Clinical trial NCT05225831: Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia
Official title: Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in Patients With R/R B-Cell Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: CD19+ and CD 22+ B-ALL
Keywords: CD19
CD22
B-ALL
CAR-T
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hebei Yanda Ludaopei Hospital
First posted: 2022-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

Eligibility 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 insufficiency；
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.

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to 28 days
measure: Efficacy: Remission Rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: Efficacy:duration of response (DOR)
timeFrame: 24 months post CAR-T cells infusion
measure: Efficacy: progression-free survival (PFS)
timeFrame: 24 months post CAR-T cells infusion
measure: CAR-T proliferation
timeFrame: 3 months post CAR-T cells infusion
measure: Cytokine release
timeFrame: First month post CAR-T cells infusion
Other outcomes:
Locations:
city: Langfang
country: China
facility: Hebei Yanda Ludaopei Hospital
state: Hebei
Study officials:
affiliation: Beijing Lu Daopei Hospital
name: Peihua Lu, PhD&MD
role: PRINCIPAL_INVESTIGATOR
References: