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Trial Title:
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
NCT ID:
NCT05679895
Condition:
T-cell Acute Lymphoblastic Leukemia
Lymphoblastic T-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
CAR-T-based therapies
CD1a
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD1a-CAR T
Description:
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
Arm group label:
Experimental: CD1a-CAR T
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)
Criteria for eligibility:
Criteria:
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, including morphologic or MRD-detectable
(≥1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines:
1. Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
2. Primary refractoriness, defined as either morphologic persistence or detectable
MRD (≥1x10-4) after two standard therapy lines, making the patient not
candidate for allo-HSCT.
3. Refractory first relapse.
4. Second or further relapse.
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 timeframe <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 (positive urine/blood pregnancy test) or lactating.
Gender:
All
Minimum age:
2 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clínic
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Nuria Martinez
Facility:
Name:
Hospital Sant Joan de Déu
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Susana Rives
Phone:
34 93 280 40 00
Start date:
January 31, 2023
Completion date:
January 25, 2026
Lead sponsor:
Agency:
OneChain Immunotherapeutics
Agency class:
Industry
Collaborator:
Agency:
BioClever 2005 S.L.
Agency class:
Other
Collaborator:
Agency:
Hospital Clinic of Barcelona
Agency class:
Other
Collaborator:
Agency:
Hospital Sant Joan de Deu
Agency class:
Other
Source:
OneChain Immunotherapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679895
