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Trial Title:
Exploratory Clinical Study of CD19-targeted CAR-T and CAR-DC in the Treatment of Relapsed and Refractory B-cell Lymphoma
NCT ID:
NCT05585996
Condition:
Relapsed and Refractory B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD19 CAR-T and CD19 CAR-DC
Description:
Intravenously injected CAR DC cells and followed by CAR T cells 4 hours later
Arm group label:
Combination therapy of CD19 CAR-T and CD19 CAR-DC
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
Detailed description:
6-18 patients are planned to be enrolled in the dose-escalation trial. The dose of
CD19-CAR-DC was according to the 3+3 dose-escalation principle (0.25×10^6/kg,
0.5×10^6/kg, 0.75×10^6/kg ( ±20%) . CAR-T was 2×10^6/kg . The primary endpoints are DLT,
MTD, and the second endpionts are the overall response rates (CR and PR), overall
survival, and progression-free survival. Based on the results in the dose-escalation
trial, the recommended dose will be determined. Another 52 patients will be enrolled to
continue estimating the safety and efficacy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female participants aged 18 to 75 years old at the time enrollment, with
ECOG Score of ≤ 3;
2. Patients should provide a written informed consent;
3. 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;
4. Life expectancy ≥ 3 months;
5. 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%;
Exclusion Criteria:
1. Prior treatment that included anti-CD19-targeted therapy, CAR T cell therapy, gene
therapy, and allogenic hematopoietic stem cell transplantation (allo-HSCT);
2. Chemotherapy other than lymphodepleting chemotherapy, therapeutic doses of steroids,
immunosuppressive agent, any radiation therapy or anti-tumor targeted therapy
including lenalidomide, bortezomib, ibrutinib, received within 2 weeks before cell
collection;
3. Clinical trial with investigational drug was performed within 4 weeks;
4. History of other cancers;
5. Active hepatitis B or hepatitis C. Hepatitis B: HBV-DNA ≥ 1,000 IU/ml; Hepatitis C:
HCV RNA positive;
6. HIV infection;
7. Uncontrollable infection of active bacteria and fungi;
8. Currently pregnant or refusal to practice birth control within 1 year;
9. Active autoimmune or inflammatory diseases;
10. Central nervous system lymphoma.
Gender:
All
Gender based:
Yes
Gender description:
18-75 years
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hanzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Qian, PhD
Phone:
+8613605801032
Email:
qianwb@zju.edu.cn
Contact backup:
Last name:
Hui Liu, PhD
Phone:
13819198629
Email:
sylen@zju.edu.cn
Start date:
August 1, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05585996
