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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

First listed

Mar 16, 2026

Start date

Jan 29, 2026

Status verified

Mar 2026

Primary completion

Nov 30, 2040

Completion

Jan 30, 2041

Study Design

Enrollment

178 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

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 ]

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