A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 75
Healthy Volunteers: f
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• Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.

• All of the following conditions must be met:

∙ Age 2-75 years at informed consent; both sexes eligible. For minors (≤18 years), consent must be provided by a parent/legal guardian; minors able to sign must co-sign with their guardian.

‣ Histologically confirmed B-cell lymphoma per the 2024 v3 NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas.

‣ Prior therapy requirements:

• Failure to achieve PR after first-line therapy, OR relapse within 12 months after first-line therapy; or Relapsed/refractory after second-line therapy (one standard chemo-regimen + one salvage regimen).

• Prior regimens must have included anti-CD20 monoclonal antibody (unless documented CD20-negative tumor) and an anthracycline-containing regimen. In addition, at least one of the following must apply:

• 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 PR or CR.

• • Refractory: i. PD during/after last therapy, or best response ≤SD lasting \<6 months; OR ii. Relapse or progression after ASCT (biopsy-proven), including relapse/PD ≤12 months post-ASCT or lack of response (SD/PD) to salvage therapy after ASCT.

• Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.

• ≥1 measurable lesion per Lugano 2014 response criteria.

• ECOG performance status 0-3.

• Adequate marrow reserve: ALC ≥0.3 × 10⁹/L; PLT ≥30 × 10⁹/L (transfusion permitted).

• Adequate organ function:

• • AST ≤3×ULN (≤5×ULN if tumor-related); ALT ≤3×ULN (≤5×ULN if tumor-related);• Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome);• Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault);• Pulmonary: ≤Grade 1 dyspnea and SpO₂ \>91 % on room air;• LVEF ≥50 % by echocardiography;• INR ≤1.5×ULN and APTT ≤1.5×ULN.

• Women of child-bearing potential: negative serum/urine pregnancy test within 7 days before CAR-T infusion. All participants with reproductive potential must use effective contraception from screening through ≥12 months after CAR-T infusion.

• Adequate venous access for leukapheresis or repeated phlebotomy, with no contraindications to leukapheresis.

⁃ Estimated life expectancy \>3 months.

Locations
Other Locations
China
Hebei Yanda Lu Daopei Hospital
RECRUITING
Hebei
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Tianjin First Central Hospital
RECRUITING
Tianjin
Contact Information
Primary
Wenjun Zhang, Ph.D
zhangwenjun@tongji.edu.cn
13918803148
Backup
Junfang Yang
Yangjunfang77@163.com
13522084342
Time Frame
Start Date: 2025-01-23
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 30
Treatments
Experimental: U01(ssCART-19) CAR-T cells
CD19-targeted CAR-T cells engineered with an IL-6 silencing element
Related Therapeutic Areas
Sponsors
Leads: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

This content was sourced from clinicaltrials.gov

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