RecruitingPhase 1NCT05679895

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


Sponsor

OneChain Immunotherapeutics

Enrollment

20 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new therapy called OC-1 for patients with a rare and aggressive type of leukemia called T-ALL or T-cell lymphoblastic lymphoma (T-LL) that has relapsed (come back) or stopped responding to prior treatments. OC-1 is designed to target a specific protein (CD1a) found on the surface of these cancer cells. **You may be eligible if...** - You are older than 2 years (children and adults are eligible) - Your leukemia or lymphoma cells express a specific marker called CD1a (confirmed by testing) - Your cancer has relapsed or failed to respond to at least two rounds of chemotherapy - You are not pregnant and are using effective contraception if applicable **You may NOT be eligible if...** - You have significant heart, lung, liver, kidney, or brain problems - You had a stem cell transplant within the past 3 months or still need anti-rejection medications - You have uncontrolled epilepsy or severe nervous system disease - You have an active, uncontrolled infection or HIV/active hepatitis - You are pregnant or breastfeeding - You have another uncontrolled cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD1a-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


Locations(2)

Hospital Clínic

Barcelona, Spain

Hospital Sant Joan de Déu

Barcelona, Spain

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NCT05679895


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