This exploratory study will be a proof-of-concept, open-label, single-center study to explore the feasibility of anti-CD8 PET imaging to gain insights into the biodistribution of CD8+ T-cell before and after CD19-directed CAR T-cell therapy in R/R…
ID
Bron
Verkorte titel
Aandoening
Large B-cell Lymphoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- To determine the whole-body biodistribution of the ZED88082A tracer in normal tissues and tumor lesions before and after CAR T-cell therapy.
Achtergrond van het onderzoek
This is a single-center, single-arm trial designed to evaluate the distribution of endogenous CD8+ T-cells in patients with LBCL prior to CAR T-cell therapy and after CD19-directed CAR T-cell therapy.
Doel van het onderzoek
This exploratory study will be a proof-of-concept, open-label, single-center study to explore the feasibility of anti-CD8 PET imaging to gain insights into the biodistribution of CD8+ T-cell before and after CD19-directed CAR T-cell therapy in R/R LBCL.
Onderzoeksopzet
D-35 until d-30 (screening), D-28 (apheresis) , D-27 until D-20 (radiation therapy o.i.), D-15 (tracer infusion), D-13 (PET), D-7 (PET), D0 (CarT infusion), D5 (tracer infusion), D7 (PET), D28 (PET), D30
Onderzoeksproduct en/of interventie
In this imaging trial, the purpose is to explore the feasibility of anti-CD8 PET imaging to gain insights into the biodistribution of CD8+ T-cell before and after CD19-directed CAR T-cell therapy in R/R LBCL.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Subjects with histologically confirmed LBCL and subtypes according to the WHO 2016 criteria
2. who fulfill the eligibility criteria for anti-CD19 CAR T-cell therapy according the Immune Effector Cell Working Group Tumorboard.
3. Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
4. Measurable disease, as defined by Lugano criteria.
5. Signed informed consent.
6. Age ≥18 at the time of signing informed consent.
7. Life expectancy ≥12 weeks.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
9. Ability to comply with the protocol.
10. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Signs or symptoms of active infection within 2 weeks prior to ZED88082A/CED88004S injection, unless treated to resolution.
2. Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g. blinatumomab).
3. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ZED88082A/CED88004S, or that may affect the interpretation of the results or render the patient at high risk from complications.
5. Pregnant or lactating women.
6. HIV-positive patients
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9034 |
| Ander register | METc UMCG : METc 2020/559 |