NCT04289220

Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia

Status unknown Phase 1 Last updated 13 May 2021

What this trial tests

Phase 1 trial testing Anti-CD19 CAR-T Cells Injection in B Cell Lymphoma in 10 participants. Status unknown.

Timeline

15 March 2020

Primary endpoint
15 March 2023

15 September 2023

Quick facts

Lead sponsor	Yan'an Affiliated Hospital of Kunming Medical University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	15 March 2020
Primary completion	15 March 2023
Estimated completion	15 September 2023
Sites	1 location across China

Drugs / interventions tested

• Anti-CD19 CAR-T Cells Injection — full drug profile →

Conditions studied

• B Cell Lymphoma — all drugs for B Cell Lymphoma →
• B-cell Acute Lymphoblastic Leukemia — all drugs for B-cell Acute Lymphoblastic Leukemia →

Sponsor

Yan'an Affiliated Hospital of Kunming Medical University

Who can join

Adults 18 to 70, any sex, with B Cell Lymphoma or B-cell Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Our previous study demonstrated that anti-CD19 chimeric antigen receptor in piggyBac transposon-engineered T cells have strong tumor-killing activity in vitro and therapeutic effects in cell line-derived xenograft models, and no obvious side effects such as neurotoxicity and cytokine storm occurred. Therefore, we want to evaluate the safety and clinical effect of anti-CD19 CAR-T cells in clinical trials.

Publications & conference data

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

1. The Past, Present, and Future of Non-Viral CAR T Cells.
   Moretti A, Ponzo M, Nicolette CA, Tcherepanova IY, et al · · 2022 · cited 103× · PMID 35757746 · DOI 10.3389/fimmu.2022.867013
2. Choosing the Right Tool for Genetic Engineering: Clinical Lessons from Chimeric Antigen Receptor-T Cells.
   Irving M, Lanitis E, Migliorini D, Ivics Z, et al · · 2021 · cited 86× · PMID 34662233 · DOI 10.1089/hum.2021.173
3. Contemporary Transposon Tools: A Review and Guide through Mechanisms and Applications of <i>Sleeping Beauty</i>, <i>piggyBac</i> and <i>Tol2</i> for Genome Engineering.
   Sandoval-Villegas N, Nurieva W, Amberger M, Ivics Z. · · 2021 · cited 84× · PMID 34064900 · DOI 10.3390/ijms22105084
4. Role of Transposable Elements in Genome Stability: Implications for Health and Disease.
   Bhat A, Ghatage T, Bhan S, Lahane GP, et al · · 2022 · cited 63× · PMID 35887150 · DOI 10.3390/ijms23147802
5. Universal allogeneic CAR T cells engineered with Sleeping Beauty transposons and CRISPR-CAS9 for cancer immunotherapy.
   Tipanee J, Samara-Kuko E, Gevaert T, Chuah MK, et al · · 2022 · cited 60× · PMID 35711141 · DOI 10.1016/j.ymthe.2022.06.006
6. Transposon-Based CAR T Cells in Acute Leukemias: Where are We Going?
   Magnani CF, Tettamanti S, Alberti G, Pisani I, et al · · 2020 · cited 40× · PMID 32471151 · DOI 10.3390/cells9061337
7. CAR T-Cell Production Using Nonviral Approaches.
   Lukjanov V, Koutná I, Šimara P. · · 2021 · cited 39× · PMID 33855089 · DOI 10.1155/2021/6644685
8. Cas9-induced targeted integration of large DNA payloads in primary human T cells via homology-mediated end-joining DNA repair.
   Webber BR, Johnson MJ, Skeate JG, Slipek NJ, et al · · 2024 · cited 24× · PMID 38092857 · DOI 10.1038/s41551-023-01157-4