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)

Conditions

B-cell Non Hodgkin Lymphoma, B-cell precursor ALL

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGMB-huCART19.1

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed