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

Condition(s) studied

Investigational drug(s) / intervention(s)

UniCAR02-T (IMP) With Targeting Module TM123: No investigational product will be administered

UniCAR02-T-pPSMA: No investigational product will be administered

Allo-RevCAR01- T with Targeting Module R-TM123: No investigational product will be administered

Allo-QuadCAR01-T: No investigational product will be administered

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (5)

More AvenCell Therapeutics, Inc. trials in Germany

Other trials for the same condition