CD19/CD22 CAR-T as First-line Consolidation in Follicular Lymphoma

NCT07587840 | Recruiting Phase 2 DMC

• 1 other identifier: 2026-196
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of CD19/CD22 Chimeric Antigen Receptor (CAR) T-Cell immunotherapy as first-line consolidation therapy in patients with follicular lymphoma.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 1-year progression free survival rate (1-year-PFSR)

  The 1-year progression-free survival rate (1-year PFSR) is defined as the proportion of patients who are alive and progression-free at 1 year after CAR-T cell infusion.

  2 year after treatment

Secondary Outcomes (7)

• overall survival (OS)

  2 years after treatment

• progression free survival (PFS)

  2 years after treatment

• disease free survival (DFS)

  2 years after treatment

• duration of response (DOR)

  2 years after treatment

• event free survival (EFS)

  2 years after treatment

Study Arms (1)

CD22/CD19 CAR-T cell immunotherapy

EXPERIMENTAL

patients with high-risk invasive Follicular Lymphoma who accept targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy

Biological: CD22/CD19 CAR-T cell immunotherapy

Interventions

CD22/CD19 CAR-T cell immunotherapy BIOLOGICAL

Autologous T cells were collected and genetically modified to express chimeric antigen receptors targeting CD19 and CD22. Following lymphodepleting chemotherapy, patients received a single intravenous infusion of CD19/CD22 CAR-T cells.

CD22/CD19 CAR-T cell immunotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. With the patient's consent and signed informed consent form, willing and able to comply with the planned visits, research treatments, laboratory tests, and other experimental procedures;
• \. CD19 and/or CD22-positive follicular lymphoma (FL) confirmed by histology according to the WHO classification:
• The patient's disease is still evaluated as partial response (PR) after induction treatment with standard first-line chemotherapy regimen, or
• The patient's disease reaches complete response (CR) after induction treatment with standard first-line chemotherapy regimen, but there are high-risk factors at the time of onset;
• \. The possible high-risk factors for the patient's onset of the disease are as follows: Presence of at least one of the following high-risk features at diagnosis:
• Follicular Lymphoma International Prognostic Index (FLIPI-1) score of 3-5 or FLIPI-2 score of 3-5;
• Presence of any lymph node or extranodal mass \>6 cm in diameter;
• Significant infiltration of CD68+ or CD163+ macrophages by immunohistochemistry;
• Gene sequencing revealing TP53 or NOTCH1 mutation;
• Presence of 1p36 deletion or 1q amplification;
• Next-generation sequencing (NGS)-defined high-risk mutation-based 7-gene Follicular Lymphoma International Prognostic Index (m7-FLIPI) subtype.
• \. Age range from 18 to 85 years old, male or female;
• \. Subjects with physical fitness status scores ranging from 0 to 2 in the Eastern Cooperative Oncology Group (ECOG) in the United States;
• \. Expected survival period from the date of signing the informed consent form is greater than 3 months;
• \. HGB ≥ 60g/L;

You may not qualify if:

• \. Have received any form of chimeric antigen receptor cell therapy or other genetically modified T cell therapy;
• \. Has a history of severe immediate hypersensitivity reactions to aminoglycoside antibiotics and other essential medications;
• \. Known history of human immunodeficiency virus (HIV) infection or active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as:
• HBV DNA quantification ≥ 2000 IU/ml;
• ALT ≥ 2 times the normal upper limit value;
• Exclude hepatitis caused by the disease itself, medication, or other reasons; All three conditions must be met simultaneously. If a patient is diagnosed with active HBV infection at the time of initial diagnosis and becomes non active HBV infection after anti HBV treatment, they can be included in this study under the premise of sufficient anti HBV treatment;
• \. Non hematological tumors (such as lymphoma) associated liver and kidney dysfunction: ALT\>3 times the upper limit of normal, AST\>3 times the upper limit of normal, TBIL\>2 times the upper limit of normal, serum creatinine clearance rate\<30 mL/min;
• \. History of myocardial infarction, cardiac angioplasty or coronary stent implantation, unstable angina, active arrhythmia, or other clinically significant cardiovascular diseases within the 12 months prior to enrollment;
• \. Other serious medical diseases may have an impact on this study (such as diabetes, gastric ulcer, other serious respiratory and circulatory diseases, severe autoimmune diseases or congenital immune defects, severe infection and inability to be effectively controlled), as well as other diseases with high risk of disease change;
• \. Has a history of severe immediate hypersensitivity reactions to any medication necessary for use in this study; History of severe allergy to biological products (including antibiotics);
• \. Female subjects who are currently pregnant or breastfeeding (with potential risks to the fetus or infant from pre-treatment chemotherapy regimens);
• \. The researchers determined that the subjects were unable to complete all the required visit surveys or diagnostic procedures (including medium - and long-term follow-up visits) as per the study protocol, had poor willingness to participate in the study, were unwilling to join and fully comply with the study arrangements, and had insufficient compliance with the study by the subjects and their families. The decision-making power belongs to the researcher;
• \. The subjects who have previously suffered from other malignant tumors cannot be included in this study unless they are disease-free and have not received any form of anti-tumor treatment for at least 3 years (except for skin tumors of non malignant melanoma and in situ cancers occurring in the cervix, bladder, breast, etc.);
• \. History of receiving live vaccines within 6 weeks prior to initiating the pre-treatment plan;
• \. Those who have undergone large-scale surgical treatment (excluding lymph node biopsy) within the past 14 days, or those who are expected to undergo large-scale surgical treatment during the treatment process;

Sponsors & Collaborators

• Liping Dou: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Li-Ping Dou Dr.

CONTACT

86-010-66937232; lipingruirui@163.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 INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)