CD19-CART Treatment for ALL

• Sponsor: Bioray Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03232619
• Collaborator: Second Xiangya Hospital of Central South University (Other)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemia	Biological: CD19 CART	Phase 1/Phase 2

Detailed Description

Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Enrolled patients will receive CD19-CART cell immunotherapy.Enrolled patients will receive CD19-CART cell immunotherapy.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: May 6, 2020
• Actual Study Completion Date: Sep 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD19-CART with a murine scFv All enrolled patients in this arm will receive CD19-CART with a murine scFv.	Biological: CD19 CART; Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.
Experimental: humanized CD19-CART All enrolled patients in this arm will receive humanized CD19-CART.	Biological: CD19 CART; Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.

Outcome Measures

Primary Outcome Measures

1. Radiological assessment [Month1 to Month12]

   Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.

Secondary Outcome Measures

1. The safety of CART immunotherapy [Day 1 to Week 4]

   After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. previously identified as CD19+ ALL.

2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.

3. Expected survival >12W.

4. Creatinine < 2.5 mg/dl.

5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) < 3x normal

6. Bilirubin <2.0 mg/dl

7. Voluntary informed consent is given.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Uncontrolled active infection.

3. Active hepatitis B or hepatitis C infection.

4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.

5. Previously treatment with any gene therapy products.

6. Any uncontrolled active medical disorder that would preclude participation as outlined.

7. HIV infection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Bioray Inc.	Shanghai	Shanghai	China	200240

Sponsors and Collaborators

• Bioray Laboratories
• Second Xiangya Hospital of Central South University

Investigators

• Principal Investigator: Yunxiao Xu, MD, Second Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bioray Laboratories
• ClinicalTrials.gov Identifier: NCT03232619
• Other Study ID Numbers: SHBYCL001
• First Posted: Jul 28, 2017
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• 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
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Sep 22, 2020