Clinical Trials in Spain / NCT05679895
Recruiting
Phase 1
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
NCT05679895 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
T-cell Acute Lymphoblastic LeukemiaLymphoblastic T-Cell Lymphoma
Investigational drug(s) / intervention(s)
CD1a-CAR T
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
Study 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)
Eligibility
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 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.
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 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 OC-1 infusion.
10. Other non-controlled concomitant neoplasms.
Primary outcome measure(s)
- Number of adverse events grade III-IV — 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) — 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) — 1 year
Non-relapse treatment-related mortality (NRM) - Number of adverse events of special interest (AESI) — 1 year
Number of adverse events of special interest (AESI) - Assessment of the immunological homeostasis — 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 — 1 year
Incidence of the treatment-related dermatological events - Number of patients developing dose limiting toxicity (DLT) — first 28 days after infusion
Number of patients developing dose limiting toxicity (DLT)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Clínic | Barcelona | Spain | Recruiting |
| Hospital Sant Joan de Déu | Barcelona | Spain | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05679895 on ClinicalTrials.gov ↗ ← All trials in Spain