Description:
The prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is
poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19
CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell
hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target
expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical
experiments is cheerful.however, how to select the functional T cells from the malignant T
cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the
majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of
the host as the material of anti-CD7 universal CAR-T cells could be accessible and
affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell
hematologic malignancies.
Title
- Brief Title: Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies
- Official Title: Anti-CD7 Universal CAR-T Cells for CD7+ T/NK Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial
Clinical Trial IDs
- ORG STUDY ID:
antiCD7-UCAR-T
- NCT ID:
NCT04264078
Conditions
- T-cell Leukemia
- T-cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
CD7 UCAR-T cells | | anti-CD7 UCAR-T cells |
Fludarabine | | anti-CD7 UCAR-T cells |
Cytoxan | | anti-CD7 UCAR-T cells |
Melphalan | | anti-CD7 UCAR-T cells |
Purpose
The prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is
poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19
CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell
hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target
expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical
experiments is cheerful.however, how to select the functional T cells from the malignant T
cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the
majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of
the host as the material of anti-CD7 universal CAR-T cells could be accessible and
affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell
hematologic malignancies.
Trial Arms
Name | Type | Description | Interventions |
---|
anti-CD7 UCAR-T cells | Experimental | After preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD7 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated | - CD7 UCAR-T cells
- Fludarabine
- Cytoxan
- Melphalan
|
Eligibility Criteria
Inclusion Criteria:
- 1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute
lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including
Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma
(EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral
T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell
leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal
NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher))
2. CD7-positive tumor (≥20% CD7 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.
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: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | the anti-tumor efficiency of anti-CD7 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 standralized uptake value |
Secondary Outcome Measures
Measure: | the long-term efficiency of anti-CD7 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 standralized uptake value |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Xinqiao Hospital of Chongqing |
Last Updated
June 28, 2021