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

NCT ID: NCT06365671

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2027-04-30

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

Detailed Description

This is a single-center, single-arm, open-label, prospective clinical trial to evaluate the efficacy and safety of CD19 CAR-T infusion following high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT) in relapsed or refractory B-cell Non-Hodgkin's Lymphoma patients with high-risk prognostic factors (extranodal involvement/bulky mass ≥5 cm in diameter/TP53 alterations). CD19 CAR-T will be infused on day +3 (±1d) with a fixed dose of 100X10^6. The study will assess the safety and efficacy of this combinational therapy, including the investigators assessed the best complete response rate (BCR) in 3 months (primary endpoint), objective response rates, survivals, incidence and severity of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological, and other non-hematological toxicities of the subjects.

Conditions

B-cell Non Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T following ASCT

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

Group Type: EXPERIMENTAL

autologous stem-cell transplantation

Intervention Type: OTHER

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

Relmacabtagene autoleucel (relma-cel)

Intervention Type: DRUG

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

Interventions

autologous stem-cell transplantation

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

Intervention Type: OTHER

Relmacabtagene autoleucel (relma-cel)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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)

2. 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

3. 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

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

5. Eligible for HDCT/ASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen

6. Adequate renal and hepatic function defined as:

• Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN)
• Total bilirubin ≤1.5 mg/dL(<3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma)
• Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min

7. Cardiac ejection fraction ≥ 40%

8. Baseline oxygen saturation > 95% on room air

9. Life expectancy ≥3 months

Exclusion Criteria

1. History of autologous or allogeneic stem cell transplantation

2. 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.

3. Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.

4. History of HIV infection

5. Prior chimeric antigen receptor cellular immunotherapy targeting CD19

6. Pregnant or lactating patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Weili Zhao

Role: CONTACT

zwl_trial@163.com

+862164370045

Li Wang

Role: CONTACT

+862164370045

Facility Contacts

Weili Zhao

Role: primary

zwl_trial@163.com

Other Identifiers

ASCT-CART

Identifier Type: -

Identifier Source: org_study_id