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LeukemiaPhase 1/2PACMANNCT07020260

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

A Phase 1/2 study testing CAR T-cell and Cellular Therapies in people with Leukemia and Lymphoma, run by Princess Maxima Center for Pediatric Oncology at 2 sites in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 45 years
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
CAR T-cell and Cellular Therapies
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesNetherlands
Study dates
1 Sep 2025to 1 Sep 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 1-45 years of age.
  • Patients with relapsed or refractory CD19+ hematological malignancies including, but not limited to:
  • 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
  • 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).
  • Measurable disease:
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  • For B-NHL at least one measurable lesion according to the Lugano classification.
  • 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.
  • Patients must have exhausted or are ineligible for all registered therapeutic options with curative potential.
  • Adequate performance score:
  • Children <16 years: Lansky performance status ≥ 60 .
  • Children age ≥16 years and <18 years Karnofsky performance status ≥ 60.
  • Adults ≥18 years ECOG performance status 0, 1 or 2 (ECOG performance status 3 is allowed only when due to underlying disease).
  • Patients from childbearing potential must be willing and able to use highly effective methods of birth control from first chemotherapy infusion through 12 months after administering the last study treatment.
  • Patients must be willing to abstain from breast feeding through 12 months after administering the last study treatment.
  • Patients must agree to refrain from donating blood or organs following treatment with huCAR19 T-cells.
  • Written informed consent per local law and regulations.
  • Additional inclusion criteria phase I part of the study:
  • The first three patients in the phase I part of the study must be aged 12-45 years, thereafter patients of any age between 1-45 years can be recruited once surrogate endpoint of BCA is reached in ≥60% patients in previous or current dose level and ≤1 DLT occurred at the previous dose level.

Who cannot join

  • Patients with symptomatic CNS involvement will be excluded. After resolution and control of symptoms, patients can be rescreened.
  • Active uncontrolled or life-threatening infections.
  • 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.
  • Absolute neutrophil count <0.5x109/L unless caused by underlying disease.
  • Platelet count <25x109/L unless caused by underlying disease.
  • Bilirubin and/or transaminases ≤ 2.5 x ULN, unless caused by underlying disease.
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  • Renal insufficiency, defined as:
  • 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).
  • For children (<18 years) a serum creatinine based on gender/age as follows (in µmol/l):
  • Age Male Female 0 to < 2 years 53 70 2 to < 6 years 70 70 6 to < 10 years 88 88 10 to < 13 years 106 106 13 to < 16 years 132 123 16 to < 19 years 150 123
  • Inadequate pulmonary function defined as baseline oxygen saturation <92%, if not caused by underlying disease.
  • Inadequate cardiac function:
  • Unstable angina or unstable cardiac arrhythmias.
  • NYHA classification >II.
  • LVSF <28% or LVEF <45% confirmed by echocardiogram or MUGA scan.
  • Concurrent malignancy requiring treatment of having been treated <3 months before screening except for curatively treated basal cell carcinoma of the skin.
  • Pregnant women.
  • Patients unable to participate in the study according to investigator judgement.
  • Patients not willing or unable to adhere to protocol guidelines or follow-up.
  • Treatment with allogeneic stem cell transplantation <12 weeks from screening or DLI <4 weeks from screening or active GVHD requiring systemic treatment. Cutaneous GVHD requiring only topical steroids is allowed.
  • Hypersensitivity to the active substance

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ellis van Liempt, PhD contact

0031 88 972 72 72

pacman@prinsesmaximacentrum.nl

Marieke Kietselaer contact

0031 88 972 72 72

pacman@prinsesmaximacentrum.nl

Netherlands2 sites

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3584 CX

    Rimke Oostvogels, MD, PhD, 003188 75 558 78, hemat-research@umcutrecht.nl

    Linda van Dommelen, 003188 75 558 78, hemat-research@umcutrecht.nl

  • Princess Máxima Center for pediatric oncology

    Utrecht, Utrecht, 3584CS

    Friso Calkoen, MD, PhD, 0031889227272, pacman@prinsesmaximacentrum.nl

    Ellis van Liempt, PhD, 0031889727272, pacman@prinsesmaximacentrum.nl

Other trials in Netherlands

About this study

Official title: 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

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.

Read the 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.

Conditions
Leukemia, Lymphoma
Being tested
CAR T-cell and Cellular Therapies
Keywords
CAR T-cell Therapy, relapsed B-cell malignancies, refactory B-cell malignancies, B-NHL, B-cell ALL
Medical subject headings
Leukemia, Lymphoma, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAR T-cell and Cellular TherapiesOther

    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 groups in NCT07020260
Study groupRoleWhat they receive
huCAR19 T-cellsExperimentalParticipants will receive one single dose of huCAR19 T-cell infusion on day 0 of the treatment.
Receives: Other: CAR T-cell and Cellular Therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase 2 dose (RP2D)

    The endpoint to measure this primary objective is the incidence of dose limiting toxicities (DLTs).

    Measured: Within 28 days after huCAR19 infusion.

Secondary outcomes (4)

  1. To assess preliminary activity at day 28 for the BCP-ALL cohort and the overall response rate for the B-NHL cohort

    For BCP-ALL: the MRD-negative CR rate. For B-NHL: the overall response rate (ORR, CR +PR according to Lugano criteria).

    Measured: For BCP-ALL: at day 28. For B-NHL: at day 90.

  2. Duration of response, including the duration of B-cell aplasia

    Number of days until relapse. Number of days until loss of B-cell aplasia defined by ≥ 5 B-cells/µl.

    Measured: from inclusion through study completion

  3. Survival estimates.

    Event free survival (EFS); Overall survival (OS); Cumulative Incidence of Relapse (CIR).

    Measured: Measured at 6 and 12 months.

  4. The feasibility to produce HuCAR19 in the target population.

    Percentage of products fulfilling the release criteria.

    Measured: From day -13 (start of manufacturing) to day 0 (final analysis)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Each subject will receive a single infusion of the huCAR19 CAR T-cells. There will be 3 different dose levels investigated in the PACMAN trial.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07020260
Sponsor's protocol ID
2023-507597-40
Other IDs
2023-507597-40-00, 2023
Acronym
PACMAN
Status last verified
Jun 2025
First submitted
26 Feb 2025
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only IPD used in the results publication.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR T-cell and Cellular Therapies in people with Leukemia and Lymphoma, run by Princess Maxima Center for Pediatric Oncology at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ellis van Liempt, PhD (0031 88 972 72 72, pacman@prinsesmaximacentrum.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase 2 dose (RP2D) (time frame: Within 28 days after huCAR19 infusion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07020260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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