T-cell Acute Lymphoblastic LeukemiaPhase 1CARxALLNCT05679895
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
A Phase 1 study testing CD1a-CAR T in people with T-cell Acute Lymphoblastic Leukemia and Lymphoblastic T-Cell Lymphoma, run by OneChain Immunotherapeutics at 2 sites in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, Lymphoblastic T-Cell Lymphoma
- What is being tested?
- CD1a-CAR T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 31 Jan 2023to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children older than 2 years or adults, male and female in both groups.
- Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.
- 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.
- Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.
Who cannot join
- Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
- Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).
- Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.
- Active bacterial, fungal or viral infection not controlled by adequate treatment.
- Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.
- Women who are pregnant (urine/blood pregnancy test positive) or lactating.
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- Severe illness or medical condition, which would not permit the patient to be managed according to the protocol.
- Suffering from a serious autoimmune disease or immunodeficiency disease.
- The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
- Other non-controlled concomitant neoplasms.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Astier contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clínic
Barcelona
Nuria Martinez
- Recruiting
Hospital Sant Joan de Déu
Barcelona
Susana Rives, 34 93 280 40 00
About this study
Official title: 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
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)
- Being tested
- CD1a-CAR T
- Keywords
- CAR-T-based therapies, CD1a
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD1a-CAR TBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CD1a-CAR T | Experimental | CD1a CAR T cells transduced with a lentiviral vector to express CD1a chimeric receptor domain on T cells administered with a dose-escalation approach. Receives: Biological: CD1a-CAR T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events grade III-IV
Number of adverse events grade III-IV using common toxicity criteria (CTC)
Measured: 1 year particularly the first 28 days after infusion
Incidence of severe Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS)
Incidence of severe Cytokine release syndrome (CRS) (≥ grade III) and Immune effector cell-associated neurotoxicity syndrome (ICANS) (≥ grade II)
Measured: 1 year particularly the first 28 days after infusion
Non-relapse treatment-related mortality (NRM)
Non-relapse treatment-related mortality (NRM)
Measured: 1 year
Number of adverse events of special interest (AESI)
Number of adverse events of special interest (AESI)
Measured: 1 year
Assessment of the immunological homeostasis
Assessment of the immunological homeostasis, through the identification of lymphocytes subpopulations by flow cytometry at each study timepoint.
Measured: 1 year
Incidence of the treatment-related dermatological events
Incidence of the treatment-related dermatological events
Measured: 1 year
Number of patients developing dose limiting toxicity (DLT)
Number of patients developing dose limiting toxicity (DLT)
Measured: first 28 days after infusion
Secondary outcomes (8)
Remission rate
Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment.
Measured: 1 year
Response rates
Percentage of patients presenting CR, CRi, morphologic leukaemia-free status (MLFS), and no remission (NR). In the presence of extramedullary disease, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe the response.
Measured: 1 year
Complete remission duration (CRD)
The time from the first documented date of complete remission until disease progression (in days)
Measured: 1 year
Duration of remission
The duration of the remission will be assessed from the first documented date of remission status until progression (in days)
Measured: 1 year
Minimal residual disease (MRD) response
Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4).
Measured: 1 year
Progression-free survival (PFS)
Time since the first OC-1 administration to the documented loss of response.
Measured: 1 year
Overall survival
Overall survival time since first OC-1 administration to date of death.
Measured: 1 year
Persistence of OC-1
- Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR. Genomic copy number integrations of the CAR in peripheral blood (PB) T cells and percentage of CD1a CAR-expressing T cells.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start31 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OneChain Immunotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioClever 2005 S.L., Hospital Clinic of Barcelona, Hospital Sant Joan de Deu, Astrum CRO, S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679895
- Sponsor's protocol ID
- OC-01-21001
- Acronym
- CARxALL
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05679895
- Acronym / sponsor ID
- CARxALL / OC-01-21001
- Keywords
- CAR-T-based therapies, CD1a
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- OneChain ImmunotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- BioClever 2005 S.L., Hospital Clinic of Barcelona, Hospital Sant Joan de Deu, Astrum CRO, S.L.
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: CD1a-CAR T | Experimental | Biological: CD1a-CAR TCD1a CAR T cells transduced with a lentiviral vector to express CD1a chimeric receptor domain on T cells administered with a dose-escalation approach. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Children older than 2 years or adults, male and female in both groups.
- Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.
- R/R CD1a-positive T-ALL/LL patients defined as:
- Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.
Key exclusion criteria (10 listed)
- Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
- Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).
- Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.
- Active bacterial, fungal or viral infection not controlled by adequate treatment.
- Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD1a-CAR TAutologous 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 | Biological | Experimental: CD1a-CAR T |
Primary outcome
Number of adverse events grade III-IV
Time frame: 1 year particularly the first 28 days after infusion
Number of adverse events grade III-IV using common toxicity criteria (CTC)
Incidence of severe Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS)
Time frame: 1 year particularly the first 28 days after infusion
Incidence of severe Cytokine release syndrome (CRS) (≥ grade III) and Immune effector cell-associated neurotoxicity syndrome (ICANS) (≥ grade II)
Non-relapse treatment-related mortality (NRM)
Time frame: 1 year
Non-relapse treatment-related mortality (NRM)
Number of adverse events of special interest (AESI)
Time frame: 1 year
Number of adverse events of special interest (AESI)
Assessment of the immunological homeostasis
Time frame: 1 year
Assessment of the immunological homeostasis, through the identification of lymphocytes subpopulations by flow cytometry at each study timepoint.
Incidence of the treatment-related dermatological events
Time frame: 1 year
Incidence of the treatment-related dermatological events
Number of patients developing dose limiting toxicity (DLT)
Time frame: first 28 days after infusion
Number of patients developing dose limiting toxicity (DLT)
8 secondary outcomes
Remission rate
Time frame: 1 year
Response rates
Time frame: 1 year
Complete remission duration (CRD)
Time frame: 1 year
Duration of remission
Time frame: 1 year
Minimal residual disease (MRD) response
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival
Time frame: 1 year
Persistence of OC-1
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Astier contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD1a-CAR T in people with T-cell Acute Lymphoblastic Leukemia and Lymphoblastic T-Cell Lymphoma, run by OneChain Immunotherapeutics at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wilmar Castillo (34 93 403 58 62, wilmar@onechaintx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events grade III-IV (time frame: 1 year particularly the first 28 days after infusion). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.