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NCT03825731
A Study of GC022 CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
EARLY_PHASE1 trial testing GC022 in B-cell Acute Lymphoblastic Leukemia in 20 participants. Status unknown.
16 September 2019
Quick facts
| Lead sponsor | Hebei Yanda Ludaopei Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 17 January 2019 |
| Primary completion | 16 September 2019 |
| Estimated completion | 16 September 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- GC022 — full drug profile →
Conditions studied
- B-cell Acute Lymphoblastic Leukemia — all drugs for B-cell Acute Lymphoblastic Leukemia →
Sponsor
Hebei Yanda Ludaopei Hospital
Who can join
Adults 2 to 70, any sex, with B-cell Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of GC022 CAR-T cell immunotherapy in relapsed or refractory B-ALL. The investigators plan to include 20 subjects to receive GC022 therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Use of CAR T-cell for acute lymphoblastic leukemia (ALL) treatment: a review study.
Sheykhhasan M, Manoochehri H, Dama P. · · 2022 · cited 98× · PMID 34987176 · DOI 10.1038/s41417-021-00418-1 -
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 -
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 -
A systematic review and meta-analysis of CD22 CAR T-cells alone or in combination with CD19 CAR T-cells.
Fergusson NJ, Adeel K, Kekre N, Atkins H, et al · · 2023 · cited 23× · PMID 37180149 · DOI 10.3389/fimmu.2023.1178403 -
The future of cellular immunotherapy for childhood leukemia.
Bonifant CL, Tasian SK. · · 2020 · cited 15× · PMID 31851053 · DOI 10.1097/mop.0000000000000866 -
Analysis benefits of a second Allo-HSCT after CAR-T cell therapy in patients with relapsed/refractory B-cell acute lymphoblastic leukemia who relapsed after transplant.
Cao XY, Zhang JP, Zhao YL, Xiong M, et al · · 2023 · cited 11× · PMID 37469510 · DOI 10.3389/fimmu.2023.1191382 -
The Evolution of Chimeric Antigen Receptor T-Cell Therapy in Children, Adolescents and Young Adults with Acute Lymphoblastic Leukemia.
Ragoonanan D, Sheikh IN, Gupta S, Khazal SJ, et al · · 2022 · cited 6× · PMID 36140387 · DOI 10.3390/biomedicines10092286 -
CAR T-Cells in Acute Lymphoblastic Leukemia: Current Status and Future Prospects.
Almaeen AH, Abouelkheir M. · · 2023 · cited 5× · PMID 37893067 · DOI 10.3390/biomedicines11102693
Verify or expand the search:
- PubMed search for NCT03825731
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for B-cell Acute Lymphoblastic Leukemia
Currently open trials in the same condition.
- NCT06326008 — Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-deri · Phase 1 · recruiting
- NCT07153796 — A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemoth · Phase 2 · recruiting
- NCT06863259 — Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL · Phase 1 · recruiting
- NCT06793241 — Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia · EARLY_PHASE1 · recruiting
- NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
Other Hebei Yanda Ludaopei Hospital trials
Trials by the same sponsor.
- NCT05590091 — Study on Intelligent Nutrition Support Therapy for Hematopoietic Stem Cell Transplantation Recipients · NA · unknown
- NCT05518357 — LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia · Phase 1 · completed
- NCT04508842 — CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL) · Phase 1 · terminated
- NCT04260945 — CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients · Phase 1 · completed
- NCT04260932 — CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients · Phase 1 · completed
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 NCT03825731 (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 Hebei Yanda Ludaopei Hospital
- Last refreshed: 31 January 2019
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/NCT03825731.
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