Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma

NCT07508605 | Recruiting Phase 1

• 1 other identifier: 113
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Title:
2. 2.Study Objectives:
3. 3.Participant Intervention:

Conditions

Relapsed/Refractory B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• TEAEs

  Adverse events during treatment

  From date of initial treatment to the 30 days after treatment

Secondary Outcomes (1)

• Disease-related clinical responses

  From date of enrollment until the date of clinical responses,up to 2 years

Study Arms (1)

CAR/TRuC-T

EXPERIMENTAL

Combination Product: CAR/TRuC-T

Interventions

CAR/TRuC-T COMBINATION_PRODUCT

Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

CAR/TRuC-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:

• Subjects must meet all of the following criteria to be enrolled:
• Aged 18 to 75 years, regardless of sex;
• Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;
• ECOG performance status of 0-2;
• Expected survival of at least 3 months;
• CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
• Patients who are resistant/refractory to CD19 CAR-T cell therapy or have low CD19 expression;
• No severe cardiac, pulmonary, hepatic, or renal disease;
• Able to understand and willing to sign the informed consent form for this study;
• No contraindications to peripheral blood mononuclear cell collection/apheresis;
• At least one measurable and evaluable lesion according to RECIST 1.1;
• Must have previously received standard first-line and second-line therapy;

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded:
• History of allergy to any component of the cell product;
• Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹/L, ANC ≤0.5 × 10⁹/L, ALC ≤0.5 × 10⁹/L, or PLT ≤25 × 10⁹/L;
• Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg/dL; ALT or AST \>2.5 times the upper limit of normal; serum creatinine ≥2.0 mg/dL;
• New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \<50% on echocardiography;
• Abnormal pulmonary function, with oxygen saturation \<92% on room air;
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
• Grade 3 hypertension with poor blood pressure control despite medication;
• History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
• Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
• Presence of uncontrolled active infection;
• Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
• Receipt of a live vaccine within 4 weeks prior to enrollment;
• Positive for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status;
• History of alcohol abuse, drug abuse, or psychiatric illness;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, Guangdong, 518055, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

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

LIXIN LI, PHD

CONTACT

0755-21839999; wanglixin1991@sohu.com

Study Design

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

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)