AML (Acute Myelogenous Leukemia), B-cell Lymphoma, Chronic Lymphocytic Leukemia, Hematologic Malignancy, Prostate Cancer
Conditions
Brief summary
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
BIOLOGICALUniCAR02-T (IMP) With Targeting Module TM123
No investigational product will be administered
BIOLOGICALUniCAR02-T-pPSMA
No investigational product will be administered
BIOLOGICALAllo-RevCAR01- T with Targeting Module R-TM123
No investigational product will be administered
BIOLOGICALAllo-QuadCAR01-T
No investigational product will be administered
Sponsors
AvenCell Therapeutics, Inc.
AvenCell Europe GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 15 years | OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause. |
| Progression-Free Survival (PFS) | 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. |
| Event-free survival (EFS) | 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. |
| Cause of death | 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. |
| RCR in peripheral blood | 15 years post last treatment | Number of participants with measurable RCR in peripheral blood |
| Pre-existing GvHD | 15 years post last treatment | Number of participants with new incidence or exacerbation of a pre-existing GvHD |
Countries
Germany
Outcome results
None listed