Exploratory Clinical Study of CD19-targeted CAR-T and CAR-DC in the Treatment of Relapsed and Refractory B-cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an open, single-arm, prospective, dose-escalation clinical trial designed to evaluate the safety and the preliminary efficacy of CD19-targeted CAR-T combined with CAR-DC in the treatment of relapsed and refractory B-cell lymphoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Male or female participants aged 18 to 75 years old at the time enrollment, with ECOG Score of ≤ 3;

• Patients should provide a written informed consent;

• Histologically confirmed CD19+ DLBCL, HGBL-DHL, MCL, tFL, PMBL;

‣ Confirmation obtained from central pathology review before enrollment;

⁃ Sufficient formalin-fixed, paraffin-embedded tumor samples were required for histologically confirmed diagnosis and detection of CD19 expression;

⁃ Relapsed DLBCL and tFL after ≥2 lines of chemotherapy that include rituximab and anthracycline, or refractory disease as defined in the SCHOLAR-1 study: progressive disease after receiving ≥ 4 cycles of first-line therapy or stable disease (received 2 cycles of later-line therapy) as best response to chemotherapy or relapse ≤ 12 months after autologous stem cell transplantation (ASCT);

⁃ Relapsed/refractory MCL after ≥ 2 lines of prior therapy, including immunochemotheapy and BTK inhibitor such as ibrutinib, or patient did not agree to receive BTK inhibitor treatment;

⁃ At least one measurable tumor according to revised International Working Group (IWG) Response criteria;

• Life expectancy ≥ 3 months;

• Adequate cardiac, pulmonary, liver, renal, and bone marrow functions, with the following laboratory values: an absolute neutrophil count \> 1,000/mm3, platelets count ≥ 45,000/mm3, and hemoglobin \> 8.0g/dl; alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × the upper limit of the normal range (ULN), and total bilirubin ≤ 2.0 mg/dl; a serum creatinine of ≤ 1.5 × ULN; a left ventricular ejection fraction ≥ 50%;

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hanzhou
Contact Information
Primary
Wenbin Qian, PhD
qianwb@zju.edu.cn
13605801032
Backup
Wen Lei, PhD
leiwen2017@zju.edu.cn
18258448016
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 70
Treatments
Experimental: Combination therapy of CD19 CAR-T and CD19 CAR-DC
6-18 patientsare planned to be enrolled in the dose-escalation trial (0.5×10\^6/kg、1×10\^6/kg、2×10\^6/kg和4×10\^6/kg) and 52 patients in the dose-expansion trial.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov