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NCT04796675
Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for B Lymphoid Malignancies
Phase 1 trial testing Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells in Acute Lymphocytic Leukemia in 27 participants. Status unknown.
10 March 2023
Quick facts
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 10 April 2021 |
| Primary completion | 10 March 2023 |
| Estimated completion | 10 March 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells — full drug profile →
Conditions studied
- Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
- Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
- Non Hodgkin's Lymphoma — all drugs for Non Hodgkin's Lymphoma →
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Who can join
18 and older, any sex, with Acute Lymphocytic Leukemia or Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD19 chimeric antigen receptor(CAR)-modified NK cells(CAR-NK-CD19) in patients with relapsed or refractory hematological malignancies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Natural killer cells in antitumour adoptive cell immunotherapy.
Laskowski TJ, Biederstädt A, Rezvani K. · · 2022 · cited 547× · PMID 35879429 · DOI 10.1038/s41568-022-00491-0 -
Exploring treatment options in cancer: Tumor treatment strategies.
Liu B, Zhou H, Tan L, Siu KTH, et al · · 2024 · cited 536× · PMID 39013849 · DOI 10.1038/s41392-024-01856-7 -
CAR race to cancer immunotherapy: from CAR T, CAR NK to CAR macrophage therapy.
Pan K, Farrukh H, Chittepu VCSR, Xu H, et al · · 2022 · cited 478× · PMID 35361234 · DOI 10.1186/s13046-022-02327-z -
CAR-T: What Is Next?
Chen YJ, Abila B, Mostafa Kamel Y. · · 2023 · cited 160× · PMID 36765623 · DOI 10.3390/cancers15030663 -
Allogeneic natural killer cell therapy.
Berrien-Elliott MM, Jacobs MT, Fehniger TA. · · 2023 · cited 153× · PMID 36416736 · DOI 10.1182/blood.2022016200 -
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 -
CAR-NK cells for cancer immunotherapy: from bench to bedside.
Zhang L, Meng Y, Feng X, Han Z. · · 2022 · cited 144× · PMID 35303962 · DOI 10.1186/s40364-022-00364-6 -
Natural killer cells: a promising immunotherapy for cancer.
Chu J, Gao F, Yan M, Zhao S, et al · · 2022 · cited 140× · PMID 35606854 · DOI 10.1186/s12967-022-03437-0
Verify or expand the search:
- PubMed search for NCT04796675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells
Trials testing the same drug.
- NCT04796688 — Universal Chimeric Antigen Receptor-modified AT19 Cells for CD19+ Relapsed/Refractory Hematological Malignancies · Phase 1 · unknown
Other recruiting trials for Acute Lymphocytic Leukemia
Currently open trials in the same condition.
- NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
- NCT07008885 — BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL · Phase 1, PHASE2 · recruiting
- NCT06481735 — TCR Reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-ALL · Phase 1, PHASE2 · recruiting
- NCT06476665 — A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia. · active not recruiting
- NCT06783816 — A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors · NA · recruiting
Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials
Trials by the same sponsor.
- NCT07521124 — ABC Maintenance Therapy for AML · NA · not yet recruiting
- NCT07497243 — X-ray Assisted Diagnostic System · not yet recruiting
- NCT07520123 — Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatiti · NA · not yet recruiting
- NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
- NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · Phase 2 · not yet recruiting
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 NCT04796675 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Last refreshed: 8 April 2021
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/NCT04796675.
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