Long-Term Follow-Up of AvenCell Sponsored CAR-T Cell Clinical Trials
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UniCAR02-T (IMP) With Targeting Module TM123, UniCAR02-T-pPSMA, Allo-RevCAR01- T with Targeting Module R-TM123, Allo-QuadCAR01-T.
- Who it may be relevant to
- Registry conditions: B-cell Lymphoma, Chronic Lymphocytic Leukemia, Hematologic Malignancy, AML (Acute Myelogenous Leukemia). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy
Overview
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms.
Detailed description
To assess the incidence and severity of delayed serious adverse events (SAEs) possibly related to AVC-CAR-T cell therapy and AEs of special interest (AESIs), including secondary malignancies, neurologic disorders, rheumatologic or other autoimmune disorders, newly diagnosed serious hematologic disorders, severe infections, as well as pregnancy and newborn health complications where observed.
Interventions
- Biological UniCAR02-T (IMP) With Targeting Module TM123
No investigational product will be administered - Biological UniCAR02-T-pPSMA
No investigational product will be administered - Biological Allo-RevCAR01- T with Targeting Module R-TM123
No investigational product will be administered - Biological Allo-QuadCAR01-T
No investigational product will be administered
Primary outcome measures
- To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy [Time frame: Up to 15 years]
Secondary outcome measures (6)
- Overall Survival (OS) [Time frame: Up to 15 years]
- Progression-Free Survival (PFS) [Time frame: Up to 15 years]
- Event-free survival (EFS) [Time frame: Up to 15 years]
- Cause of death [Time frame: Up to 15 years]
- RCR in peripheral blood [Time frame: 15 years post last treatment]
- Pre-existing GvHD [Time frame: 15 years post last treatment]
Eligibility criteria
Inclusion criteria
- Participant who received an AVC-CAR-T cell therapy within an AVC-sponsored clinical trial.
- Participant signed written informed consent for the AVC-PERSIST study.
Exclusion criteria
- Participant is unable to provide written informed consent.
- Participant is unable to comply with study requirements in the eyes of the Investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 5 centers
- Charité Universitätsmedizin Berlin — Berlin
- Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus — Dresden
- Universitätsklinikum Marburg — Marburg
- Klinikum der Universität (LMU) Muenchen — Munich
- Universitatsklinikum Ulm — Ulm
Identifiers
NCT: NCT07474051 · AVC-PERSIST · 2025-521717-67-00