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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors

NCT02756845

Advanced Non CNS Tumors

COMPLETED PHASE1

"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia

NCT02074657

Relapsed/Refractory Paediatric Acute Leukaemia

COMPLETED PHASE2

The Predictability of CD19 Expression Across Primitive Cellular Fractions of Relapsed B-ALL on Outcomes of CD19-targeted CAR T-cells

NCT06993766

Relapsed B-ALL CAR T-cells CD19-directed CAR T-cell Therapy

NOT_YET_RECRUITING

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

NCT06184009

Pediatric Acute Lymphoblastic Leukemia

RECRUITING PHASE2

Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma

NCT01944982

Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma

TERMINATED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

T-cell Acute Lymphoblastic Leukemia Lymphoblastic T-Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: CD1a-CAR T

CD1a CAR T cells transduced with a lentiviral vector to express CD1a chimeric receptor domain on T cells administered with a dose-escalation approach.

Group Type EXPERIMENTAL

CD1a-CAR T

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CD1a-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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No