Safety and Efficacy of OC-1 Cell Therapy in Patients With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma
- Conditions
- Children older than 2 years or adults, male and female, with refractory or relapsed T-cell acute lymphoblastic leukaemia/lymphoblastic lymphoma (T-ALL/LL).MedDRA version: 21.1Level: PTClassification code 10036546Term: Precursor T-lymphoblastic lymphoma/leukaemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2021-002333-42-ES
- Lead Sponsor
- OneChain Immunotherapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
1.Children older than 2 years or adults, male and female in both groups.
2.Patients CD1a positive antigen blast expression =20%, 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:
-Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
-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.
-Refractory first relapse.
-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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
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 time frame <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 (urine/blood pregnancy test positive) or lactating.
7.Severe illness or medical condition, which would not permit the patient to be managed according to the protocol.
8.Suffering from a serious autoimmune disease or immunodeficiency disease.
9.The patient participated in other experimental drug clinical trial within 6 weeks prior to enrollment.
10.Other non-controlled concomitant neoplasms.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method