A PHASE I/II STUDY TO INVESTIGATE THE SAFETY AND FEASIBILITY OF POINT-OF-CARE HUMAN-CD19 TARGETING CAR T-CELLS IN PAEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL MALIGNANCIES (PACMAN)

Prinses Maxima Centrum voor Kinderoncologie B.V.2 sites in 1 country18 target enrollmentStarted: December 16, 2025Last updated: December 16, 2025

Trial Snapshot

Phase: Phase 1/2
Status: Not yet recruiting
Sponsor
Enrollment: 18
Locations: 2
Primary Endpoint: Dose at which ≤ 1 patients experience a Dose Limiting Toxicity (DLT) within 28 days after CAR T-cell infusion

Study Overview Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

To determine the incidence of DLT within 28 days after CAR T-cel infusion (huCAR19), which will result in the recommended phase 2 dose (RP2D)

Eligibility Criteria

Ages: 0 years to 64 years (18-64 Years, 0-17 Years)
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•1-45 years of age
•Additional inclusion criteria phase I part of the study: The first three patients in the phase 1 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 B-cell Aplasia is reached in ≥60% patients in previous or current dose level.
•Patients with relapsed or refractory CD19+ hematological malignancies (a.o. B-NHL and B-cell precursor)
•Measurable disease (at least one measurable lesion or at least 0.1% of blast in bone marrow)
•Patients must have exhausted or are ineligible for all registered therapeutic options with curative potential.
•Adequate performance score
•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.

Exclusion Criteria

•Patients with symptomatic CNS involvement will be excluded. After resolution and control of symptoms, patients can be rescreened.
•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
•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 <0.5x10E9/L unless caused by underlying disease
•Platelet count <25x10E9/L unless caused by underlying disease
•Bilirubin and/or transaminases ≤ 2.5 x ULN, unless caused by underlying disease.
•Renal insufficiency
•Inadequate pulmonary function defined as baseline oxygen saturation <92%, if not caused by underlying disease.
•Inadequate cardiac function

Outcomes

Primary Outcomes

Dose at which ≤ 1 patients experience a Dose Limiting Toxicity (DLT) within 28 days after CAR T-cell infusion

Secondary Outcomes

For B-ALL: the MRD-negative CR rate at day 28
For B-NHL: the overall response rate (ORR, CR +PR according to Lugano criteria) at day 90
Surrogate endpoint for efficacy: B-cell aplasia (<5 B-cells/µl) at day 28 after infusion
Number of days until relapse
Number of days from CAR T-cell infusion until recovery of B-cells (B-cell recovery is defined as peripheral blood ≥10 CD19+ B-cells/mcL OR ≥1% CD19+ B-cells in the bone marrow. Results must be confirmed on a subsequent test ≥2 weeks apart with timing of B-cell recovery defined as the date of the initial sample
Event free survival (EFS) at 6 and 12 months
Overall Survival (OS) at 6 and 12 months
Cumulative Incidence of Relapse at 6 and 12 months
The percentage of products fulfilling the release criteria

Investigators

Sponsor

Prinses Maxima Centrum voor Kinderoncologie B.V.

Sponsor Class

Hospital/Clinic/Other health care facility

Responsible Party

Principal Investigator

F.G.J. Calkoen MD PhD

Scientific

Prinses Maxima Centrum voor Kinderoncologie B.V.

Study Sites (2)

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