CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma

NCT07461831 | Active Not Recruiting Phase 2

• 2 other identifiers: TRhos-CART-022025ZD0544300
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.

Conditions

Large B-Cell Lymphoma (LBCL)

Keywords

CD19/CD22; bispecific; CAR-T; Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• best overall response rate (ORR) as of 3 months post-CAR-T cells infusion

  Overall response rate means sum of complete response rate and partial response rate

  From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion

Secondary Outcomes (4)

• Best Complete Response rate (CR) as of 3 months post-CAR-T cells infusion

  From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion

• Progression free survival (PFS)

  From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

• overall survival (OS)

  From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

Study Arms (1)

CD19/CD22 CAR-T group

EXPERIMENTAL

Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19/CD22 bispecific CAR-T cells was 2×10e6/kg.

Drug: CD19/CD22 bispecific CAR-T cells

Interventions

CD19/CD22 bispecific CAR-T cells DRUG

CD19/CD22-bispecific CAR-T cells were infused at the dosage of 2×10e6/kg

CD19/CD22 CAR-T group

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 85 years, expected survival \> 3 months;
• CD19 positive with or without CD22 positive Large B-cell lymphoma;
• relapsed or refractory disease;
• ECOG-PS score=0-2;
• Having at least one measurable lesion;
• Cardiac function: 1-2 levels;
• Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
• kidney: Cr≤1.25ULN;
• bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
• No serious allergic constitution;
• No other serious diseases that conflicts with the clinical program;
• No other cancer history;
• No serious mental disorder;
• Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

• Pregnant or lactating women (female participants of reproductive potential must have a negative serum or urine pregnancy test);
• Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
• Active hepatitis B or hepatitis C infection;
• With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
• Participate in other clinical research in the past 4 weeks;
• Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Study Officials

• Liang Wang, M.D.

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

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: Director of Department of Hematology

Model Details: In this group, all patients will receive CD19/CD22 bispecific CAR-T cell therapy.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: February 1, 2022
• Primary Completion: April 18, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)