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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Clínic
  Barcelona, Spain Recruiting
• Hospital Sant Joan de Déu
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Wilmar Castillo
• Email: wilmar@onechaintx.com
• Phone: 34 93 403 58 62

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

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• CD7 CAR T therapy for high-risk T-cell cancers

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  Recruiting Phase 1 Baylor College of Medicine · Houston, Texas and 1 other locations · NCT07220993

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.