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

Sponsor
Princess Maxima Center for Pediatric Oncology
Study ID
NCT07020260
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • CAR T-cell and Cellular Therapies — OTHER
    A single IV infusion of huCAR 19 T-cells on day 0. In phase I 3 dose levels are tested to determine the RP2D.

Study Details

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.

Key Dates

First listed
Jun 13, 2025
Start date
Sep 1, 2025
Status verified
Jun 2025
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: huCAR19 T-cells
    Participants will receive one single dose of huCAR19 T-cell infusion on day 0 of the treatment.

Primary Outcome Measure

Recommended phase 2 dose (RP2D) [ Time Frame: Within 28 days after huCAR19 infusion. ]

Central Contacts

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