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NCT03919526
Anti-CD19/CD22 Bispecific Chimeric Antigen Receptor(CAR)-T Cell Therapy for Measurable Residual Disease(MRD) Positive ALL
Phase 1 trial testing anti-CD19/CD22 CAR-T cells in MRD-positive in 19 participants. Completed in 1 November 2023.
1 November 2023
Quick facts
| Lead sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 11 August 2019 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 November 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- anti-CD19/CD22 CAR-T cells — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- MRD-positive — all drugs for MRD-positive →
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 70, any sex, with MRD-positive or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449 -
CAR-T cell combination therapy: the next revolution in cancer treatment.
Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6 -
B7-H3-Targeted CAR-T Cells Exhibit Potent Antitumor Effects on Hematologic and Solid Tumors.
Zhang Z, Jiang C, Liu Z, Yang M, et al · · 2020 · cited 105× · PMID 32346608 · DOI 10.1016/j.omto.2020.03.019 -
Bioactivity and safety of B7-H3-targeted chimeric antigen receptor T cells against anaplastic meningioma.
Tang X, Liu F, Liu Z, Cao Y, et al · · 2020 · cited 62× · PMID 32547742 · DOI 10.1002/cti2.1137 -
Enhancing the safety of CAR-T cell therapy: Synthetic genetic switch for spatiotemporal control.
Lu L, Xie M, Yang B, Zhao WB, et al · · 2024 · cited 52× · PMID 38394207 · DOI 10.1126/sciadv.adj6251 -
Advances in CAR-T Cell Genetic Engineering Strategies to Overcome Hurdles in Solid Tumors Treatment.
Andrea AE, Chiron A, Mallah S, Bessoles S, et al · · 2022 · cited 48× · PMID 35211124 · DOI 10.3389/fimmu.2022.830292 -
Targeting CD22 for the Treatment of B-Cell Malignancies.
Shah NN, Sokol L. · · 2021 · cited 42× · PMID 34262884 · DOI 10.2147/itt.s288546 -
Next-generation chimeric antigen receptors for T- and natural killer-cell therapies against cancer.
Li Y, Rezvani K, Rafei H. · · 2023 · cited 29× · PMID 37548050 · DOI 10.1111/imr.13255
Verify or expand the search:
- PubMed search for NCT03919526
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for MRD-positive
Currently open trials in the same condition.
- NCT07441291 — CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT · Phase 3 · recruiting
- NCT05940961 — Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL · Phase 2 · recruiting
Other Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
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- NCT07439120 — Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors · EARLY_PHASE1 · 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 NCT03919526 (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 General Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 8 December 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/NCT03919526.
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