BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 36 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
Leer la descripción completa
This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Non-Hodgkin's Lymphoma (B-NHL) that has come back (recurrent) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize BAFFR, a protein on the surface of cancer cells. These BAFFR-specific T cells may help the body's immune system identify and kill BAFFR+ cancer cells.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Informed Consent: Signed informed consent by the participant or legally authorized representative.
2. Age \& Performance Status:
* Age ≥ 18 years
* ECOG performance status ≤ 2
3. Diagnosis \& Disease Criteria:
* Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions.
* BAFF-R expression on lymphoma cells required.
4. Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
5. Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence \< 5% before leukapheresis.
6. Organ Function \& Laboratory Criteria:
* Hematologic: ANC ≥ 1000/μL, Platelets ≥ 75,000/μL (exceptions for BM involvement).
* Liver Function: Bilirubin ≤ 1.5x ULN (except Gilbert's), AST/ALT \< 3x ULN.
* Renal Function: CrCl ≥ 50 mL/min.
* Cardiac \& Pulmonary: LVEF ≥ 45%, QTcF ≤ 480 ms, O₂ saturation \> 91% on room air.
7. Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).
8. Reproductive Considerations:
- Negative pregnancy test for females of childbearing potential.
- Use of effective contraception or abstinence through 3 months post-treatment.
Exclusion Criteria:
1. Prior Therapies \& Transplants:
* Prior allogeneic SCT.
* Autologous SCT \< 6 months before leukapheresis.
* Concurrent systemic steroids or chronic immunosuppressant use.
2. Disease-Specific Exclusions:
* Cardiac lymphoma involvement.
* Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).
3. Medical Conditions:
* Active autoimmune disease requiring immunosuppressants.
* Primary immunodeficiency.
* Cardiac conditions, including NYHA Class III/IV heart disease, arrhythmia, recent MI (≤ 6 months), stroke (≤ 6 months), or significant VTE (≤ 6 months).
* Neurologic conditions, including prior optic neuritis, CNS inflammatory diseases, or seizure disorders.
* History of malignancy, unless resected/treated with curative intent or in remission for ≥ 3 years.
* Uncontrolled systemic infections or active CNS lymphoma.
4. Pregnancy \& Breastfeeding: Females who are pregnant or nursing.
5. Other Considerations:
- Investigator-determined safety concerns.
- Potential noncompliance with study procedures.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells]
BAFFR-CAR T cells in participants with r/r B-NHL
Biological: BAFFR-CAR T cells
BAFFR-CAR T cells BIOLOGICAL
First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Incidence of adverse events
Plazo: Up to 1 year post treatment
Assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B-cell Non-Hodgkin's Lymphoma (B-NHL) and it's subtypes. Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.
Maximum Tolerated Dose (MTD)
Plazo: The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.
Determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BAFFR-CAR T cells. The highest dose with ≤ 1/6 participants with DLT will be considered the MTD.
Medidas secundarias
Disease Response
Plazo: Up to 1 year post treatment
Defined as achieving a best response of complete response or partial response per Lugano Criteria
B Cell Quantification
Plazo: Up to 1 year post treatment
Measured by flow cytometry
Progression-free survival (PFS)
Plazo: From CAR T cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate PFS.
Overall Survival (OS)
Plazo: From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate OS.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (5)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
5 centros
City of Hope Medical CenterDuarte, California, United StatesReclutando
Stanford UniversityStanford, California, United StatesReclutando
University of Kansas HospitalKansas City, Kansas, United StatesReclutando
University of MinnesotaMinneapolis, Minnesota, United StatesReclutando
Providence Swedish Cancer InstituteSeattle, Washington, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- PeproMene Bio, Inc.
- Inicio del estudio
- 13 jun 2022 Real
- Finalización primaria
- 13 jul 2027 Estimado
- Finalización del estudio
- 13 jun 2028 Estimado
- Primera publicación
- 11 may 2022 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026