NCT04844086

RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies

Terminated Phase 1 Last updated 18 May 2022

What this trial tests

Phase 1 trial testing RPM CD19-mbIL15-CAR-T cells in B-cell Acute Lymphoblastic Leukemia in 2 participants. Terminated before completion.

Timeline

2 March 2021

Primary endpoint
12 May 2022

12 May 2022

Quick facts

Lead sponsor	Eden BioCell Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	2 March 2021
Primary completion	12 May 2022
Estimated completion	12 May 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• RPM CD19-mbIL15-CAR-T cells — full drug profile →

Conditions studied

• B-cell Acute Lymphoblastic Leukemia — all drugs for B-cell Acute Lymphoblastic Leukemia →
• Non-Hodgkin's Lymphoma, Relapsed — all drugs for Non-Hodgkin's Lymphoma, Relapsed →
• Non-Hodgkin's Lymphoma Refractory — all drugs for Non-Hodgkin's Lymphoma Refractory →
• Primary Mediastinal Large B Cell Lymphoma — all drugs for Primary Mediastinal Large B Cell Lymphoma →

Sponsor

Eden BioCell Ltd. — full company profile →

Who can join

Adults 20 to 75, any sex, with B-cell Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma, Relapsed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label Phase 1 study to determine the feasibility, safety, and the recommended maximum tolerated Dose (MTD) of a single infusion of RPM CD19 mbIL15 CAR-T cells for adult patients. Approximately 24 subjects will be enrolled and it is anticipated approximately 16 subjects will be infused at the varied doses of T cells.

Publications & conference data

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

1. Mechanisms of resistance to chimeric antigen receptor-T cells in haematological malignancies.
   Ruella M, Korell F, Porazzi P, Maus MV. · · 2023 · cited 123× · PMID 37907724 · DOI 10.1038/s41573-023-00807-1
2. Interleukin 15 in Cell-Based Cancer Immunotherapy.
   Zhou Y, Husman T, Cen X, Tsao T, et al · · 2022 · cited 68× · PMID 35806311 · DOI 10.3390/ijms23137311
3. CAR T Cell Therapy: A Versatile Living Drug.
   De Marco RC, Monzo HJ, Ojala PM. · · 2023 · cited 62× · PMID 37047272 · DOI 10.3390/ijms24076300
4. 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
5. Advances in CAR-T therapy for central nervous system tumors.
   Zhou D, Zhu X, Xiao Y. · · 2024 · cited 15× · PMID 39506843 · DOI 10.1186/s40364-024-00679-6
6. New insights into the stemness of adoptively transferred T cells by γc family cytokines.
   Luo M, Gong W, Zhang Y, Li H, et al · · 2023 · cited 12× · PMID 38049832 · DOI 10.1186/s12964-023-01354-3
7. 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
8. Research progress on resistance mechanisms to CAR-T cell therapy in diffuse large B-cell lymphoma.
   Zhang S, Liu J, Li Z. · · 2026 · PMID 41800035 · DOI 10.3389/fonc.2026.1696105