Long-Term Follow-Up of AvenCell Sponsored CAR-T Cell Clinical Trials (PERSIST)

Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: B-cell Lymphoma; Prostate Cancer; Chronic Lymphocytic Leukemia; Hematologic Malignancy; AML (Acute Myelogenous Leukemia)
• Intervention / Treatment: Biological: UniCAR02-T (IMP) With Targeting Module TM123; Biological: UniCAR02-T-pPSMA; Biological: Allo-RevCAR01- T with Targeting Module R-TM123; Biological: Allo-QuadCAR01-T

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.

• Study Type: Observational
• Enrollment (Estimated): 178

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin
  • Dresden, Germany
    • Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
  • Marburg, Germany
    • Universitätsklinikum Marburg
  • Munich, Germany
    • Klinikum der Universität (LMU) Muenchen
  • Ulm, Germany
    • Universitatsklinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants Who Received an AvenCell CAR-T Cell Therapy

Description

Inclusion Criteria:

1. Participant who received an AVC-CAR-T cell therapy within an AVC-sponsored clinical trial.
2. Participant signed written informed consent for the AVC-PERSIST study.

Exclusion Criteria:

1. Participant is unable to provide written informed consent.
2. Participant is unable to comply with study requirements in the eyes of the Investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UniCAR02-T With Targeting Module TM123 (UC02-123-01); All participants who previously received UniCAR02-T With Targeting Module TM123 in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: UniCAR02-T (IMP) With Targeting Module TM123; No investigational product will be administered
UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01); All participants who previously received UniCAR02-T With Targeting Module TMpPSMA in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: UniCAR02-T-pPSMA; No investigational product will be administered
Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01); All participants who previously received Allo-RevCAR01- T Targeting Module R-TM123 in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: Allo-RevCAR01- T with Targeting Module R-TM123; No investigational product will be administered
Allo-QuadCAR01-T (AVC-203-01); All participants who previously received Allo-QuadCAR01-T in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: Allo-QuadCAR01-T; No investigational product will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy	Number of participants with serious adverse events (SAEs); Number of participants with new malignancies or recurrence of pre-existing malignancy; Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder; Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder; Number of participants with new incidence of serious hematologic disorder; Number of participants with new incidence of and/or recurring severe infection(s); Number of pregnancy complications and newborn health complications	Up to 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.	Up to 15 years
Progression-Free Survival (PFS)	PFS is defined as the time from Allo-QuadCAR01-T infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.	Up to 15 years
Event-free survival (EFS)	EFS is defined as the time from treatment initiation to the first occurrence of disease progression, relapse, initiation of new anti-cancer therapy, or death from any cause.	Up to 15 years
Cause of death	Cause of Death is defined as the underlying disease, treatment-related toxicity, or other medical event leading directly to a participant's death, as determined by the investigator.	Up to 15 years
RCR in peripheral blood	Number of participants with measurable RCR in peripheral blood	15 years post last treatment
Pre-existing GvHD	Number of participants with new incidence or exacerbation of a pre-existing GvHD	15 years post last treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detectable CAR transgene	Number of participants with detectable CAR transgene levels in peripheral blood by means of vector copy number (VCN)	Up to 15 years

Collaborators and Investigators

• Sponsor: AvenCell Therapeutics, Inc.
• Collaborators: AvenCell Europe GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): November 30, 2040
• Study Completion (Estimated): January 30, 2041

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Lymphoma; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Prostatic Neoplasms; Leukemia, Myeloid, Acute; Hematologic Neoplasms; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Ribonucleotides; Nucleotides; Purine Nucleotides; Inosine Nucleotides; Inosine Monophosphate
• Other Study ID Numbers: AVC-PERSIST; 2025-521717-67-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No