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

NCT07474051 | Enrolling By Invitation

• 2 other identifiers: AVC-PERSIST2025-521717-67-00
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival (OS)

  Up to 15 years

• Progression-Free Survival (PFS)

  Up to 15 years

• Event-free survival (EFS)

  Up to 15 years

• Cause of death

  Up to 15 years

• RCR in peripheral blood

  15 years post last treatment

Other Outcomes (1)

• Detectable CAR transgene

  Up to 15 years

Study Arms (4)

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

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

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

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

Interventions

UniCAR02-T (IMP) With Targeting Module TM123 BIOLOGICAL

No investigational product will be administered

UniCAR02-T With Targeting Module TM123 (UC02-123-01)

UniCAR02-T-pPSMA BIOLOGICAL

No investigational product will be administered

UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01)

Allo-RevCAR01- T with Targeting Module R-TM123 BIOLOGICAL

No investigational product will be administered

Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01)

Allo-QuadCAR01-T BIOLOGICAL

No investigational product will be administered

Allo-QuadCAR01-T (AVC-203-01)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants Who Received an AvenCell CAR-T Cell Therapy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AvenCell Therapeutics, Inc.: lead
• AvenCell Europe GmbH: collaborator

Study Sites (5)

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus

Dresden, Germany

Location

Universitätsklinikum Marburg

Marburg, Germany

Location

Klinikum der Universität (LMU) Muenchen

Munich, Germany

Location

Universitatsklinikum Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Prostatic Neoplasms

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Leukemia, Myeloid; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): November 30, 2040
• Study Completion (Estimated): January 30, 2041
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)