Actively Recruiting
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
Led by OneChain Immunotherapeutics · Updated on 2026-03-11
20
Participants Needed
2
Research Sites
252 weeks
Total Duration
On this page
Sponsors
O
OneChain Immunotherapeutics
Lead Sponsor
B
BioClever 2005 S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 years or older or adults, male and female.
- Patients must have 20% or more CD1a antigen expression on cancer cells confirmed by flow cytometry or histology.
- Patients with relapsed or refractory CD1a-positive T-ALL/LL, including failure to achieve remission after at least two chemotherapy cycles, first or subsequent relapse after standard therapy, relapse after stem cell transplant, or primary refractoriness.
- Patients without reproductive capacity or willing to use effective contraception during the study.
You will not qualify if you...
- Uncontrolled organ dysfunction such as heart (ejection fraction <45%), lung, liver, kidney, or central nervous system problems.
- Stem cell transplant within the last 3 months or ongoing immunosuppressive treatment for graft versus host disease.
- Uncontrolled epilepsy or severe central nervous system disease.
- Active uncontrolled infections including bacterial, fungal, or viral.
- Known HIV, active hepatitis B or C infection.
- Pregnant or breastfeeding women.
- Severe illness or medical condition preventing protocol management.
- Serious autoimmune or immunodeficiency diseases.
- Participation in another experimental drug trial within 6 weeks before infusion.
- Other uncontrolled cancers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Clínic
Barcelona, Spain
Actively Recruiting
2
Hospital Sant Joan de Déu
Barcelona, Spain
Actively Recruiting
Research Team
W
Wilmar Castillo
CONTACT
L
Laura Astier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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