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CART-19 Cells For MRD Positive CD19+ ALL

CART-19 Cells For Patients With Minimal Residual Disease (MRD) Positive CD19+ Acute Lymphoblastic Leukemia

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03027739
Acronym
CCFMPCA
Enrollment
20
Registered
2017-01-23
Start date
2016-11-30
Completion date
2020-12-31
Last updated
2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Brief summary

CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.

Interventions

BIOLOGICALCART-19

CART-19 cells treated

Sponsors

Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Signed written informed consent * Aged between 1-60 years * Patients with MRD positive CD19+ ALL * Cardiac: Left ventricular ejection fraction ≥ 50% * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70%

Exclusion criteria

* Pregnant or lactating females. * Any co-morbidity precluding the administration of CART-19 cells.

Design outcomes

Primary

MeasureTime frame
Leukemia free survival1 year

Secondary

MeasureTime frame
Adverse events that are related to treatment1 year

Countries

China

Contacts

Primary ContactJianda Hu, Prof.M.D.Ph.D
drjiandahu@163.com86-13959169016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026