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

NCT05679895 | Recruiting Phase 1 DMC

• 1 other identifier: OC-01-21001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

T-cell Acute Lymphoblastic Leukemia; Lymphoblastic T-Cell Lymphoma

Keywords

CAR-T-based therapies; CD1a

Outcome Measures

Primary Outcomes (7)

• 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)

  first 28 days after infusion

Secondary Outcomes (8)

• Remission rate

  1 year

• Response rates

  1 year

• Complete remission duration (CRD)

  1 year

• Duration of remission

  1 year

• Minimal residual disease (MRD) response

  1 year

Study Arms (1)

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

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

Experimental: CD1a-CAR T

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astrum CRO, S.L.: collaborator
• OneChain Immunotherapeutics: lead
• BioClever 2005 S.L.: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Sant Joan de Deu: collaborator

Study Sites (2)

Hospital Clínic

Barcelona, Spain

RECRUITING

Hospital Sant Joan de Déu

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wilmar Castillo

CONTACT

34 93 403 58 62; wilmar@onechaintx.com

Laura Astier

CONTACT

laura.astier@astrumcro.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 11, 2023
• Study Start: January 31, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

ES (2)