NCT03019666

Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL

Completed Phase 1 Last updated 4 November 2022

What this trial tests

Phase 1 trial testing Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells in Multiple Myeloma in 39 participants. Completed in 15 August 2022.

Timeline

18 October 2017

Primary endpoint
15 August 2022

15 August 2022

Quick facts

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	18 October 2017
Primary completion	15 August 2022
Estimated completion	15 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →
• Non-Hodgkin Lymphoma — all drugs for Non-Hodgkin Lymphoma →
• Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →
• Mantle-Cell Lymphoma — all drugs for Mantle-Cell Lymphoma →

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

Adults 18 to 70, any sex, with Multiple Myeloma or Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I trial with pilot expansion of HLA-haploidentical or HLA-mismatched related donor nicotinamide expanded-natural killer (NAM-NK) cell based therapy for patients with relapsed or refractory multiple myeloma (MM) or relapsed/refractory CD20-positive non-Hodgkin lymphoma (NHL). The primary endpoint of the study is to determine the maximum tolerated dose (MTD) of NAM-NK cells while maintaining safety.

Publications & conference data

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

1. NAD⁺ metabolism: pathophysiologic mechanisms and therapeutic potential.
   Xie N, Zhang L, Gao W, Huang C, et al · · 2020 · cited 744× · PMID 33028824 · DOI 10.1038/s41392-020-00311-7
2. 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
3. Immunoprophylactic and immunotherapeutic control of hormone receptor-positive breast cancer.
   Buqué A, Bloy N, Perez-Lanzón M, Iribarren K, et al · · 2020 · cited 100× · PMID 32732875 · DOI 10.1038/s41467-020-17644-0
4. Advances in NK cell therapy for hematologic malignancies: NK source, persistence and tumor targeting.
   Merino A, Maakaron J, Bachanova V. · · 2023 · cited 49× · PMID 36959057 · DOI 10.1016/j.blre.2023.101073
5. Nicotinamide enhances natural killer cell function and yields remissions in patients with non-Hodgkin lymphoma.
   Cichocki F, Zhang B, Wu CY, Chiu E, et al · · 2023 · cited 36× · PMID 37467318 · DOI 10.1126/scitranslmed.ade3341
6. Nicotinamide (niacin) supplement increases lipid metabolism and ROS-induced energy disruption in triple-negative breast cancer: potential for drug repositioning as an anti-tumor agent.
   Jung M, Lee KM, Im Y, Seok SH, et al · · 2022 · cited 35× · PMID 35278276 · DOI 10.1002/1878-0261.13209
7. Novel Agents in Multiple Myeloma.
   Szalat R, Munshi NC. · · 2019 · cited 21× · PMID 30694859 · DOI 10.1097/ppo.0000000000000355
8. Targeting natural killer cells: from basic biology to clinical application in hematologic malignancies.
   Shang J, Hu S, Wang X. · · 2024 · cited 13× · PMID 38396050 · DOI 10.1186/s40164-024-00481-y