NCT04260945

CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients

Completed Phase 1 Last updated 8 March 2022

What this trial tests

Phase 1 trial testing CD19/CD20 Dual-CAR-T cells in B-cell Leukemia in 12 participants. Completed in 10 February 2022.

Timeline

10 March 2020

Primary endpoint
10 October 2021

10 February 2022

Quick facts

Lead sponsor	Hebei Yanda Ludaopei Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	10 March 2020
Primary completion	10 October 2021
Estimated completion	10 February 2022
Sites	1 location across China

Drugs / interventions tested

• CD19/CD20 Dual-CAR-T cells — full drug profile →

Conditions studied

• B-cell Leukemia — all drugs for B-cell Leukemia →

Sponsor

Hebei Yanda Ludaopei Hospital

Who can join

Adults 1 to 70, any sex, with B-cell Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell leukemia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune Dysfunctions and Immune-Based Therapeutic Interventions in Chronic Lymphocytic Leukemia.
   Griggio V, Perutelli F, Salvetti C, Boccellato E, et al · · 2020 · cited 54× · PMID 33312177 · DOI 10.3389/fimmu.2020.594556
2. 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
3. Learning from TCR Signaling and Immunological Synapse Assembly to Build New Chimeric Antigen Receptors (CARs).
   Cassioli C, Patrussi L, Valitutti S, Baldari CT. · · 2022 · cited 17× · PMID 36430728 · DOI 10.3390/ijms232214255
4. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
5. 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
6. Breakthroughs in Cancer Immunotherapy: An Overview of T Cell, NK Cell, Mφ, and DC-Based Treatments.
   Lee S, Kim TD. · · 2023 · cited 10× · PMID 38139461 · DOI 10.3390/ijms242417634
7. Multi-targeted immunotherapeutics to treat B cell malignancies.
   Gambles MT, Yang J, Kopeček J. · · 2023 · cited 8× · PMID 37121515 · DOI 10.1016/j.jconrel.2023.04.048
8. 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