Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05679895

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Clínic, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Number of adverse events grade III-IV

    Time frame: 1 year particularly the first 28 days after infusion

    Number of adverse events grade III-IV using common toxicity criteria (CTC)

  2. Incidence of severe Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS)

    Time frame: 1 year particularly the first 28 days after infusion

    Incidence of severe Cytokine release syndrome (CRS) (≥ grade III) and Immune effector cell-associated neurotoxicity syndrome (ICANS) (≥ grade II)

  3. Non-relapse treatment-related mortality (NRM)

    Time frame: 1 year

    Non-relapse treatment-related mortality (NRM)

  4. Number of adverse events of special interest (AESI)

    Time frame: 1 year

    Number of adverse events of special interest (AESI)

  5. Assessment of the immunological homeostasis

    Time frame: 1 year

    Assessment of the immunological homeostasis, through the identification of lymphocytes subpopulations by flow cytometry at each study timepoint.

  6. Incidence of the treatment-related dermatological events

    Time frame: 1 year

    Incidence of the treatment-related dermatological events

  7. Number of patients developing dose limiting toxicity (DLT)

    Time frame: first 28 days after infusion

    Number of patients developing dose limiting toxicity (DLT)

Secondary outcomes

  1. Remission rate

    Time frame: 1 year

    Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment.

  2. Response rates

    Time frame: 1 year

    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.

  3. Complete remission duration (CRD)

    Time frame: 1 year

    The time from the first documented date of complete remission until disease progression (in days)

  4. Duration of remission

    Time frame: 1 year

    The duration of the remission will be assessed from the first documented date of remission status until progression (in days)

  5. Minimal residual disease (MRD) response

    Time frame: 1 year

    Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4).

  6. Progression-free survival (PFS)

    Time frame: 1 year

    Time since the first OC-1 administration to the documented loss of response.

  7. Overall survival

    Time frame: 1 year

    Overall survival time since first OC-1 administration to date of death.

  8. Persistence of OC-1

    Time frame: 1 year

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Astier

CONTACT

[email protected]

Wilmar Castillo

CONTACT

[email protected]

34 93 403 58 62

Sponsors and collaborators

Lead sponsor

OneChain Immunotherapeutics

Industry

Collaborators

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

Registry information

Official study 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

Acronym: CARxALL

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 11, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.