Clinical Study of Multi-targeted CAR-T Therapy in Patients With Relapsed/Refractory B-Cell Lymphoma

NCT07093086 | Withdrawn Phase 1

• 1 other identifier: U05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma.

Conditions

B-cell Lymphoma

Keywords

CAR-T; CD19; CD22; CD20

Outcome Measures

Primary Outcomes (5)

• Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability]

  An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  28 days post administration of CAR-T-cells

• Objective Response Rate (ORR), as assessed by Investigators

  The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission (PR)

  2 years post CAR T cell infusion

• Duration of response (DOR), as assessed by Investigators

  Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.

  2 years post CAR T cell infusion

• Progression-free survival (PFS), as assessed by Investigators

  Progression-free survival (PFS) was defined as the time from the date of infusion to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

  2 years post CAR T cell infusion

• Overall survival (OS)

  Overall Survival (OS) was defined as the time from the date of first infusion to the date of death due to any cause.

  2 years post CAR T cell infusion

Secondary Outcomes (4)

• Pharmacokinetics of CAR-T cells

  2 years post CAR T cell infusion

• Pharmacokinetics of CAR-T cells

  2 years post CAR T cell infusion

• Pharmacokinetics of CAR-T cells

  2 years post CAR T cell infusion

• Pharmacodynamics of CAR-T cells

  2 years post CAR T cell infusion

Study Arms (1)

Multi-targeted CAR-T Therapy

EXPERIMENTAL

Patients will receive a regimen combining CD19/CD22 dual-targeted CAR-T cells with CD19/CD20 dual-targeted CAR-T cells; investigators may administer them sequentially according to each patient's condition.

Drug: Triple-targeted CAR-T Therapy

Interventions

Triple-targeted CAR-T Therapy DRUG

Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.

Multi-targeted CAR-T Therapy

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent obtained from the participant (or legally authorized representative) with good compliance expected throughout the study.
• All of the following must be fulfilled:
• Age 2-75 years at the time of informed consent; both sexes eligible.For minors (≤18 years), consent must be provided by a parent or legal guardian; minors who are able to sign must co-sign with their guardian.
• Histologically confirmed B-cell lymphoma according to the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (2024 v3).
• Relapsed or refractory B-cell lymphoma after at least two prior lines of therapy (one standard chemo-regimen + one salvage regimen) that must have included:
• anti-CD20 monoclonal antibody (except for subjects with documented CD20-negative tumors), and
• an anthracycline-containing regimen.
• Subjects must additionally meet at least one of the following:
• i. Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); ii. Refusal of ASCT; iii. Relapse after ASCT. d) Disease status at screening:
• Relapse: progression after prior response (PR or CR).
• Refractory: i. No response to last therapy (progressive disease \[PD\] during/after, or best response ≤SD lasting \<6 months); OR ii. Relapse or progression after ASCT (biopsy-proven) including: relapse/PD ≤12 months post-ASCT, or relapse/PD after salvage therapy post-ASCT without response (SD or PD).
• Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry (pathology report within 6 months preferred).
• ≥1 measurable lesion per Lugano 2014 (Cheson) criteria.
• ECOG performance status 0-3.
• Adequate marrow reserve at screening:Absolute lymphocyte count (ALC) ≥0.3 × 10⁹/L; Platelets ≥30 × 10⁹/L (transfusion permitted).

You may not qualify if:

• Concurrent malignancy other than the study indication. Exceptions: carcinoma in situ or any malignancy with disease-free survival ≥3 years.
• Use of immunosuppressive agents or systemic corticosteroids within 1 week before leukapheresis that, in the investigator's judgment, could substantially impair T-cell function.
• Presence of any of the following:• Positive HBe-Ab and/or HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.
• Active bacterial, fungal, viral, mycoplasmal, or other infection that, in the investigator's opinion, cannot be adequately controlled.
• Prior or current CNS disorders unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-deemed uncontrolled by the investigator.
• Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), or NYHA Class III-IV congestive heart failure, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease judged by the investigator. QTc interval \>480 ms (Fridericia correction), or left-ventricular ejection fraction \<50 % by echocardiography at screening.
• Known primary immunodeficiency.
• History of severe immediate hypersensitivity to any study-related drug.
• Receipt of any live vaccine within 6 weeks before screening.
• Pregnant or breastfeeding women.
• Active autoimmune disease requiring systemic immunosuppressive therapy.
• Participation in any other interventional clinical trial within 30 days before signing informed consent.
• Any condition that, in the investigator's opinion, renders the subject unsuitable for study participation.

Sponsors & Collaborators

• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: lead

Study Sites (2)

Hebei Yanda Ludaopei Hospital

Hebei, China

Location

Tongji Hospital of Tongji University

Shanghai, China

Location

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

Study Officials

• Junfang Yang, Ph.D.

  Hebei Yanda Ludaopei Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: November 7, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-07

Locations

CN (2)