Safety and Efficacy of OC-1 Therapy in Patients With R/R... | NCT05679895

NCT05679895

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
BioClever 2005 S.L.	OTHER
Hospital Clinic of Barcelona	OTHER
Hospital Sant Joan de Deu	OTHER
Astrum CRO, S.L.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: CD1a-CAR T	Experimental	CD1a CAR T cells transduced with a lentiviral vector to express CD1a chimeric receptor domain on T cells administered with a dose-escalation approach.	Biological: CD1a-CAR T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CD1a-CAR T	Biological	Autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express CD1a chimeric antigen receptor administered by intravenous infusion following a dose-escalation approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse events grade III-IV	Number of adverse events grade III-IV using common toxicity criteria (CTC)	1 year particularly the first 28 days after infusion
Incidence of severe Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS)	Incidence of severe Cytokine release syndrome (CRS) (≥ grade III) and Immune effector cell-associated neurotoxicity syndrome (ICANS) (≥ grade II)	1 year particularly the first 28 days after infusion
Non-relapse treatment-related mortality (NRM)	Non-relapse treatment-related mortality (NRM)	1 year
Number of adverse events of special interest (AESI)	Number of adverse events of special interest (AESI)	1 year
Assessment of the immunological homeostasis	Assessment of the immunological homeostasis, through the identification of lymphocytes subpopulations by flow cytometry at each study timepoint.	1 year
Incidence of the treatment-related dermatological events	Incidence of the treatment-related dermatological events	1 year
Number of patients developing dose limiting toxicity (DLT)	Number of patients developing dose limiting toxicity (DLT)

Secondary Outcomes

Measure	Description	Time Frame
Remission rate	Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment.	1 year
Response rates	Percentage of patients presenting CR, CRi, morphologic leukaemia-free status (MLFS), and no remission (NR). In the presence of extramedullary disease, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe the response.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Children older than 2 years or adults, male and female in both groups.
Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.
R/R CD1a-positive T-ALL/LL patients defined as:
- Failure to achieve morphological complete remission (> 5% bone marrow blasts) or persistence of extramedullary disease after at least two cycles of chemotherapy.
- First or subsequent relapse, including morphologic or MRD-detectable (≥1x10-4 ) bone marrow and/or extramedullary relapses after at least one standard frontline therapy.
- Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT).
- Primary refractoriness, defined as either morphologic persistence or detectable MRD (≥1x10-4 ) after at least two cycles of chemotherapy, making the patient not candidate for allo-HSCT.
Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.

Exclusion Criteria:

Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).
Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.
Active bacterial, fungal or viral infection not controlled by adequate treatment.
Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.
Women who are pregnant (urine/blood pregnancy test positive) or lactating.
Severe illness or medical condition, which would not permit the patient to be managed according to the protocol.
Suffering from a serious autoimmune disease or immunodeficiency disease.
The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
Other non-controlled concomitant neoplasms.

Name	Role	Phone	Extension	Email
Wilmar Castillo	Contact	34 93 403 58 62		wilmar@onechaintx.com
Laura Astier	Contact			laura.astier@astrumcro.com

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type