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Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT05679895•OneChain Immunotherapeutics

View on ClinicalTrials.gov

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)

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

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 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.
•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 time frame \<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 (urine/blood pregnancy test positive) or lactating.
•7. Severe illness or medical condition, which would not permit the patient to be managed according to the protocol.
•8. Suffering from a serious autoimmune disease or immunodeficiency disease.
•9. The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
•10. Other non-controlled concomitant neoplasms.

Locations (2)

Hospital Clínic

Barcelona, Spain

Hospital Sant Joan de Déu

Barcelona, Spain

Key Dates

Start Date

January 31, 2023

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

T-cell Acute Lymphoblastic LeukemiaLymphoblastic T-Cell Lymphoma

Interventions

CD1a-CAR T

BIOLOGICAL

Contacts

Wilmar Castillo

CONTACT

34 93 403 58 62 wilmar@onechaintx.com

Laura Astier

CONTACT

laura.astier@astrumcro.com

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

NCT05376111

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T-Cell Acute Lymphoblastic Leukemia/Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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