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NCT05563545
Anti-CD19 CAR-Engineered NK Cells in the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia
Phase 1 trial testing CAR-NK-CD19 Cells in Acute Lymphoblastic Leukemia in 2 participants. Completed in 25 November 2022.
25 November 2022
Quick facts
| Lead sponsor | Shanghai Simnova Biotechnology Co.,Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 21 July 2022 |
| Primary completion | 25 November 2022 |
| Estimated completion | 25 November 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- CAR-NK-CD19 Cells — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Sponsor
Shanghai Simnova Biotechnology Co.,Ltd. — full company profile →
Who can join
3 and older, any sex, with Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single arm clinical study to observe the safety ，dose tolerance and pharmacokinetic characteristics of CAR NK-CD19 in patients with recurrent or refractory CD19 positive acute lymphoblastic leukemia, and preliminarily evaluate the effectiveness, the immunogenicity of the product and the correlation between the changes of cytokines after infusion and CRS , ICANS.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
CAR-T: What Is Next?
Chen YJ, Abila B, Mostafa Kamel Y. · · 2023 · cited 160× · PMID 36765623 · DOI 10.3390/cancers15030663 -
Exploiting innate immunity for cancer immunotherapy.
Yi M, Li T, Niu M, Mei Q, et al · · 2023 · cited 151× · PMID 38008741 · DOI 10.1186/s12943-023-01885-w -
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 -
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 -
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 -
Trial watch: chemotherapy-induced immunogenic cell death in oncology.
Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591 -
Chimeric antigen receptor-based natural killer cell immunotherapy in cancer: from bench to bedside.
Zhang B, Yang M, Zhang W, Liu N, et al · · 2024 · cited 50× · PMID 38221520 · DOI 10.1038/s41419-024-06438-7 -
CAR-NK as a Rapidly Developed and Efficient Immunotherapeutic Strategy against Cancer.
Włodarczyk M, Pyrzynska B. · · 2022 · cited 35× · PMID 36612114 · DOI 10.3390/cancers15010117
Verify or expand the search:
- PubMed search for NCT05563545
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Simnova Biotechnology Co.,Ltd. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05563545 (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 Shanghai Simnova Biotechnology Co.,Ltd.
- Last refreshed: 28 November 2022
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/NCT05563545.
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