CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

NCT06365671 | Recruiting Phase 2

• 1 other identifier: ASCT-CART
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors

Conditions

B-cell Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Best Complete Response (CR) Rate in 3 months

  Best Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators.

  3months post CAR-T infusion

Secondary Outcomes (5)

• Objective remission rate (ORR) in 3months

  3months post CAR-T infusion

• Duration of Response (DOR)

  2 years post CAR-T infusion

• Progression-Free Survival (PFS)

  2 years post CAR-T infusion

• Overall Survival (OS)

  2 years post CAR-T infusion

• Adverse Events rate as assessed by CTCAE version 5.0

  2 years post CAR-T infusion

Study Arms (1)

CAR-T following ASCT

EXPERIMENTAL

Participants will receive high-dose chemotherapy followed by stem-cell infusion, and a fixed dose of CAR-T cells will be infused.

Other: autologous stem-cell transplantation; Drug: Relmacabtagene autoleucel (relma-cel)

Interventions

autologous stem-cell transplantation OTHER

high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT)

CAR-T following ASCT

Relmacabtagene autoleucel (relma-cel) DRUG

relma-cel (CD19 CAR-T cell)infusion on day 3(±1d) after ASCT with a fixed dose of 100X10\^6.

CAR-T following ASCT

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types
• diffuse large B-cell lymphoma
• high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement
• transformed lymphoma
• primary mediastinal large B-cell lymphoma
• follicular lymphoma (FL)
• Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)
• Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy
• Stable disease (SD) as best response after at least 4 cycles of first-line therapy
• Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)
• PR as best response after at least 2 cycles of second-line therapy
• Disease relapse ≤12 months after the completion of first-line immunochemotherapy
• Relapsed or refractory disease after ≥2 lines of chemotherapy
• Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

You may not qualify if:

• History of autologous or allogeneic stem cell transplantation
• Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion.
• Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
• History of HIV infection
• Prior chimeric antigen receptor cellular immunotherapy targeting CD19
• Pregnant or lactating patients

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

relmacabtagene autoleucel

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Li Wang

CONTACT

+862164370045

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: April 16, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (1)