NCT06631040

Cell Therapy with Anti-CD19 CAR-NK Cells in Patients with Relapsed or Resistant B-ALL

Not yet recruiting Phase 1, PHASE2 Last updated 8 October 2024

What this trial tests

Phase 1, PHASE2 trial testing anti CD19 CAR NK cells in Acute Lymphocytic Leukemia in Relapse in 10 participants. Not yet recruiting.

Timeline

19 December 2024

Primary endpoint
20 November 2026

30 December 2026

Quick facts

Lead sponsor	Shahid Beheshti University of Medical Sciences
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	19 December 2024
Primary completion	20 November 2026
Estimated completion	30 December 2026
Sites	1 location across Iran

Drugs / interventions tested

• anti CD19 CAR NK cells — full drug profile →

Conditions studied

• Acute Lymphocytic Leukemia in Relapse — all drugs for Acute Lymphocytic Leukemia in Relapse →

Sponsor

Shahid Beheshti University of Medical Sciences

Who can join

3 and older, any sex, with Acute Lymphocytic Leukemia in Relapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immunotherapy has shown promise in treating hematological malignancies, including resistant B-ALL. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain regarding antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including CD19, with CAR-NK cells in resistant B-ALL. To further investigate the potential of anti-CD19 CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard treatment.

Publications & conference data

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

1. 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
2. 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
3. CAR-NK cells: harnessing the power of natural killers for advanced cancer therapy.
   Dos Reis FD, Saidani Y, Martín-Rubio P, Sanz-Pamplona R, et al · · 2025 · cited 11× · PMID 40519903 · DOI 10.3389/fimmu.2025.1603757
4. Natural killer cells in adoptive cell therapy: current landscape of genetic engineering strategies.
   Burón M, Etxebarria A, Álvarez M, Romayor I, et al · · 2025 · cited 4× · PMID 40996824 · DOI 10.1080/2162402x.2025.2563099
5. Expanding the frontier of CAR therapy: comparative insights into CAR-T, CAR-NK, CAR-M, and CAR-DC approaches.
   Zhang Y, Hu R, Xie X, Li Y. · · 2025 · cited 4× · PMID 40928667 · DOI 10.1007/s00277-025-06538-0
6. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
   Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
7. Strategies for the Development of NK Cell-Based Therapies for Cancer Treatment.
   Budagova T, Efremova A, Maiak M, Goldshtein D. · · 2025 · cited 1× · PMID 41369346 · DOI 10.3390/cells14231858
8. Advances in chimeric antigen receptor-natural killer cell therapy: from mechanisms and preclinical studies to clinical application.
   Ren T, Wang F, Liu X, Guo J, et al · · 2025 · PMID 41635402 · DOI 10.3389/fonc.2025.1759796