biological

    Also called AFM13

    Given IV

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • FludarabineDrug

    Also called Fluradosa

    Given IV

  • Fludarabine PhosphateDrug

    Also called 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara

    Given IV

  • Genetically Engineered Lymphocyte TherapyBiological

    Given AFM13-NK cells IV

Study groups in NCT04074746
Study groupRoleWhat they receive
Treatment (AFM13-NK, AFM13)ExperimentalPatients 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.
Receives: Biological: Anti-CD30/CD16A Monoclonal Antibody AFM13; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Fludarabine Phosphate; Biological: Genetically Engineered Lymphocyte Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerate Dose of AFM13 Umbilical Cord Blood(UCB) Derived Natural Killer(NK) Cells Infused on D=0,D+7,D+14,D+21 for Each Cohort (1x10^6,1x10^7,1x10^8).

    Number of Participants who have experienced Dose-limiting toxicity (DLT) during AFM13-NK cell infusions. DLT will be defined as any related grade 3 or greater non- hematologic toxicity that occurs within 28 days of AFM13-NK infusion

    Measured: 28 days post AFM13-NK cells on D=0 for each Cohort.

Secondary outcomes (1)

  1. Number of Participants That Achieved Complete Response (CR) Post AFM13-NK Cell Infusions.

    Complete Remission requires all of the following:

    Complete metabolic response by PET-CT: Score 1-3. Score 1 (no uptake above the background), Score 2 (uptake is less than or equal to the mediastinal blood pool), or Score 3 (uptake is greater than the mediastinal blood pool but less than or equal to the normal liver) with or without a residual mass on 5 point scale or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in Di.

    Lyric Response Criteria (Appendix 2):

    Complete Response (CR): PET-CT Scores 1-3 Partial Response (PR): PET-CT Scores 4-5 with reduced uptake compared with baseline.

    Progression Disease (PD): PET-CT Scores 4-5 with an increased uptake compared to baseline or new and/or regrowth of measurable lesions.

    Measured: Time Frame: 1 year post AFM13-NK cells on D=0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start18 Jul 2020
  3. Primary completion23 Sep 2025
  4. Study completion23 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074746
Sponsor's protocol ID
2018-1092
Other IDs
NCI-2019-03536, 2018-1092
Status last verified
Sep 2026
First submitted
17 Jun 2019
Last updated
30 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40186077

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anti-CD30/CD16A Monoclonal Antibody AFM13, Cyclophosphamide and Fludarabine in people with Recurrent Anaplastic Large Cell Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerate Dose of AFM13 Umbilical Cord Blood(UCB) Derived Natural Killer(NK) Cells Infused on D=0,D+7,D+14,D+21 for Each Cohort (1x10^6,1x10^7,1x10^8). (time frame: 28 days post AFM13-NK cells on D=0 for each Cohort.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074746, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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