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NCT04257175
CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression
Phase 2, PHASE3 trial testing CAR-T CD19 in Acute Myeloid Leukemia in 10 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Sheba Medical Center |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 18 February 2020 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- CAR-T CD19 — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
Sheba Medical Center
Who can join
18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel. However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia. The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
T cells in health and disease.
Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y -
CAR-T cell therapy for cancer: current challenges and future directions.
Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w -
Emerging Trends in Immunotherapy for Cancer.
Mishra AK, Ali A, Dutta S, Banday S, et al · · 2022 · cited 41× · PMID 36135216 · DOI 10.3390/diseases10030060 -
Immune escape mechanisms and therapeutic approaches in cancer: the cancer-immunity cycle.
Starzer AM, Preusser M, Berghoff AS. · · 2022 · cited 39× · PMID 35510032 · DOI 10.1177/17588359221096219 -
Recent Advances in Immune-Based Therapies for Acute Myeloid Leukemia.
Restelli C, Ruella M, Paruzzo L, Tarella C, et al · · 2024 · cited 36× · PMID 38904305 · DOI 10.1158/2643-3230.bcd-23-0202 -
Challenges and Advances in Chimeric Antigen Receptor Therapy for Acute Myeloid Leukemia.
Marvin-Peek J, Savani BN, Olalekan OO, Dholaria B. · · 2022 · cited 30× · PMID 35158765 · DOI 10.3390/cancers14030497 -
T-cells engineered with a novel VHH-based chimeric antigen receptor against CD19 exhibit comparable tumoricidal efficacy to their FMC63-based counterparts.
Nasiri F, Safarzadeh Kozani P, Rahbarizadeh F. · · 2023 · cited 29× · PMID 36875091 · DOI 10.3389/fimmu.2023.1063838 -
Outcomes with chimeric antigen receptor t-cell therapy in relapsed or refractory acute myeloid leukemia: a systematic review and meta-analysis.
Shahzad M, Nguyen A, Hussain A, Ammad-Ud-Din M, et al · · 2023 · cited 28× · PMID 37168849 · DOI 10.3389/fimmu.2023.1152457
Verify or expand the search:
- PubMed search for NCT04257175
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04257175 (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 Sheba Medical Center
- Last refreshed: 28 November 2023
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/NCT04257175.
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