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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)
EU CTIS ID: 2024-514591-40-00
What this study is testing
To assess the safety of OC-1 in patients with primary relapsed/refractory CD1a-positive T-ALL/LL.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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, 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.
- Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.
You likely can't join if
- Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
- Other non-controlled concomitant neoplasms.
- 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.
See the full eligibility criteria
- 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, 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.
- Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.
- Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
- Other non-controlled concomitant neoplasms.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.