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CD30.CAR EBVSTS alogénico almacenado almacenado con IL7R (C7R) constitutivo para linfomas positivos para CD30 (CABAL2)

30 de septiembre de 2026 actualizado por: Helen Heslop, Baylor College of Medicine

Linfocitos T específicos del virus de Epstein-Barr con receptor de antígeno quimérico CD30 alogénico almacenado constitutivo IL7R (C7R) (CD30.CAR-EBVST) en pacientes con linfomas CD30 positivos en recaída o refractarios

This study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.

Previous research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.

Another study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.

In this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.

As an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a Phase 1 dose-escalation study evaluating allogeneic C7R.CD30.CAR-EBVST cells in patients with relapsed or refractory CD30-positive lymphoma.

Participants are treated in sequential cohorts at one of four dose levels of C7R.CD30.CAR-EBVST cells. Treatment begins at the lowest dose level, and subsequent cohorts are treated at higher dose levels if the preceding dose is determined to be safe. If significant toxicity is observed, dose escalation may be halted, reduced, or discontinued. The relationship between dose level and both safety and potential clinical benefit is evaluated.

Prior to treatment, participants undergo screening evaluations including laboratory testing, imaging studies, and confirmation of CD30 expression. Human leukocyte antigen (HLA) testing is performed to identify the most appropriate partially matched cell line from a bank of allogeneic C7R.CD30.CAR-EBVST products.

Participants may receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to infusion, as clinically appropriate, to reduce endogenous lymphocytes and support expansion of the infused cells.

C7R.CD30.CAR-EBVST cells are administered as a single intravenous infusion at the assigned dose level. Premedication may be given to reduce the risk of infusion-related reactions. Participants are monitored in the clinical setting following infusion and are required to remain within close proximity to the treatment center for a defined period to allow for monitoring of potential adverse events.

Following treatment, participants undergo scheduled follow-up evaluations including physical examinations, laboratory testing, and imaging studies to assess safety and disease status. Blood samples are collected at multiple time points after infusion to evaluate persistence of the infused cells. Tumor assessments are performed using imaging and, when clinically indicated, biopsy.

Participants demonstrating an objective clinical response following initial dosing may be considered for up to three (3) additional infusions of C7R.CD30.CAR-EBVST cells, at the discretion of the treating clinical team.

Participants are followed longitudinally after treatment, with more frequent assessments early after infusion and less frequent long-term follow-up, for up to 15 years after the most recent infusion.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Texas
      • Houston, Texas, Estados Unidos, 77030
      • Houston, Texas, Estados Unidos, 77030
        • Aún no reclutando
        • Texas Children's Hospital
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 75 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Diagnosis and clinical course falling into one of the following categories:

    1. Hodgkin lymphoma
    2. CD30+ aggressive B-cell lymphoma
    3. ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma
    4. ALK-positive anaplastic T cell lymphoma

  2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.

  3. Age 12 to 75.

  4. Bilirubin less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).

  5. AST less than 3 times the upper limit of normal.

  6. Estimated GFR > 70 mL/min.

  7. Pulse oximetry of > 90% on room air

  8. Karnofsky or Lansky score of > 60%.

  9. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.

  10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.

  11. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.

Exclusion Criteria:

  1. Received an investigational cell therapy or vaccine within the past 6 weeks.
  2. Received an investigational small molecule drug within the past 2 weeks.
  3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.
  4. History of hypersensitivity reactions to murine protein-containing products.
  5. Pregnant or lactating.
  6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
  7. Current use of systemic corticosteroids at a dose equivalent to or higher than 10 mg/day of prednisone.
  8. Active significant, uncontrolled bacterial, viral or fungal infection.
  9. Symptomatic cardiac disease (NYHA Class III or IV disease).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment Phase

Four dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells.

Cohorts of three patients will be enrolled at each dose level The dose is based on the number of CD.30 CAR-EBVT-expressing cells administered.

The total number of dose levels evaluated will depend upon toxicities experienced. Dose level cohorts will be numbered sequentially.

  • Dose Level 1: 4 × 10^7 C7R.CD30.CAR-EBVST cells
  • Dose Level 2: 1 × 10^8 C7R.CD30.CAR-EBVST cells
  • Dose Level 3: 4 × 10^8 C7R.CD30.CAR-EBVST cells
  • Dose Level 4: 8 × 10^8 C7R.CD30.CAR-EBVST cells
Biológico: C7R.CD30.CAR-EBVST cells

The dose is based on the number of CD30.CAR- expressing cells. In our previous study the highest dose was 4 × 10^8 cells/m2 and we did not reach an MTD. On Day 0, patients will receive their planned dose of investigational T cell product by IV infusion over approximately 1 to 10 minutes in an expected volume of 1 to 50 mL.

Otros nombres:
  • Linfocitos T específicos del virus de Epstein-Barr del receptor de antígeno quimérico CR7.CD30 alogénico

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dose Limiting Toxicity (DLT)
Periodo de tiempo: 28 days

Dose-limiting toxicity (DLT) is defined as any of the following considered possibly, probably, or definitely related to study cellular products: (1) Grade 5 event without disease progression; (2) CRS: Grade 4, or Grade 3 not improving to ≤Grade 2 within 72 hours despite therapy; (3) ICANS: Grade 4, or Grade 3 not improving within 72 hours despite therapy; (4) Grade ≥3 IEC-HS; (5) Grade ≥3 acute GvHD requiring corticosteroids and not resolving within 7 days, or steroid-refractory Grade 2 GvHD; (6) Grade 4 neutropenia or thrombocytopenia not resolving to ≤Grade 2 within 42 days, or Grade 3 thrombocytopenia with major bleeding; (7) Grade ≥3 vital organ toxicity (except transient hepatic/renal abnormalities resolving within 7 days); (8) other Grade 3 toxicities not resolving within 72 hours; (9) Grade ≥2 allergic reaction.
28 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of Anti-Tumor effect Objective Response (OR)
Periodo de tiempo: 6 to 8 weeks post CTL infusion

Objective response rate is defined as complete response and partial response
6 to 8 weeks post CTL infusion
Duration of response
Periodo de tiempo: Up to 5 years

Response duration will be measured from the time of initial response until documented tumor progression.
Up to 5 years
Stable disease (SD) rate
Periodo de tiempo: 6 to 8 weeks post CTL infusion

SD will be defined as the proportion of patients that have stable disease
6 to 8 weeks post CTL infusion
Duration of SD
Periodo de tiempo: Up to 5 years

Stable disease is measured from the start of the treatment until the criteria for progression are met.
Up to 5 years
Progression free survival (PFS)
Periodo de tiempo: Up to 5 years

PFS is defined as the time from treatment until objective tumor progression or death, whichever occurs first.
Up to 5 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Baylor College of Medicine

Colaboradores

The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine

Investigadores

  • Investigador principal: Helen Heslop, MD, Baylor College of Medicine
  • Investigador principal: Premal Lulla, MD, The Methodist Hospital Research Institute

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de octubre de 2025

Finalización primaria (Estimado)

27 de julio de 2028

Finalización del estudio (Estimado)

27 de junio de 2043

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

11 de diciembre de 2023

Publicado por primera vez (Actual)

20 de diciembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • H-56523, CABAL2

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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