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Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

Primary Purpose

Relapsed/Refractory Hematological Malignancies, Lymphoma, Myeloma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous CAR-T cells
Fludarabine
Cyclophosphamide
Sponsored by
The Affiliated People's Hospital of Ningbo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Hematological Malignancies focused on measuring CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, CD123 CAR-T

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.
  2. Positive expression of specific antigens.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.

  4. Adequate organ functions:

    • Serum bilirubin ≤ 35 μmol/L;
    • Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2;
    • Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
    • Brain natriuretic peptide (BNP)<80 pg/mL.
  5. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Exclusion Criteria:

  1. History of allergy to any of the drugs involved in the protocol.

  2. History of cardiac diseases:

    • Left ventricular ejection fraction (LVEF) < 50%;
    • Class III or IV heart failure as defined by the New York Heart Association (NYHA).
  3. History of another malignancy tumor.
  4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
  5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
  6. Uncontrolled fungal, bacterial, viral, or other infection.
  7. Female subjects who are pregnant or lactating.

Sites / Locations

  • The Affiliated People's Hospital of Ningbo UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous CAR-T cells

Arm Description

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.

Outcomes

Primary Outcome Measures

TEAEs
Incidence and severity of Treatment Emergent Adverse Event.
TRAEs
Incidence and severity of Treatment Related Adverse Events.
AESIs
Incidence and severity of AEs of Special Interest.

Secondary Outcome Measures

Objective Response Rate (ORR) (PR+CR)
The proportion of patients with complete response(CR) or partial response(PR)
Progression-Free Survival (PFS)
PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Overall survival (OS)
OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.

Full Information

First Posted
September 1, 2022
Last Updated
September 1, 2022
Sponsor
The Affiliated People's Hospital of Ningbo University
Collaborators
UTC Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05528887
Brief Title
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
Official Title
Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated People's Hospital of Ningbo University
Collaborators
UTC Therapeutics Inc.

4. Oversight

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

5. Study Description

Brief Summary
The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.
Detailed Description
CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Hematological Malignancies, Lymphoma, Myeloma, Leukemia
Keywords
CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, CD123 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
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous CAR-T cells
Arm Type
Experimental
Arm Description
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.
Intervention Type
Biological
Intervention Name(s)
Autologous CAR-T cells
Intervention Description
D0: CAR-T cells will be infused intravenously.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
Fludara
Intervention Description
D-5 to D-3: Fludarabine (30 mg/m^2/day) will be administered intravenously for 3 days.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
D-5 to D-3: Cyclophosphamide (500 mg/m^2/day) will be administered intravenously for 3 days.
Primary Outcome Measure Information:
Title
TEAEs
Description
Incidence and severity of Treatment Emergent Adverse Event.
Time Frame
4 weeks
Title
TRAEs
Description
Incidence and severity of Treatment Related Adverse Events.
Time Frame
4 weeks
Title
AESIs
Description
Incidence and severity of AEs of Special Interest.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) (PR+CR)
Description
The proportion of patients with complete response(CR) or partial response(PR)
Time Frame
12 months
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Time Frame
12 months
Title
Overall survival (OS)
Description
OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy. Positive expression of specific antigens. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2. Adequate organ functions: Serum bilirubin ≤ 35 μmol/L; Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2; Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN); Brain natriuretic peptide (BNP)<80 pg/mL. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures. Exclusion Criteria: History of allergy to any of the drugs involved in the protocol. History of cardiac diseases: Left ventricular ejection fraction (LVEF) < 50%; Class III or IV heart failure as defined by the New York Heart Association (NYHA). History of another malignancy tumor. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation. Uncontrolled fungal, bacterial, viral, or other infection. Female subjects who are pregnant or lactating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Lu
Phone
86-13486090834
Email
814871416@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Chen
Phone
86-13805888089
Email
13805888089@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Lu
Organizational Affiliation
The Affiliated People's Hospital of Ningbo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated People's Hospital of Ningbo University
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Chen
Phone
+8613805888089
Email
13805888089@163.com

12. IPD Sharing Statement

Learn more about this trial

Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

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