Evaluating OC-1 Therapy for Patients with Relapsed T-Cell Leukemia and Lymphoma

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

This study is testing a new therapy for children and adults with relapsed T-cell leukemia and lymphoma to see if it can help them feel better after other treatments have failed.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: OneChain Immunotherapeutics (Industry-sponsored)
• Drugs / interventions: chemotherapy, CAR T
• Locations: 2 sites (Barcelona and 1 other locations)
• Trial ID: NCT05679895 on ClinicalTrials.gov

What this trial studies

This clinical trial is an exploratory, open-label, single-arm, multicenter study designed to assess the safety and efficacy of CD1a-CAR T therapy in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LL). It involves a dose escalation approach to determine the optimal therapeutic dose while monitoring for adverse effects. The study aims to enroll both children and adults who express the CD1a antigen and have experienced multiple relapses after standard therapies.

Who should consider this trial

Good fit: Ideal candidates include children over 2 years and adults with CD1a-positive T-ALL or LL who have relapsed after at least two lines of therapy.

Not a fit: Patients with significant organ dysfunction or those who do not express the CD1a antigen may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat relapsed or refractory T-ALL and LL.

How similar studies have performed: Other studies utilizing CAR-T therapies have shown promising results, indicating potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Barcelona and 1 other locations

• Hospital Clínic — Barcelona, Spain (Recruiting)
• Hospital Sant Joan de Déu — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Wilmar Castillo

Conditions T-cell Acute Lymphoblastic Leukemia; Lymphoblastic T-Cell Lymphoma; CAR-T-based therapies; CD1a