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

N/AEnrolling By InvitationNCT07474051

AvenCell Therapeutics, Inc.178 enrolled

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.

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

178

Conditions

B-cell Lymphoma Chronic Lymphocytic Leukemia Hematologic Malignancy AML (Acute Myelogenous Leukemia)Prostate Cancer

Interventions

UniCAR02-T (IMP) With Targeting Module TM123BIOLOGICAL

No investigational product will be administered

UniCAR02-T-pPSMABIOLOGICAL

No investigational product will be administered

Allo-RevCAR01- T with Targeting Module R-TM123BIOLOGICAL

No investigational product will be administered

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (5)

Charité Universitätsmedizin Berlin

Berlin, Germany

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus

Dresden, Germany

Universitätsklinikum Marburg

Marburg, Germany

Klinikum der Universität (LMU) Muenchen

Munich, Germany

Outcomes

Primary Outcomes

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

Time frame: Up to 15 years

Secondary Outcomes

Overall Survival (OS)

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 15 years

RCR in peripheral blood

Data from ClinicalTrials.gov

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