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NCT04888468
Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
Phase 1 trial testing pCAR-19B cells in Acute Lymphoblastic Leukemia in 9 participants. Completed in 1 September 2021.
29 June 2021
Quick facts
| Lead sponsor | Chongqing Precision Biotech Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 5 November 2019 |
| Primary completion | 29 June 2021 |
| Estimated completion | 1 September 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- pCAR-19B cells — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
- Relapsed Pediatric ALL — all drugs for Relapsed Pediatric ALL →
- Refractory Acute Lymphoblastic Leukemia — all drugs for Refractory Acute Lymphoblastic Leukemia →
Sponsor
Chongqing Precision Biotech Co., Ltd — full company profile →
Who can join
Adults 3 to 21, any sex, with Acute Lymphoblastic Leukemia or Relapsed Pediatric ALL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Infection complications in febrile chimeric antigen receptor (CAR)-T recipients during the peri-CAR-T cell treatment period examined using metagenomic next-generation sequencing (mNGS).
Nie J, Yang L, Huang L, Gao L, et al · · 2022 · cited 16× · PMID 35032364 · DOI 10.1002/cac2.12260 -
CAR-modified immune cells as a rapidly evolving approach in the context of cancer immunotherapies.
Faeq MH, Al-Haideri M, Mohammad TAM, Gharebakhshi F, et al · · 2023 · cited 7× · PMID 37083979 · DOI 10.1007/s12032-023-02019-4 -
Use of blinatumomab and CAR T-cell therapy in children with relapsed/refractory leukemia: A case series study.
Wang S, Liu A, Wang N, Wang Y, et al · · 2022 · cited 2× · PMID 36727001 · DOI 10.3389/fped.2022.1100404
Verify or expand the search:
- PubMed search for NCT04888468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of pCAR-19B cells
Trials testing the same drug.
- NCT05334823 — A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents · Phase 2 · recruiting
- NCT04888442 — Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL · Phase 1 · unknown
Other recruiting trials for Acute Lymphoblastic Leukemia
Currently open trials in the same condition.
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- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT05621291 — A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Follo · NA · recruiting
- NCT07356154 — A Study of Revumenib and Mezigdomide in People With Leukemia · Phase 1, PHASE2 · recruiting
- NCT07479927 — Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Alloge · NA · recruiting
Other Chongqing Precision Biotech Co., Ltd trials
Trials by the same sponsor.
- NCT07181720 — CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors · Phase 1 · recruiting
- NCT07179692 — CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors · Phase 1 · recruiting
- NCT07184450 — Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases · Phase 1 · recruiting
- NCT07239323 — In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies · Phase 1 · recruiting
- NCT06892145 — Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE · Phase 1 · 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 NCT04888468 (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 Chongqing Precision Biotech Co., Ltd
- Last refreshed: 18 March 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/NCT04888468.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing