Who is sponsoring NCT04074746?

NCT04074746 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT04074746?

Interventions in NCT04074746: Anti-CD30/CD16A Monoclonal Antibody AFM13, Cyclophosphamide, Fludarabine, Fludarabine Phosphate, Genetically Engineered Lymphocyte Therapy.

What condition does NCT04074746 study?

NCT04074746 studies Recurrent Anaplastic Large Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Classic Hodgkin Lymphoma, Recurrent Mycosis Fungoides, Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified, Refractory Anaplastic Large Cell Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma, Refractory Mycosis Fungoides, Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified.

Is NCT04074746 still recruiting?

NCT04074746 is currently completed. Last updated 30 September 2025.

Last reviewed 2025-09-30 · How we verify

NCT04074746

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Last updated 30 September 2025

What this trial tests

Phase 1, PHASE2 trial testing Anti-CD30/CD16A Monoclonal Antibody AFM13 in Recurrent Anaplastic Large Cell Lymphoma in 45 participants. Completed in 22 September 2025.

Timeline

18 July 2020

Primary endpoint
22 September 2025

22 September 2025

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	18 July 2020
Primary completion	22 September 2025
Estimated completion	22 September 2025
Sites	1 location across United States

Drugs / interventions tested

Anti-CD30/CD16A Monoclonal Antibody AFM13
Cyclophosphamide (cyclophosphamide) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
Genetically Engineered Lymphocyte Therapy — full drug profile →

Conditions studied

Recurrent Anaplastic Large Cell Lymphoma — all drugs for Recurrent Anaplastic Large Cell Lymphoma →
Recurrent B-Cell Non-Hodgkin Lymphoma — all drugs for Recurrent B-Cell Non-Hodgkin Lymphoma →
Recurrent Classic Hodgkin Lymphoma — all drugs for Recurrent Classic Hodgkin Lymphoma →
Recurrent Mycosis Fungoides — all drugs for Recurrent Mycosis Fungoides →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 15 to 75, any sex, with Recurrent Anaplastic Large Cell Lymphoma or Recurrent B-Cell Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Exploring the NK cell platform for cancer immunotherapy.
Myers JA, Miller JS. · · 2021 · cited 977× · PMID 32934330 · DOI 10.1038/s41571-020-0426-7
Natural killer cells in antitumour adoptive cell immunotherapy.
Laskowski TJ, Biederstädt A, Rezvani K. · · 2022 · cited 547× · PMID 35879429 · DOI 10.1038/s41568-022-00491-0
Harnessing natural killer cells for cancer immunotherapy: dispatching the first responders.
Maskalenko NA, Zhigarev D, Campbell KS. · · 2022 · cited 174× · PMID 35314852 · DOI 10.1038/s41573-022-00413-7
Allogeneic natural killer cell therapy.
Berrien-Elliott MM, Jacobs MT, Fehniger TA. · · 2023 · cited 153× · PMID 36416736 · DOI 10.1182/blood.2022016200
Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276
Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5
Combining AFM13, a Bispecific CD30/CD16 Antibody, with Cytokine-Activated Blood and Cord Blood-Derived NK Cells Facilitates CAR-like Responses Against CD30<sup>+</sup> Malignancies.
Kerbauy LN, Marin ND, Kaplan M, Banerjee PP, et al · · 2021 · cited 123× · PMID 33986022 · DOI 10.1158/1078-0432.ccr-21-0164
A phase 1b study of AFM13 in combination with pembrolizumab in patients with relapsed or refractory Hodgkin lymphoma.
Bartlett NL, Herrera AF, Domingo-Domenech E, Mehta A, et al · · 2020 · cited 110× · PMID 32730586 · DOI 10.1182/blood.2019004701

Verify or expand the search:

Other recruiting trials for Recurrent Anaplastic Large Cell Lymphoma

Currently open trials in the same condition.

NCT03598998 — Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas · Phase 1, PHASE2 · active not recruiting
NCT03278782 — Study of Pembrolizumab (MK-3475) in Combination With Romidepsin · Phase 1, PHASE2 · active not recruiting
NCT03017820 — A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in · Phase 1 · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04074746 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 30 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04074746.

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