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Recruiting NCT05679895

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

Phase I Interventional T-cell Acute Lymphoblastic Leukemia Lymphoblastic T-Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD1a-CAR T.
Who it may be relevant to
Registry conditions: T-cell Acute Lymphoblastic Leukemia, Lymphoblastic T-Cell Lymphoma. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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)

Interventions

  • 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

Primary outcome measures

  • Number of adverse events grade III-IV [Time frame: 1 year particularly the first 28 days after infusion]
  • 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]
  • Non-relapse treatment-related mortality (NRM) [Time frame: 1 year]
  • Number of adverse events of special interest (AESI) [Time frame: 1 year]
  • Assessment of the immunological homeostasis [Time frame: 1 year]
  • Incidence of the treatment-related dermatological events [Time frame: 1 year]
  • Number of patients developing dose limiting toxicity (DLT) [Time frame: first 28 days after infusion]
Secondary outcome measures (8)
  • Remission rate [Time frame: 1 year]
  • Response rates [Time frame: 1 year]
  • Complete remission duration (CRD) [Time frame: 1 year]
  • Duration of remission [Time frame: 1 year]
  • Minimal residual disease (MRD) response [Time frame: 1 year]
  • Progression-free survival (PFS) [Time frame: 1 year]
  • Overall survival [Time frame: 1 year]
  • Persistence of OC-1 [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Hospital Clínic — Barcelona
  • Hospital Sant Joan de Déu — Barcelona

Identifiers

NCT: NCT05679895 · OC-01-21001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗