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

NCT05679895 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • BioClever 2005 S.L.

    collaborator OTHER

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Hospital Sant Joan de Deu

    collaborator OTHER

  • Astrum CRO, S.L.

    collaborator UNKNOWN

  • OneChain Immunotherapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679895 on ClinicalTrials.gov