NCT06045091

To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL

Recruiting now EARLY_PHASE1 Last updated 21 September 2023

What this trial tests

EARLY_PHASE1 trial testing Human BCMA targeted CAR-NK cells injection in Multiple Myeloma in 18 participants. Currently enrolling.

Timeline

4 July 2023

Primary endpoint
30 September 2025

30 September 2027

Quick facts

Lead sponsor	Hrain Biotechnology Co., Ltd.
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	4 July 2023
Primary completion	30 September 2025
Estimated completion	30 September 2027
Sites	1 location across China

Drugs / interventions tested

• Human BCMA targeted CAR-NK cells injection — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →
• Plasma Cell Leukemia — all drugs for Plasma Cell Leukemia →

Sponsor

Hrain Biotechnology Co., Ltd. — full company profile →

Who can join

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

Sponsor's own description

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.

Publications & conference data

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

1. Development of NK cell-based cancer immunotherapies through receptor engineering.
   Page A, Chuvin N, Valladeau-Guilemond J, Depil S. · · 2024 · cited 123× · PMID 38443448 · DOI 10.1038/s41423-024-01145-x
2. Comprehensive snapshots of natural killer cells functions, signaling, molecular mechanisms and clinical utilization.
   Chen S, Zhu H, Jounaidi Y. · · 2024 · cited 106× · PMID 39511139 · DOI 10.1038/s41392-024-02005-w
3. The clinical landscape of CAR NK cells.
   Jørgensen LV, Christensen EB, Barnkob MB, Barington T. · · 2025 · cited 61× · PMID 40149002 · DOI 10.1186/s40164-025-00633-8
4. CAR-T cell therapy in Multiple Myeloma: current status and future challenges.
   Swan D, Madduri D, Hocking J. · · 2024 · cited 32× · PMID 39592597 · DOI 10.1038/s41408-024-01191-8
5. Innate immune cells in tumor microenvironment: A new frontier in cancer immunotherapy.
   Li C, Yu X, Han X, Lian C, et al · · 2024 · cited 31× · PMID 39280627 · DOI 10.1016/j.isci.2024.110750
6. The development and application of chimeric antigen receptor natural killer (CAR-NK) cells for cancer therapy: current state, challenges and emerging therapeutic advances.
   Yao P, Liu YG, Huang G, Hao L, et al · · 2024 · cited 19× · PMID 39633491 · DOI 10.1186/s40164-024-00583-7
7. Natural killer cell-based cancer immunotherapy: from basics to clinical trials.
   Shi Y, Hao D, Qian H, Tao Z. · · 2024 · cited 17× · PMID 39415291 · DOI 10.1186/s40164-024-00561-z
8. The basic biology of NK cells and its application in tumor immunotherapy.
   Jiang P, Jing S, Sheng G, Jia F. · · 2024 · cited 17× · PMID 39221244 · DOI 10.3389/fimmu.2024.1420205