CD8 PET imaging study before and after CAR T-cell therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

22 May 2026 → 22 May 2026

Decision date (initial)

2025-01-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520560-18-00

EudraCT number

2020-004749-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis

The objective is to study the distribution of CD8+ T-cells before and after CAR T-cell
therapy in the patient by ZED88082A/CED88004S-PET imaging. We will correlate the
pretreatment CD8+ T-cell distribution and CD8+ CAR T-cell tumor invasion, as
measured by the intensity of ZED88082A/CED88004S-PET imaging positive lesions.

Secondary objectives 5

1. Assess safety and dosimetry ZED88082A/CED88004S uptake in the setting of CD19- directed CAR T-cell therapy
2. To assess heterogeneity of ZED88082A/CED88004S tumor uptake
3. To correlate normal organ ZED88082A/CED88004S uptake to (serious) adverse events (possibly) related to CAR T-cell treatment
4. To correlate tumor ZED88082A/CED88004S uptake with tumor and immune cell CD8-expression as assessed by a fresh contemporaneous tumor biopsy
5. To correlate ZED88082A/CED88004S uptake in irradiated versus non-irradiated lymphoma lesions in patients who require radiotherapy as bridging strategy prior to CAR T-cell infusion

Conditions and MedDRA coding

Large B-cell lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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]

Exclusion criteria 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To determine the whole-body biodistribution of the ZED88082A tracer in normal tissues and tumor lesions before and after CAR T-cell therapy. Heterogeneity of ZED88082A/CED88004S uptake evaluated by measuring standardized uptake value (SUV) on the ZED88082A/CED88004S-PET scan 2 days after ZED88082A/CED88004S injection.

Secondary endpoints 5

1. Assess safety and dosimetry ZED88082A/CED88004S uptake in the setting of CD19- directed CAR T-cell therapy
2. Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, CD8 expression in tumor biopsy, and response to CAR T-cell therapy
3. To perform correlative expression analysis between SUV parameters of ZED88082A tracer in the tumor, CD8 expression in tumor biopsy, and SUV parametersin the tumor and whole-body and CAR T-cell persistence, peak level and CAR T-cell phenotype as measured in the peripheral blood.
4. Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, and grade 1-5 adverse events to CAR T-cell therapy, including cytokine release syndrome and neurotoxicity.
5. to correlate ZED88082A/CED88004S uptake in lymphoma to radiated to non-radiated areas infield and outfield of radiation therapy in patients receiving radiation therapy that require bridging to CAR T-cell infusion

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Tom van Meerten

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Tom van Meerten

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications