CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03064269
• Collaborator: The First Affiliated Hospital of Soochow University (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 83.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Condition or Disease	Intervention/Treatment	Phase
B-cell Acute Lymphocytic Leukemia	Biological: CD19 CAR-T cells	Phase 1

Detailed Description

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Treatment
• Official Title: CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
• Actual Study Start Date: Mar 1, 2017
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Feb 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.	Biological: CD19 CAR-T cells; CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Outcome Measures

Primary Outcome Measures

1. The complete remission (CR) rate [Participants will be followed for the duration of the treatment, an expected average of 12 months]

   The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia

2. ALT/ AST 《 3x normal

3. Creatinine 《 3x normal

4. Age:10-60.

5. Signed informed consent

Exclusion Criteria:

1. Active hepatitis B , hepatitis C or HIV infection

2. Uncontrolled active infection

3. Pregnancy or breast-feeding women

4. Survival less than four weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou		China

Sponsors and Collaborators

• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• The First Affiliated Hospital of Soochow University

Investigators

• Principal Investigator: Lei Yu, Ph.D, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• ClinicalTrials.gov Identifier: NCT03064269
• Other Study ID Numbers: UnicarTherapy
• First Posted: Feb 27, 2017
• Last Update Posted: May 19, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: CNS B cell acute lymphocytic leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of May 19, 2022