Evidence map›Paper›PMID 35848614›Full record

Trial reportTurkish journal of haematology : official journal of Turkish Society of Haematology2022

Preliminary Report of the Academic CAR-T (ISIKOK-19) Cell Clinical Trial in Turkey: Characterization of Product and Outcomes of Clinical Application

Ebru Erdoğan, Koray Yalçın, Cansu Hemşinlioğlu, Aslıhan Sezgin, Utku Seyis, Derya Dilek Kançağı, Cihan Taştan, Bulut Yurtsever, Raife Dilek Turan, Didem Çakırsoy and 14 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Turkish journal of haematology : official journal of Turkish Society of Haematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04206943 (Phase I/ II Study of Cluster of Differentiation 19), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04206943 phase1 / phase2unknown statusnot on this map

Phase I/ II Study of Cluster of Differentiation 19 (CD19) Specific CAR-T Cells (ISIKOK 19) in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Non Hodgkin Lymphoma (NHL)

TypeinterventionalSponsorAcibadem UniversityRan2019 to 2021Enrolled24ConditionsAcute Lymphoblastic Leukemia, Non Hodgkin LymphomaArmsCar-T Cell Therapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Health-related quality of life dynamics: modeling insights from immunotherapy.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Ebru ErdoğanAcıbadem Altunizade Hospital, Hematology Unit, İstanbul, TurkeyORCID 0000-0002-9246-5643
Koray YalçınAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0003-3454-9870
Cansu HemşinlioğluAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0003-1165-3798
Aslıhan SezginAcıbadem Altunizade Hospital, Hematology Unit, İstanbul, Turkey
Utku SeyisAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0002-2748-0580
Derya Dilek KançağıAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0003-4725-3200
Cihan TaştanAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0002-4173-6634
Bulut YurtseverAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0002-9269-8383
Raife Dilek TuranAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0001-5159-4775
Didem ÇakırsoyAcıbadem Labcell Cellular Therapy Center, İstanbul, Turkey
Selen AbanuzAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0002-6136-5033
Gözde Sır KarakuşAcıbadem Labcell Cellular Therapy Center, İstanbul, Turkey
Muhammer ElekAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0002-3048-0557
Hüseyin Saffet BekozMedipol University Faculty of Medicine, Hematology Unit, İstanbul, Turkey
Ali İhsan GemiciMedipol University Faculty of Medicine, Hematology Unit, İstanbul, TurkeyORCID 0000-0002-3385-8359
Deniz SargınMedipol University Faculty of Medicine, Hematology Unit, İstanbul, Turkey
Mutlu Aratİstanbul Florence Nightingale Hospital, Hematology Unit, İstanbul, TurkeyORCID 0000-0003-2039-8557
Burhan FerhanoğluVKV American Hospital, Hematology Unit, İstanbul, TurkeyORCID 0000-0002-4257-549X
Ebru PekgüçVKV American Hospital, Hematology Unit, İstanbul, Turkey
Serdar ÖrnekVKV American Hospital, Hematology Unit, İstanbul, TurkeyORCID 0000-0003-2602-1742
Deram BüyüktaşVKV American Hospital, Hematology Unit, İstanbul, TurkeyORCID 0000-0002-3623-2925
Nur BirgenAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0001-7117-3396
Siret RatipAcıbadem Altunizade Hospital, Hematology Unit, İstanbul, TurkeyORCID 0000-0002-4027-5469
Ercüment OvalıAcıbadem Labcell Cellular Therapy Center, İstanbul, TurkeyORCID 0000-0002-4782-5355

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Chimeric antigen receptor T (CAR-T) cell therapies have already made an impact on the treatment of B-cell malignancies. Although CAR-T cell therapies are promising, there are concerns about commercial products regarding their affordability and sustainability. In this preliminary study, the results of the first production and clinical data of an academic CAR-T cell (ISIKOK-19) trial in Turkey are presented. Materials and Methods: A pilot clinical trial (NCT04206943) designed to assess the safety and feasibility of ISIKOK-19 T-cell therapy for patients with relapsed and refractory CD19+ tumors was conducted and participating patients received ISIKOK-19 infusions between October 2019 and July 2021. The production data of the first 8 patients and the clinical outcome of 7 patients who received ISIKOK-19 cell infusions are presented in this study. Results: Nine patients were enrolled in the trial [5 with acute lymphoblastic leukemia (ALL) and 4 with non-Hodgkin lymphoma (NHL)], but only 7 patients could receive treatment. Two of the 3 participating ALL patients and 3 of the 4 NHL patients had complete/partial response (overall response rate: 72%). Four patients (57%) had CAR-T-related toxicities (cytokine release syndrome, CAR-T-related encephalopathy syndrome, and pancytopenia). Two patients were unresponsive and had progressive disease following CAR-T therapy. Two patients with partial response had progressive disease during follow-up. Conclusion: Production efficacy and fulfillment of the criteria of quality control were satisfactory for academic production. Response rates and toxicity profiles were also acceptable for this heavily pretreated/refractory patient group. ISIKOK-19 cells appear to be a safe, economical, and efficient treatment option for CD19+ tumors. However, the findings of this study need to be supported by the currently ongoing ISIKOK-19 clinical trial.

Indexed as

Lymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaReceptors, Chimeric AntigenAntigens, CD19HumansImmunotherapy, AdoptiveReceptors, Antigen, T-CellTurkeyAntigens, CD19Receptors, Antigen, T-CellReceptors, Chimeric AntigenAcute lymphoblastic leukemiaChimeric antigen receptor T(CAR-T) cellGene therapyNon-Hodgkin lymphoma

Identifiers

PMID35848614
PMCPMC9421334

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.