Measurable residual disease driven strategy for one or two infusions of nonviral, transposon-manipulated CARCIK CD19 cells. A Phase II study in pediatric and adult patients with relapsed/refractory B cell precursor ALL (BCP-ALL).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519394-19-00

Enrollment

Registered

2024-12-10

Start date

2021-09-22

Completion date

Unknown

Last updated

2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B cell precursor Acute Lymphoblastic Leukemia

Brief summary

ORR at 28 days after the first CARCIK-CD19 administration, DOR from day 70 for patients who achieved and maintained remission after the first or the second CARCIK-CD19 administration

Detailed description

Overall survival (i. e. time from infusion to death), Safety of the second administration of allogeneic CARCIK-CD19 cells, Safety of autologous CARCIK-CD19 cells, Safety of cordblood CARCIK-CD19 cells.

Interventions

DRUGPTG-CARCIK-CD19

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR at 28 days after the first CARCIK-CD19 administration, DOR from day 70 for patients who achieved and maintained remission after the first or the second CARCIK-CD19 administration	—

Secondary

Measure	Time frame
Overall survival (i. e. time from infusion to death), Safety of the second administration of allogeneic CARCIK-CD19 cells, Safety of autologous CARCIK-CD19 cells, Safety of cordblood CARCIK-CD19 cells.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026