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 (Jun 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
Treatments studied
Other
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.
Demographics
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.
Frequently asked questions
Is NCT05679895 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplant, experimental drug disqualifies patients from enrollment.
Does this trial require CD1A?
Yes, CD1A antigen blast expression ≥20% is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify