OncoMatch/Clinical Trials/NCT05679895
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
Is NCT05679895 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD1a-CAR T for t-cell acute lymphoblastic leukemia.
Treatment: CD1a-CAR T — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD1A antigen blast expression ≥20% (≥20%)
Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.
Prior therapy
Must have received: chemotherapy — at least two cycles
Failure to achieve morphological complete remission (> 5% bone marrow blasts) or persistence of extramedullary disease after at least two cycles of chemotherapy.
Must have received: standard frontline therapy — at least one
First or subsequent relapse, including morphologic or MRD-detectable (≥1x10-4 ) bone marrow and/or extramedullary relapses after at least one standard frontline therapy.
Must have received: allogeneic stem cell transplant — relapse after allo-HSCT
Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT).
Cannot have received: allogeneic stem cell transplant
Exception: allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD)
Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).
Cannot have received: experimental drug
The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
Lab requirements
Kidney function
No uncontrolled renal dysfunction
Liver function
No uncontrolled liver dysfunction
Cardiac function
No uncontrolled cardiac dysfunction (e.g., depressed LVEF <45%)
Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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