NCT04206943: ISIKOK-19

Study of CD19 Specific Chimeric Antigen Receptor Positive T Cells (CAR-T) in ALL and NHL

Status unknown Phase 1, PHASE2 Last updated 27 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Car-T Cell Therapy in Acute Lymphoblastic Leukemia in 24 participants. Status unknown.

Timeline

12 October 2019

Primary endpoint
1 January 2021

1 January 2021

Quick facts

Lead sponsor	Acibadem University
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	12 October 2019
Primary completion	1 January 2021
Estimated completion	1 January 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Car-T Cell Therapy

Conditions studied

• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
• Non Hodgkin Lymphoma — all drugs for Non Hodgkin Lymphoma →

Sponsor

Acibadem University

Who can join

Adults 3 to 65, any sex, with Acute Lymphoblastic Leukemia or Non Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is a treatment that activates and strengthens the immune system against cancer. Recently, T cell receptors have been genetically rearranged by adaptive T cell therapies, which are promising in the fight against cancer, and are now able to recognize antigens on tumor cells. These modified T cell receptors are called chimeric antigen receptors. Many previous clinical studies have shown that different CAR-T cells are effective in relapse / refractory B cell cancers and NHL.

Publications & conference data

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

1. A deep insight into CRISPR/Cas9 application in CAR-T cell-based tumor immunotherapies.
   Razeghian E, Nasution MKM, Rahman HS, Gardanova ZR, et al · · 2021 · cited 80× · PMID 34321099 · DOI 10.1186/s13287-021-02510-7
2. Enhancing the safety of CAR-T cell therapy: Synthetic genetic switch for spatiotemporal control.
   Lu L, Xie M, Yang B, Zhao WB, et al · · 2024 · cited 52× · PMID 38394207 · DOI 10.1126/sciadv.adj6251
3. CRISPR, CAR-T, and NK: Current applications and future perspectives.
   Khoshandam M, Soltaninejad H, Hamidieh AA, Hosseinkhani S. · · 2024 · cited 11× · PMID 38545126 · DOI 10.1016/j.gendis.2023.101121
4. Preclinical Assessment of Efficacy and Safety Analysis of CAR-T Cells (ISIKOK-19) Targeting CD19-Expressing B-Cells for the First Turkish Academic Clinical Trial with Relapsed/Refractory ALL and NHL Patients
   Taştan C, Kançağı DD, Turan RD, Yurtsever B, et al · · 2020 · cited 10× · PMID 32755128 · DOI 10.4274/tjh.galenos.2020.2020.0070
5. Genetic Modification of T Cells for the Immunotherapy of Cancer.
   Quinn S, Lenart N, Dronzek V, Scurti GM, et al · · 2022 · cited 7× · PMID 35335089 · DOI 10.3390/vaccines10030457
6. Current Approaches to Philadelphia Chromosome-Positive B-Cell Lineage Acute Lymphoblastic Leukemia: Role of Tyrosine Kinase Inhibitor and Stem Cell Transplant.
   Kim K, Jabbour E, Short NJ, Kebriaei P, et al · · 2021 · cited 7× · PMID 34125415 · DOI 10.1007/s11912-021-01086-y
7. Preliminary Report of the Academic CAR-T (ISIKOK-19) Cell Clinical Trial in Turkey: Characterization of Product and Outcomes of Clinical Application
   Erdoğan E, Yalçın K, Hemşinlioğlu C, Sezgin A, et al · · 2022 · cited 4× · PMID 35848614 · DOI 10.4274/tjh.galenos.2022.2022.0193
8. [How I manage relapsed/refractory B-cell acute lymphoblastic leukemia patients treated with CD19 CAR- T cells throughout whole-process management].
   Wang Y. · · 2025 · PMID 41486655 · DOI 10.3760/cma.j.cn121090-20250910-00419