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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 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

The PACMAN-hu19 Trial: a Phase I/II Study to Investigate the Safety and Feasibility of Point-of-care Human CD19 Targeting CAR T-cells in Pediatric and Young Adult Patients With Relapsed or Refractory B-cell Malignancies

NCT07020260•Princess Maxima Center for Pediatric Oncology

View on ClinicalTrials.gov

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.

Detailed Description

In this study patients aged 1-45 years with relapsed or refractory CD19+ hematological malignancies (B-NHL or BCP-ALL) are treated with a single dose of huCAR19 T-cells. After consent and screening, patients will undergo leukapheresis to harvest autologous PBMCs. During the CAR T-cell production, patients receive lymphodepleting chemotherapy after which the huCAR19 T-cells are administered. In phase I the aim is to establish the RP2D, the protocol will then be extended to a phase II.

Eligibility

Age

1 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 1-45 years of age.
•2. Patients with relapsed or refractory CD19+ hematological malignancies including, but not limited to:
•1. B-NHL such as Burkitt lymphoma(BL), de novo or transformed diffuse large B cell lymphoma (DLBCL), lymphoblastic lymphoma (LBL), primary mediastinal B cell lymphoma (PMBCL) or indolent lymphoma types with no access to commercially available CAR T-cell therapy or for whom the current production time for commercially available CAR T-cell therapy is not acceptable based on medical need.
•OR
•2. B-cell precursor ALL failing commercially available CAR T-cell therapy, or for BCP-ALL indications with no access to commercially available CAR T-cell therapy, or for whom the current production time for commercially available CAR T-cell therapy is not acceptable based on urgent medical need (the latter needs to be confirmed by the sponsor).
•3. Measurable disease:
•1. For B-NHL at least one measurable lesion according to the Lugano classification.
•2. For BCP-ALL at least 0.1% (=10-3) of blasts should be present in the bone marrow measured by molecular MRD, morphology or flow cytometry at screening.
•4. Patients must have exhausted or are ineligible for all registered therapeutic options with curative potential.
•5. Adequate performance score:
+8 more criteria

Exclusion Criteria

•1. Patients with symptomatic CNS involvement will be excluded. After resolution and control of symptoms, patients can be rescreened.
•2. Active uncontrolled or life-threatening infections.
•3. Infection with HTLV-1, HTLV-2, HIV-1, HIV-2, hepatitis B (HbsAg positive) or hepatitis C (anti-HCV positive). Chronic controlled hepatitis B or C infection with undetectable viral load or controlled HIV infection with viral load \<50 IU/ml and CD4+ T-cell count \>200/ml may be considered when antiviral prophylaxis or therapy can be administered.
•4. Absolute neutrophil count \<0.5x109/L unless caused by underlying disease.
•5. Platelet count \<25x109/L unless caused by underlying disease.
•6. Bilirubin and/or transaminases ≤ 2.5 x ULN, unless caused by underlying disease.
•7. Renal insufficiency, defined as:
•1. For adults (≥18 years) glomerular filtration rate (GFR) \< 45 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation:
•predicted GFR (ml/min/1.73 m2) = 186 x (serum creatinine in umol/L / 88.7) - 1.154 x (age in years) - 0.203 x (0.742 if patient is female) x (1.212 if patient is black).
•2. For children (\<18 years) a serum creatinine based on gender/age as follows (in µmol/l):
+12 more criteria

Locations (2)

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Princess Máxima Center for pediatric oncology

Utrecht, Utrecht, Netherlands

Key Dates

Start Date

September 1, 2025

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2028

Last Updated

June 13, 2025

Enrollment

ESTIMATED participants

Conditions

LeukemiaLymphoma

Interventions

CAR T-cell and Cellular Therapies

OTHER

Contacts

Ellis van Liempt, PhD

CONTACT

0031 88 972 72 72 pacman@prinsesmaximacentrum.nl

Marieke Kietselaer

CONTACT

0031 88 972 72 72 pacman@prinsesmaximacentrum.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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