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Acute Myeloid LeukemiaPhase 1/2NCT04835519

Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1/2 study testing chimeric antigen receptor T cell in people with Acute Myeloid Leukemia and Relapse Leukemia, run by Beijing Boren Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a open-label, nonramdominzed, single-arm, Phase I/II Study to evaluate safety and tolerability of functionally enhanced CD33 CAR-T cells in subjects with relapsed or refractory acute myeloid leukemia. 25 subjects will be enrolled. Read more about this study

Who is it for?
Ages 1 year to 70 years
What is being tested?
chimeric antigen receptor T cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteChina
Study dates
8 Apr 2021to 19 May 2023
Phase
Phase 1/2
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 1 year to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Candidates with relapse or refractory CD33+ acute myeloid leukemia, who have progressed on after treatment with all standard therapies or intolerant of standard care, have limited prognosis with currently available therapies and had no available curative treatment options (such as HSCT or chemotherapy)
  • Male or female, aged 1-70 years
  • No serious allergic constitution
  • Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al.,1982) score 0 to 2
  • Have life expectancy of at least 60 days based on investigator's judgement
  • CD33 positive in bone marrow or cerebrospinal fluid (CSF) by flow cytometry, or CD33 positive in tumor tissues by immunohistochemistry; (CD33 positive criteria: Flow cytometry: Positive: > 80% of tumor cells expressed CD33 and the MFI of CD33 is the same as that in normal myeloid cells; Dim: > 80% of tumor cells expressed CD33, but the MFI of CD33 is lower than that in normal myeloid cells as least as 1log; Partial positive: 20-80% of tumor cells expressed CD33 and the MFI of CD33 is the same as that in normal myeloid cells. Tumor tissue immunohistochemistry: Positive > 30% tumor cells expressed CD33);
  • Provide a signed informed consent before any screening procedure; subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Pediatric patients aged 1-7 years could be recruited after signing an informed consent form by a legal surrogate (Guardian); pediatric patients aged 8-18 years need to be sufficiently conscious and voluntarily signed an informed consent form, and their legal surrogates (guardians) were also required to sign a written informed consent form.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Intracranial hypertension or disorder of consciousness
  • Symptomatic heart failure or severe arrhythmia
  • Symptoms of severe respiratory failure
  • Complicated with other types of malignant tumors
  • Diffuse intravascular coagulation
Show all 15Show fewer
  • Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
  • Suffering from septicemia or other uncontrollable infections
  • Patients with uncontrollable diabetes
  • Severe mental disorders
  • Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
  • Have received organ transplantation (excluding hematopoietic stem cell transplantation);
  • Reproductive-aged female patients with positive blood HCG test
  • Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
  • Patients with tumor burden higher than 30% requiring reinfusion of autologous CAR-T cells.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Boren Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: Open-Label, Nonramdominzed, Single-Arm Phase I/II Study to Evaluate the Safety and Tolerability of Functionally Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

This is a open-label, nonramdominzed, single-arm, Phase I/II Study to evaluate safety and tolerability of functionally enhanced CD33 CAR-T cells in subjects with relapsed or refractory acute myeloid leukemia. 25 subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 5 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m^2( body surface area) and cyclophosphamide 250 mg/m^2( body surface area) for 3 days. Then the Bayesian optimal interval phase I/II (Boin12) trial design will be used in this study: The protocol preset 2 dose levels: Dose 1 (DL-1) was 5×10^5 (±20%) CAR T cells/kg, and dose 2 (DL-2) was 1×10^6 (±20%) CAR T cells/kg. Phase I was the dose exploration phase. After determining the optimal biological dose (OBD), phase II will be expanded at the OBD dose by 10 cases, enrollment will reach 25 cases, and the trial will be discontinued. Moreover, the first 3 enrolled subjects per dose group will be on one by one dosing regimen.

The expected initial dose of 5×10^5 (±20%) CAR T cells/kg could not be achieved due to preparation problems and should be placed in the reduced dose group. The number of cells will be collected by the above regimen as far as possible. If this is not possible, subjects can still enter the study upon investigator consideration but require documentation of dosing. The lowest dose is 1×10^5 CAR T cells/kg (±20%), and the highest dose is 1×10^6 CAR T cells/kg (±20%). If the dose is out of the range mentioned above, entry into the trial will not be considered.

Being tested
chimeric antigen receptor T cell
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • chimeric antigen receptor T cellBiological

    Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 5 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m^2( body surface area) and cyclophosphamide 250 mg/m^2( body surface area) for 3 days. Then this study will be using the Bayesian optimal interval phase I/II (Boin12) trial design. The protocol preset 2 dose levels: Dose 1 (DL-1) was 5×10^5 (±20%) CAR T cells/kg, and dose 2 (DL-2) was 1×10^6 (±20%) CAR T cells/kg. If the above dose cannot be met, subjects can still enter the study upon investigator consideration but require documentation of dosing. The lowest dose is 1×10^5 CAR T cells/kg (±20%), and the highest dose is 1×10^6 CAR T cells/kg (±20%). If the dose is out of the range mentioned above, entry into the trial will not be considered.

Study groups in NCT04835519
Study groupRoleWhat they receive
chimeric antigen receptor T cell treatmentExperimentalNot described
Receives: Biological: chimeric antigen receptor T cell

What is being measured

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

  1. Incidence and type of dose-limiting toxicity (DLT)

    Measured: day 21 post intravenous CAR T cell infusion

  2. Incidence and severity of adverse events (AE)

    Measured: day 28 post intravenous CAR T cell infusion

Secondary outcomes (2)

  1. CR (complete remission) rate and CRi (complete remission with incomplete blood count recovery) rate to the CAR-T treatment

    Measured: day 15 post intravenous CAR T cell infusion

  2. CR rate and CRi rate to the CAR-T treatment

    Measured: day 28 post intravenous CAR T cell infusion

Timeline

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

  1. First posted8 Apr 2021
  2. Study start8 Apr 2021
  3. Primary completion19 May 2023
  4. Study completion19 May 2023

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835519
Sponsor's protocol ID
BRYY-IIT-LCYJ-2021-003
Status last verified
Feb 2023
First submitted
5 Apr 2021
Last updated
21 Jun 2024
Results posted
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 1/2 study testing chimeric antigen receptor T cell in people with Acute Myeloid Leukemia and Relapse Leukemia, run by Beijing Boren 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 21 Jun 2024. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence and type of dose-limiting toxicity (DLT) (time frame: day 21 post intravenous CAR T cell infusion). The study lists 2 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 NCT04835519.

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 21 Jun 2024.

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