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CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL

Primary Purpose

CD19+ Relapse/Refractory B-ALL

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T-19 Cells
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD19+ Relapse/Refractory B-ALL focused on measuring B-ALL, CAR-T

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR-T-19 Cells

Arm Description

The patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10^6/kg to 5.0×10^6/kg CAR+ cells.

Outcomes

Primary Outcome Measures

Dose limiting toxicity (DLT)
DLT within 28 days (±3 days) after CAR-T-19 infusion.
Maximum tolerated dose (MTD)
The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Adverse events
Percentage of subjects with adverse events.

Secondary Outcome Measures

Overall recovery rate (ORR)
Percentage of subjects who achieved complete response (CR) and incomplete hematologic recovery (CRi) for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
MRD-Negative Rate
Percentage of subjects with MRD-negative CR and incomplete blood and MRD-negative CRi for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Duration of Response (DOR)
The time from achieving CR and CRi for the first time to recurrence or death from any cause
Progression-free Survival (PFS)
The time from CAR-T-19 infusion to recurrence, progression or death from any cause, whichever occurs first.
Overall survival (OS)
The time from CAR-T-19 infusion to death from any cause.

Full Information

First Posted
February 26, 2022
Last Updated
February 26, 2022
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05270772
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
September 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD19+ Relapse/Refractory B-ALL
Keywords
B-ALL, CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAR-T-19 Cells
Arm Type
Experimental
Arm Description
The patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10^6/kg to 5.0×10^6/kg CAR+ cells.
Intervention Type
Biological
Intervention Name(s)
CAR-T-19 Cells
Intervention Description
T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10^6/kg,1.5×10^6/kg, 5.0×10^6/kg CAR+ cells.
Primary Outcome Measure Information:
Title
Dose limiting toxicity (DLT)
Description
DLT within 28 days (±3 days) after CAR-T-19 infusion.
Time Frame
up to 2 years
Title
Maximum tolerated dose (MTD)
Description
The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Time Frame
up to 2 years
Title
Adverse events
Description
Percentage of subjects with adverse events.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Overall recovery rate (ORR)
Description
Percentage of subjects who achieved complete response (CR) and incomplete hematologic recovery (CRi) for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Time Frame
up to 2 years
Title
MRD-Negative Rate
Description
Percentage of subjects with MRD-negative CR and incomplete blood and MRD-negative CRi for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Time Frame
up to 2 years
Title
Duration of Response (DOR)
Description
The time from achieving CR and CRi for the first time to recurrence or death from any cause
Time Frame
up to 2 years
Title
Progression-free Survival (PFS)
Description
The time from CAR-T-19 infusion to recurrence, progression or death from any cause, whichever occurs first.
Time Frame
up to 2 years
Title
Overall survival (OS)
Description
The time from CAR-T-19 infusion to death from any cause.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daihong Liu
Phone
+8613681171597
Email
daihongrm@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daihong Liu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daihong Liu
Phone
+8613681171597
Email
daihongrm@163.com
First Name & Middle Initial & Last Name & Degree
Daihong Liu

12. IPD Sharing Statement

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CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL

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