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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

Completed Phase 1 Last updated 18 March 2022
What this trial tests

Phase 1 trial testing pCAR-19B cells in Acute Lymphoblastic Leukemia in 9 participants. Completed in 1 September 2021.

Timeline
5 November 2019
Primary endpoint
29 June 2021
1 September 2021

Quick facts

Lead sponsorChongqing Precision Biotech Co., Ltd
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date5 November 2019
Primary completion29 June 2021
Estimated completion1 September 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  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:

Other trials of pCAR-19B cells

Trials testing the same drug.

Other recruiting trials for Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

Other Chongqing Precision Biotech Co., Ltd trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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