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

September 1, 2022 updated by: The Affiliated People's Hospital of Ningbo University

Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315101
        • Recruiting
        • The Affiliated People's Hospital of Ningbo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous CAR-T cells
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.
Biological: Autologous CAR-T cells
D0: CAR-T cells will be infused intravenously.
Drug: Fludarabine
D-5 to D-3: Fludarabine (30 mg/m^2/day) will be administered intravenously for 3 days.
Other Names:
  • Fludara
Drug: Cyclophosphamide
D-5 to D-3: Cyclophosphamide (500 mg/m^2/day) will be administered intravenously for 3 days.
Other Names:
  • Cytoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TEAEs
Time Frame: 4 weeks
Incidence and severity of Treatment Emergent Adverse Event.
4 weeks
TRAEs
Time Frame: 4 weeks
Incidence and severity of Treatment Related Adverse Events.
4 weeks
AESIs
Time Frame: 4 weeks
Incidence and severity of AEs of Special Interest.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 12 months
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.
12 months
Objective Response Rate (ORR) (PR+CR)
Time Frame: 12 months
The proportion of patients with complete response(CR) or partial response(PR)
12 months
Progression-Free Survival (PFS)
Time Frame: 12 months

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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated People's Hospital of Ningbo University

Collaborators

UTC Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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