Clinical trial NCT05270772: CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
Official title: A Single-arm, Open-label Phase I Study of CAR-T-19 (Anti CD19 scFv Chimeric Antigen Receptor T) Cells for Patients With CD19-positive Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia Under The Age of 25
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: CD19+ Relapse/Refractory B-ALL
Keywords: B-ALL
CAR-T
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 9
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.

Detailed description: B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25.

Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.

Eligibility criteria: Inclusion Criteria:

* Patients with relapse/refractory B-ALL.
* Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
* Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
* Patients who have a life expectancy of at least 12 weeks.
* Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.

Exclusion Criteria:

* Patients with extramedullary relapse (EMR).
* Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
* Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
* Patients with other uncontrolled infection.
* Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
* Patients with active Grade II-IV GVHD within 3 months prior to screening.
* Tumor cells are detected in cerebrospinal fluid.
* Patients who received HSCT within 3 months prior to screening.
* Anticipated other clinical trials within 4 weeks before this trial
* Pregnant or lactating women.
* Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: up to 2 years
measure: Maximum tolerated dose (MTD)
timeFrame: up to 2 years
measure: Adverse events
timeFrame: up to 2 years
Secondary outcomes:
measure: Overall recovery rate (ORR)
timeFrame: up to 2 years
measure: MRD-Negative Rate
timeFrame: up to 2 years
measure: Duration of Response (DOR)
timeFrame: up to 2 years
measure: Progression-free Survival (PFS)
timeFrame: up to 2 years
measure: Overall survival (OS)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Daihong Liu
role: PRINCIPAL_INVESTIGATOR
References: