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Acute Myeloid Leukemia (AML)Phase 1NCT05513612

Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

A Phase 1 study testing Autologous CAR-T cells, Fludarabine and Cyclophosphamide in people with Acute Myeloid Leukemia (AML) and B-cell Non-Hodgkin's Lymphoma (B-NHL), run by Shanghai Pudong Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Autologous CAR-T cells, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Aug 2020to 31 Dec 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and the willingness to sign informed consent.
  • Patients with relapsed or refractory Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM), Adult T-cell Leukemia/Lymphoma (ATL), B-cell Acute Lymphoblastic Leukemia (B-ALL) after at least two cycles of first-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
  • Adequate organ functions:
  • Sufficient bone marrow function evaluated by investigator to receive lymphodepleting preparative regimen;
  • Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance rate (as estimated by Cockcroft Gault) > 30 mL/min/1.73 m^2;
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  • Alanine aminotransferase (ALT) ≤ 5×ULN; and total bilirubin (TBIL) <2.0mg/dL; TBIL of patients with Gilbert's Syndrome or liver involvement must less than 3.0 mg/dL;
  • Left ventricular ejection fraction (LVEF) > 40%.
  • Subjects who have previously received CD19 targeted therapy must have biopsy-proven lymphoma lesions still express CD19 antigen.

Who cannot join

  • Lymphomas involving only the central nervous system (CNS) (subjects with secondary CNS lymphomas are admitted).
  • History of another malignancy that has not been in remission for at least 2 year (the following conditions may be excluded from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumor with low probability of recurrence, limited-stage prostate cancer after treatment, biopsy-proven cervical carcinoma in situ, or PAP smear showing squamous epithelium internal lesions).
  • History of treatment with Alemtuzumab within 6 months prior to leukapheresis, or Fludarabine or Cladribine within 3 months prior to leukapheresis.
  • Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
  • Uncontrolled fungal, bacterial, viral, or other infection.
  • Acute or chronic graft-versus-host disease (GVHD).
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  • History of any of the following cardiovascular diseases within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stent, myocardial infarction, unstable angina, or other clinically significant heart disease.
  • History or clinical evidence of CNS disease.
  • Female subjects who are pregnant or lactating.
  • Prior CAR-T therapy or other genetically modified T cell therapy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

    Shanghai, Shanghai Municipality, 201399

Other trials in China

About this study

Official title: Safety and Efficacy Study of Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies.

Read the detailed description

Chimeric antigen receptor (CAR)-modified 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, efficacy, pharmacokinetic, and pharmacodynamic of the CAR-T cells will be assessed.

Being tested
Autologous CAR-T cells, Fludarabine, Cyclophosphamide
Keywords
CD123 CAR-T, CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, Hematopoietic and Lymphoid Malignancies
Medical subject headings
Leukemia, Myeloid, Acute, Lymphoma, B-Cell, Multiple Myeloma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous CAR-T cellsBiological

    CAR-T cells will be infused intravenously.

  • FludarabineDrug

    Also called Fludara

    Administered according to package insert

  • CyclophosphamideDrug

    Also called Cytoxan

    Administered according to package insert

Study groups in NCT05513612
Study groupRoleWhat they receive
Autologous CAR-T cellsExperimentalA 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.
Receives: Biological: Autologous CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TEAEs

    Incidence and severity of Treatment Emergent Adverse Event.

    Measured: 4 weeks

  2. TRAEs

    Incidence and severity of Treatment Related Adverse Events.

    Measured: 4 weeks

  3. AESIs

    Incidence and severity of AEs of Special Interest.

    Measured: 4 weeks

Secondary outcomes (3)

  1. Duration of Overall Response (DOR)

    Time from documentation of disease response to disease progression.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start1 Aug 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: The study is not initiated and we want it to be withdrawn.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513612
Sponsor's protocol ID
2020-IIT-002-E03
Status last verified
Feb 2023
First submitted
22 Aug 2022
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous CAR-T cells, Fludarabine and Cyclophosphamide in people with Acute Myeloid Leukemia (AML) and B-cell Non-Hodgkin's Lymphoma (B-NHL), run by Shanghai Pudong Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TEAEs (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05513612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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