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Enrolling by Invitation

NCT Number: NCT07474051

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

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.

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Key information

Conditions

B-cell Lymphoma AML (Acute Myelogenous Leukemia) Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Universitätsmedizin Berlin, Berlin, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UniCAR02-T (IMP) With Targeting Module TM123

Biological

No investigational product will be administered

UniCAR02-T-pPSMA

Biological

No investigational product will be administered

Allo-RevCAR01- T with Targeting Module R-TM123

Biological

No investigational product will be administered

Allo-QuadCAR01-T

Biological

No investigational product will be administered

Primary outcomes

  1. 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

    • 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

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 15 years

    OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.

  2. Progression-Free Survival (PFS)

    Time frame: Up to 15 years

    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.

  3. Event-free survival (EFS)

    Time frame: Up to 15 years

    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.

  4. Cause of death

    Time frame: Up to 15 years

    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.

  5. RCR in peripheral blood

    Time frame: 15 years post last treatment

    Number of participants with measurable RCR in peripheral blood

  6. Pre-existing GvHD

    Time frame: 15 years post last treatment

    Number of participants with new incidence or exacerbation of a pre-existing GvHD

Other outcomes

  1. Detectable CAR transgene

    Time frame: Up to 15 years

    Number of participants with detectable CAR transgene levels in peripheral blood by means of vector copy number (VCN)

Sponsors and collaborators

Lead sponsor

AvenCell Therapeutics, Inc.

Industry

Collaborators

  • AvenCell Europe GmbH

Registry information

Official study title

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

Acronym: PERSIST

Important dates

Study start
2026
Primary completion
2040
Study completion
2041
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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