NCT04558931

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

Recruiting now Phase 2 Last updated 11 October 2023

What this trial tests

Phase 2 trial testing CellProtect in Multiple Myeloma in 62 participants. Currently enrolling.

Timeline

2 June 2021

Primary endpoint
31 December 2027

31 December 2032

Quick facts

Lead sponsor	Karolinska Institutet
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	2 June 2021
Primary completion	31 December 2027
Estimated completion	31 December 2032
Sites	1 location across Sweden

Drugs / interventions tested

• CellProtect — full drug profile →
• Isatuximab (isatuximab) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.

Publications & conference data

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

1. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
   Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
2. Harnessing CD16-Mediated NK Cell Functions to Enhance Therapeutic Efficacy of Tumor-Targeting mAbs.
   Capuano C, Pighi C, Battella S, De Federicis D, et al · · 2021 · cited 62× · PMID 34065399 · DOI 10.3390/cancers13102500
3. Unleashing the power of NK cells in anticancer immunotherapy.
   Vogler M, Shanmugalingam S, Särchen V, Reindl LM, et al · · 2022 · cited 16× · PMID 34374809 · DOI 10.1007/s00109-021-02120-z
4. Harnessing the Potential of NK Cell-Based Immunotherapies against Multiple Myeloma.
   Reina-Ortiz C, Giraldos D, Azaceta G, Palomera L, et al · · 2022 · cited 13× · PMID 35159200 · DOI 10.3390/cells11030392
5. Natural Killer Cells: A Promising Kit in the Adoptive Cell Therapy Toolbox.
   Xiao J, Zhang T, Gao F, Zhou Z, et al · · 2022 · cited 10× · PMID 36428748 · DOI 10.3390/cancers14225657
6. Therapeutic Potential of Innate Lymphoid Cells for Multiple Myeloma Therapy.
   Szudy-Szczyrek A, Ahern S, Kozioł M, Majowicz D, et al · · 2021 · cited 7× · PMID 34638291 · DOI 10.3390/cancers13194806
7. Balancing the CD38 Expression on Effector and Target Cells in Daratumumab-Mediated NK Cell ADCC against Multiple Myeloma.
   Lejeune M, Duray E, Peipp M, Clémenceau B, et al · · 2021 · cited 6× · PMID 34203012 · DOI 10.3390/cancers13123072
8. Natural killer cells affect the natural course, drug resistance, and prognosis of multiple myeloma.
   Zhang L, Peng X, Ma T, Liu J, et al · · 2024 · cited 5× · PMID 38410372 · DOI 10.3389/fcell.2024.1359084