Description:
The stunning response rate of anti-CD19(cluster of differentiation antigen 19)
auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or
refractory B-cell hematologic malignancies. However, based on open clinical trials, using
patients' T cells might encounter the failure of apheresis available T cells, even if
successful, the time needed for the manufacture could also cause the irreversible disease
progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So
to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell
hematologic malignancies, we launch such a trial that using the edited T cells from healthy
donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell
leukemia or lymphoma.
Title
- Brief Title: Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies
- Official Title: Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial
Clinical Trial IDs
- ORG STUDY ID:
antiCD19-UCAR-T
- NCT ID:
NCT04264039
Conditions
- B-cell Acute Lymphoblastic Leukemia
- B-cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
anti-CD19 UCAR-T cells | | anti-CD19 UCAR-T cells |
Fludarabine | | anti-CD19 UCAR-T cells |
Cytoxan | | anti-CD19 UCAR-T cells |
Melphalan | | anti-CD19 UCAR-T cells |
Purpose
The stunning response rate of anti-CD19(cluster of differentiation antigen 19)
auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or
refractory B-cell hematologic malignancies. However, based on open clinical trials, using
patients' T cells might encounter the failure of apheresis available T cells, even if
successful, the time needed for the manufacture could also cause the irreversible disease
progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So
to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell
hematologic malignancies, we launch such a trial that using the edited T cells from healthy
donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell
leukemia or lymphoma.
Trial Arms
Name | Type | Description | Interventions |
---|
anti-CD19 UCAR-T cells | Experimental | After preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD19 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated | - anti-CD19 UCAR-T cells
- Fludarabine
- Cytoxan
- Melphalan
|
Eligibility Criteria
Inclusion Criteria:
- 1. Diagnosis of recurrent B-cell acute lymphoblastic leukemia (B-ALL), B-cell acute
lymphoblastic lymphoma (B-LLy), or B-non-Hodgkin lymphoma (B-NHL)
2. CD19-positive tumor (≥20% CD19 positive blasts by flow cytometry or
immunohistochemistry (tissue))
3. Hgb ≥ 7.0 (can be transfused)
4. Life expectancy greater than 12 weeks
5. Informed consent explained to, understood by and signed by the patient/guardian.
The patient/guardian is given a copy of informed consent.
Exclusion Criteria:
1. Pregnant or lactating.
2. Tumor in a location where enlargement could cause airway obstruction (per investigator
discretion).
3. Active infection with HIV or HTLV.
4. Clinically significant viral infection or uncontrolled viral reactivation of
EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human
herpesvirus)-6.
5. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial
infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT,
per investigator discretion. Cardiac echocardiography with LVSF (left ventricular
shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or
clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart
Association) III or IV (Confirmation of absence of these conditions on echocardiogram
within 12 months of treatment).
6. CNS abnormalities: Presence of CNS(central nervous system)-3 disease defined as
detectable cerebrospinal blast cells in a sample of CSF(cerebrospinal fluid) with ≥ 5
WBC( white blood cell)s per mm3 (unless negative by the Steinherz/Bleyer algorithm);
Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular
ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS
involvement.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 2 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | the anti-tumor efficiency of anti-CD19 UCAR-T cells |
Time Frame: | 4 weeks after infusion |
Safety Issue: | |
Description: | ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value |
Secondary Outcome Measures
Measure: | the long-term efficiency of anti-CD19 UCAR-T cells |
Time Frame: | 3 and 6 months after infusion |
Safety Issue: | |
Description: | ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Xinqiao Hospital of Chongqing |
Last Updated
February 11, 2020