Exploratory Clinical Study on the Safety and Efficacy of CD19X CAR-T Cell Injection in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma

NCT07447726 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IIT2025136
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion.

Conditions

Large B-Cell Lymphoma (LBCL)

Keywords

relapsed/refractory

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Evaluate the possible adverse reactions recorded after CAR-T infusion, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, and hematologic toxicities.

  Within 28 days after CAR-T infusion

Secondary Outcomes (6)

• Efficacy indicators

  At 1 and 3 months after CAR-T infusion

• Efficacy indicators

  At 1 and 3 months after CAR-T infusion

• Cell Metabolic Kinetics Indicators

  On the 7th, 10th, 14th, and 28th days after treatment

• Cellular Metabolic Kinetics Indicators

  On the 7th, 10th, 14th, and 28th days after treatment

• Cellular Metabolic Kinetics Indicators

  Day 28 after treatment

Study Arms (1)

CD19X CAR-T

OTHER

Drug: CD19X CAR-T

Interventions

CD19X CAR-T DRUG

Eligible participants receive lymphodepletion pretreatment 3 to 5 days before the therapy. The recommended pretreatment regimen is fludarabine (25-30 mg/m²) and cyclophosphamide (250-300 mg/m²). Antihistamines are administered before infusion. The plan is to enroll 3 patients with relapsed/refractory large B-cell lymphoma, who will be evaluated by the investigator and treated with 1-2 × 10\^6 CAR cells/kg of CAR-T cell infusion.

CD19X CAR-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The participant has given consent and signed the informed consent form, and is willing and able to comply with planned visits, research treatments, laboratory tests, and other trial procedures;
• \. Clinically diagnosed with relapsed/refractory large B-cell lymphoma, and confirmed by pathology or flow cytometry that tumor cells express CD19, including: diffuse large B-cell lymphoma (DLBCL), transformed indolent B-cell lymphoma to DLBCL (excluding Richter transformation), and meeting the following criteria (satisfying one of the first two and the third): i. Relapse ≥6 months after achieving remission following first-line adequate therapy or ≥12 months after stem cell transplantation; ii. Patients who did not achieve remission after at least 2-4 cycles of first-line chemotherapy combined with high-risk factors (double-expressor lymphoma, double-hit lymphoma, TP53 gene mutation or deletion, IPI score ≥3), or disease progression during first-line therapy, or progression within 6 months after achieving remission from prior sufficient therapy, or relapse within 12 months after achieving remission from stem cell transplantation; iii. The participant has received the following treatments for LBCL after diagnosis:
• Anti-CD20 monoclonal antibody;
• Combination chemotherapy containing anthracyclines.
• \. Age 18 years and above, both male and female;
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• \. Expected survival of more than 3 months from the date of signing the informed consent form;
• \. HGB ≥ 60 g/L (blood transfusion allowed); LYM ≥ 0.3\*10\^9/L;
• \. Liver and kidney function, as well as cardiopulmonary function, must meet the following requirements:
• Creatinine ≤ 1.5×ULN;
• Left ventricular ejection fraction ≥ 50%;
• Blood oxygen saturation \> 90%;
• Total bilirubin ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN;
• \. Study participants planning pregnancy must agree to use contraception before enrollment in the study and for one year after CAR-T cell infusion; participants should notify the investigator immediately if they become pregnant or suspect they are pregnant.

You may not qualify if:

• \. Severe heart failure with left ventricular ejection fraction \<50%;
• \. History of severe pulmonary dysfunction;
• \. Concurrent progressive malignant tumors;
• \. Severe infections that cannot be effectively controlled;
• \. Severe autoimmune diseases or congenital immunodeficiency;
• \. History of CAR-T cell immunotherapy;
• \. Active hepatitis (hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] levels above the detection limit);
• \. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
• \. History of severe allergic reactions to biological products (including antibiotics);
• \. Allogeneic hematopoietic stem cell transplant patients who still have acute graft-versus-host disease (GvHD) one month after discontinuing immunosuppressive drugs.
• \. Women who are pregnant or breastfeeding, or planning to become pregnant within 12 months;
• \. Individuals with other serious physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study, interfere with the study results, or whom the researcher considers unsuitable for participation in this study.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liang Huang

CONTACT

02223608359; huangliang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: March 3, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE