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The PACMAN-Hu19 Trial: a Study of the Safety and Feasibility of Locally Produced, CD19-targeted and Human CAR T-cell Therapy in Children and Young Adults With Relapsed or Refractory B-cell Malignancies

NCT07020260 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-13

No results posted yet for this study

Summary

PACMAN is a phase I/II single arm, open-label, multi-center study evaluating the safety of human CD19 CAR-T (huCAR19) produced locally using the Miltenyi Prodigy in children, adolescents and young adults with relapsed/refractory CD19+ hematological malignancies for whom no standard of care treatment is available.

Conditions

Interventions

OTHER

CAR T-cell and Cellular Therapies

A single IV infusion of huCAR 19 T-cells on day 0. In phase I 3 dose levels are tested to determine the RP2D.

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Miltenyi Biomedicine GmbH

    collaborator INDUSTRY

  • University Medical Center Utrecht (UMCU)

    collaborator UNKNOWN

  • Princess Maxima Center for Pediatric Oncology

    lead OTHER

Principal Investigators

  • Friso Calkoen, MD, PhD · Princess Maxima Center for Pediatric Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-09-01
Completion
2028-09-01

Countries

  • Netherlands

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 NCT07020260 on ClinicalTrials.gov