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Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker

NCT04633148 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-04-23

No results posted yet for this study

Summary

This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug UniCAR02-T-pPSMA in patients with progressive disease after standard systemic therapy in castration-resistant prostate cancers with positive PSMA marker. The UniCAR02-T-pPSMA drug is a combination of a cellular component (UniCAR02-T) with a recombinant antibody derivative (TMpPSMA) which together forms the active drug.

Conditions

Interventions

DRUG

Cyclophosphamide (Non-IMP)

Intravenous infusion for 3 days

DRUG

Fludarabine (Non-IMP)

Intravenous infusion for 3 days

DRUG

UniCAR02-T-pPSMA

Intravenous Infusion for 21 days

DRUG

UniCAR02-T (IMP)

Intravenous infusion of single dose

Sponsors & Collaborators

  • PHARMALOG Institut für klinische Forschung GmbH

    collaborator UNKNOWN

  • AvenCell Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Ralf Bargou, Prof. · Wuerzburg University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2024-03-28
Completion
2024-03-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633148 on ClinicalTrials.gov