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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521717-67-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| AvenCell Europe GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UniCAR02-T (IMP) With Targeting Module TM123 | Biological | No investigational product will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy |
| Up to 15 years |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Participants Who Received an AvenCell CAR-T Cell Therapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Berlin | Germany | ||||
| Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus |
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| UniCAR02-T-pPSMA | Biological | No investigational product will be administered |
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| Allo-RevCAR01- T with Targeting Module R-TM123 | Biological | No investigational product will be administered |
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| Allo-QuadCAR01-T | Biological | No investigational product will be administered |
|
| 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 |
| Dresden |
| Germany |
| Universitätsklinikum Marburg | Marburg | Germany |
| Klinikum der Universität (LMU) Muenchen | Munich | Germany |
| Universitatsklinikum Ulm | Ulm | Germany |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D007951 | Leukemia, Myeloid |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D007291 | Inosine Monophosphate |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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