Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

T-cell Acute Lymphoblastic Leukemia Clinical Trial

— CARxALL  

Official title:

Safety and Efficacy of hCD1a-CAR T (OC-1) Therapy, in Patients With Relapsed/Refractory (R/R) T-cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679895
• Other study ID #: OC-01-21001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 31, 2023
• Est. completion date: January 25, 2026

Study information

• Verified date: April 2024
• Source: OneChain Immunotherapeutics
• Contact: Wilmar Castillo
• Phone: 34 93 403 58 62
• Email: wilmar[@]onechaintx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

First in humans, exploratory, open-label, single-arm, multicentre, non-competitive, dose escalation study to assess the safety and efficacy of CD1a-CAR T therapy in patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LL)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 25, 2026
• Est. primary completion date: June 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

1. Children older than 2 years or adults, male and female in both groups.

2. Patients CD1a antigen blast expression =20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.

3. R/R CD1a-positive T-ALL/LL patients, including morphologic or MRD-detectable (=1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines:

1. Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT)

2. Primary refractoriness, defined as either morphologic persistence or detectable MRD (=1x10-4) after two standard therapy lines, making the patient not candidate for allo-HSCT.

3. Refractory first relapse.

4. Second or further relapse.

4. Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.

Exclusion Criteria:

1. Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.

2. Allo-HSCT within a timeframe <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).

3. Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.

4. Active bacterial, fungal or viral infection not controlled by adequate treatment.

5. Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.

6. Women who are pregnant (positive urine/blood pregnancy test) or lactating.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• T-cell Acute Lymphoblastic Leukemia

Intervention

Biological:
• CD1a-CAR T
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

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona
Spain	Hospital Sant Joan de Déu	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
OneChain Immunotherapeutics	BioClever 2005 S.L., Hospital Clinic of Barcelona, Hospital Sant Joan de Deu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Non-relapse treatment-related mortality (NRM)	Non-relapse treatment-related mortality (NRM)	1 year
Primary	Number of adverse events of special interest (AESI)	Number of adverse events of special interest (AESI)	1 year
Primary	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
Primary	Incidence of the treatment-related dermatological events	Incidence of the treatment-related dermatological events	1 year
Primary	Number of patients developing dose limiting toxicity (DLT)	Number of patients developing dose limiting toxicity (DLT)	first 28 days after infusion
Secondary	Remission rate	Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment.	1 year
Secondary	Response rates	Percentage of patients presenting CR, CRi, Complete remission duration (CRD), morphologic leukaemia-free status (MLFS), and no remission (NR).	1 year
Secondary	Duration of remission	The duration of the remission will be assessed from the first documented date of remission status until progression (in days)	1 year
Secondary	Minimal residual disease (MRD) response	Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4).	1 year
Secondary	Progression-free survival (PFS)	time since the first OC-1 administration to the documented loss of response.	1 year
Secondary	Overall survival	Overall survival time since first OC-1 administration to date of death.	1 year
Secondary	Persistence of OC-1	• 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.	1 year