Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma

NCT07254754 | Recruiting Phase 2

• 1 other identifier: LATE-R-GEL-23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 15

Brief Summary

Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years. The total duration of the study is therefore of 7 years.

Conditions

DIFFUSE LARGE B-CELL LYMPHOMA

Keywords

lymphoma; axicabtagene; geltamo; DIFFUSE LARGE B-CELL LYMPHOMA; DLBCL; RELAPSE

Outcome Measures

Primary Outcomes (1)

• Response month 3

  The Complete Metabolic Response, defined as negative findings on a PET/CT scan at month 3 after receiving axicabtagene ciloleucel infusion at day 0. The negativity of PET/CT findings will be assessed according to Lugano Classification and Deauville criteria

  Month 3

Secondary Outcomes (14)

• Response month 3 central

  Month 3

• Overall response rate

  Month 3

• Best objective response

  1 year

• Best complete response rate

  1 year

• Overall survival

  Up to 5 years

Other Outcomes (6)

• Total Metabolic Tumor

  Up to 2 years

• Phenotypic expression of lineage and checkpoint markers in tumor

  Up to 2 years

• Cytokine levels

  Up to week 4

Study Arms (1)

Axicabtagene ciloleucel

EXPERIMENTAL

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 10E6 - 2 × 10E6 cells/kg), with a maximum of 2 × 10E8 CAR-positive viable T cells for patients 100 kg and above.

Drug: Axicabtagene Ciloleucel

Interventions

Axicabtagene Ciloleucel DRUG

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 106 - 2 × 106 cells/kg), with a maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and above.

Axicabtagene ciloleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written Informed Consent Form
• Age \> 18 years
• Patient who understands and speaks one of the country official languages
• Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL) and follicular lymphoma Grade 3B per WHO 2016 classification. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with R-CHOP-like after transformation are eligible. Primary mediastinal B-cell lymphoma are not eligible.
• Positron-emission tomography (PET)-positive disease
• Patients must have received adequate first-line therapy including at a minimum:
• An anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and
• CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to ACVBP, EPOCH, or COPADEM. Dose-reduced CHOP (i.e., miniCHOP) is excluded except for dose-reductions of vincristine due to peripheral neuropathy. Patients who have received additional drugs in combination with CHOP or CHOP-like regimen are eligible.
• Relapsed disease after first line chemo immunotherapy (full dose of R-CHOP or R-CHOP-like regimen), documented by PET-scan and biopsy:
• Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse after 12 months and up to 5 years from end of first-line therapy.
• Patients must meet CAR-T-eligible criteria as defined by:
• Patient deemed eligible for CAR T-cells therapy by the CAR-T physician
• AND all the following criteria:
• ECOG performance status of 0, 1 or 2
• Adequate vascular access for leukapheresis procedure (either peripheral or central venous line)

You may not qualify if:

• Patients who received more than one prior line of systemic therapy
• Early relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse before 12 months from end of first-line therapy.
• Refractory disease defined as:
• Progressive disease (PD) during first-line therapy
• Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
• Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
• Patients who received first line of R-CHOP or obinutuzumab-CHOP for an indolent B-NHL who relapse as transformed aggressive B-NHL after a year from the end of first-line therapy are NOT eligible.
• Prior CD19 targeted therapy
• Patients with cardiac atrial or cardiac ventricular lymphoma involvement
• Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or blood vessel compression
• Patient with clinically significant pleural effusion
• History of another primary malignancy that has not been in remission for at least 3 years (except for nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast)). A maintenance treatment is not allowed.
• Patients with detectable Central Nervous System (CNS) lymphoma. Patients with a history of CNS lymphoma but no active CNS disease (after systematic MRI and lumbar puncture) at the time of enrolment will be eligible.
• Presence of CNS disorder such as dementia, autoimmune disease with CNS involvement, cerebral edema with confirmed structural defects by appropriate imaging, or seizure disorders requiring active anticonvulsive medication. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrolment.
• Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted.

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: lead
• Kite, A Gilead Company: collaborator
• Evidenze Health España (CRO): collaborator

Study Sites (15)

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15008, Spain

RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 7120, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Institut Català d'oncologia de L'Hospitalet

L'Hospitalet de Llobregat, Catalonia, 08908, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, Spain

RECRUITING

Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Murcia, 30008, Spain

RECRUITING

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Related Links

• GELTAMO web page

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma; Recurrence

Interventions

axicabtagene ciloleucel

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariana Bastos-Oreiro

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• Alejandro Martín García-Sancho

  Hospital Universitario Salamanca

  PRINCIPAL INVESTIGATOR

• Armando López-Guillermo

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Auxi Moreno

CONTACT

+34 683636850; amoreno@geltamo.com

Ana María Méndez

CONTACT

administracion@geltamo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: November 28, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (15)