Overview

Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia

Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Collaborator:
Hebei Yanda Ludaopei Hospital
Treatments:
Cyclophosphamide
Fludarabine
Criteria
Inclusion Criteria:

1. Sign the informed consent and be willing and able to comply with the visit, treatment
regimen, laboratory examination and other requirements of the study as stipulated in
the trial flow chart;

2. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following
criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a)
no remission after six weeks of induction therapy or no remission after two courses of
induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after
chemotherapy and no remission after at least one salvage treatment; c) relapsed after
hematopoietic stem cell transplantation;

3. ECOG Scores: 0~2

4. CD19 positive and CD22 positive were detected by immunohistochemistry or flow
cytometry;

5. Estimated survival time>3 months;

6. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the
last radiotherapy or systemic treatment.

7. For patients with only extramedullary recurrence of B-ALL, there must be at least one
assessable lesion.

Exclusion Criteria:

1. Serious cardiac insufficiencyï¼›

2. Has a history of severe pulmonary function damaging;

3. Presence of other malignant tumors.

4. Presence of active fungal, bacterial, viral, or other infection requiring IV
antibiotics for management.

5. Presence of other severe autoimmune diseases or immunodeficiency disease;

6. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);

7. Known positive serology for human immunodeficiency virus (HIV) or syphilis。

8. Has a history of serious allergies on biological products (including antibiotics);

9. Female patients who are under pregnancy and/or lactation, or planing on pregnancy for
the next 12 months.

10. Any other situations that the researchers believe will affect the results of the
study.