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The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chimeric antigen receptor T cells | Biological | Dose CAR+ cells/kg B-cell lymphoma 4×10^6 Acute lymphocytic leukemia 2×10^6 Chronic lymphocytic leukemia 10×10^6 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12. | 12 weeks |
| Overall Survival | from the time of enrollment to death from any cause or the date of the last follow-up visit | 6 months,1 year, 2 years |
| Progression-free Survival | the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit | 12 weeks,6 months,1 year, 2 years |
| Event-free Survival | the time from enrollment to any events, or the date of the last follow-up visit | 12 weeks,6 months,1 year, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Non-haematological dose-limiting toxicities was any toxicity of grade 3 or higher occurring within 28 days of XLCART001 infusion judged possibly related to the treatment regimen.The following toxicities were not considered dose limiting toxicities: tumor lysis syndrome, abnormal electrolytes responding to supplementation, hypoalbuminemia, liver dysfunction resolving to ≤grade 2 within 14 days, transient (<72 hours) grade 4 hepatic enzyme abnormality, and grade 3 or 4 fever or neutropenic fever. |
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Inclusion Criteria:
Age ≥18 years, male and female,
Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry
No effective treatment
Patients must have a measurable or evaluable disease at the time of enrollment.
Adequate organ system function including:
At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments)
No contraindications of peripheral blood apheresis
Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
ECOG score 0-2, expected survival ≥ 12 weeks
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital | Nanjin | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515338 | Derived | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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| 28 days |
| Number of CAR-T cells | The number of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction | Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years |
| Duration of CAR-T cells | The duration of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction | Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |