The PACMAN-Hu19 Trial: a Study of the Safety and Feasibility of Locally Produced, CD19-targeted aā¦ (NCT07020260) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
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
Netherlands18 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range1 Year ā 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. 1-45 years of age.
ā. Patients with relapsed or refractory CD19+ hematological malignancies including, but not limited to:
ā. 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.
ā. 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).
ā. Measurable disease:
ā. For B-NHL at least one measurable lesion according to the Lugano classification.
ā. 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.
ā. Patients must have exhausted or are ineligible for all registered therapeutic options with curative potential.
Exclusion criteria
ā. Patients with symptomatic CNS involvement will be excluded. After resolution and control of symptoms, patients can be rescreened.
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What they're measuring
1
Recommended phase 2 dose (RP2D)
Timeframe: Within 28 days after huCAR19 infusion.
Trial details
NCT IDNCT07020260
SponsorPrincess Maxima Center for Pediatric Oncology
. Active uncontrolled or life-threatening infections.
ā. 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.
ā. Absolute neutrophil count \<0.5x109/L unless caused by underlying disease.
ā. Platelet count \<25x109/L unless caused by underlying disease.
ā. Bilirubin and/or transaminases ā¤ 2.5 x ULN, unless caused by underlying disease.
ā. Renal insufficiency, defined as:
ā. For adults (ā„18 years) glomerular filtration rate (GFR) \< 45 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation: