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Long-term Follow-up study for relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LL) patients previously treated with OC-1 cells.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516617-20-00
Acronym
OC-01-23002
Enrollment
20
Registered
2025-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-11

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

Conditions

T-cell Acute Lymphoblastic Leukemia, T-cell acute lymphoblastic Lymphoma

Brief summary

Number of adverse events grade III-IV, related or possibly related, using Common Toxicity Criteria for Adverse Events (CTCAE) version 5, Proportion of patients with: - New malignancies. - Incidence/exacerbation of pre-existing neurologic disorder. - New incidence or exacerbation of a prior rheumatologic or other ATMP-CLINICAL TRIAL PROTOCOL OC-01-23002 EU CT Number: 2024-516617-20-00 Page 6 de 39 Protocol Version 1, 4 november 2024 autoimmune disorder. - New incidence of a hematologic disorder. - New incidence of infection (potentially product-related)- - New incidence of skin disorder

Detailed description

Overall survival following OC-1 cell therapy infusion, Progression-free survival, Progression-free survival in patients who did not received HSCT after OC-1 infusion, Proportion of patients who received an HSCT post OC-1 infusion, Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR. Genomic copy number integrations of the CAR in peripheral blood (PB) T cells and percentage of CD1a CAR-expressing T cells.

Interventions

Sponsors

Onechain Immunotherapeutics S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of adverse events grade III-IV, related or possibly related, using Common Toxicity Criteria for Adverse Events (CTCAE) version 5, Proportion of patients with: - New malignancies. - Incidence/exacerbation of pre-existing neurologic disorder. - New incidence or exacerbation of a prior rheumatologic or other ATMP-CLINICAL TRIAL PROTOCOL OC-01-23002 EU CT Number: 2024-516617-20-00 Page 6 de 39 Protocol Version 1, 4 november 2024 autoimmune disorder. - New incidence of a hematologic disorder. - New incidence of infection (potentially product-related)- - New incidence of skin disorder

Secondary

MeasureTime frame
Overall survival following OC-1 cell therapy infusion, Progression-free survival, Progression-free survival in patients who did not received HSCT after OC-1 infusion, Proportion of patients who received an HSCT post OC-1 infusion, Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR. Genomic copy number integrations of the CAR in peripheral blood (PB) T cells and percentage of CD1a CAR-expressing T cells.

Countries

Spain

Outcome results

None listed

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