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AMLPhase 1NCT05256277

NK Cell Therapy for AML

A Phase 1 study testing CT101a in people with AML, run by Zhejiang University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-arm, open-label, non-randomized, multiple-dose, phase 1 dose escalation study evaluating the safety, efficacy and PK of CT101a in patients with relapsed/refractory acute myeloid leukemia. Primary Objective: To evaluate the safety and tolerability of CT101a and estimate the MTD in Chinese patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML
What is being tested?
CT101a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
28 Dec 2021to 3 Apr 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with relapsed or refractory AML:
  • For patients with relapsed AML: after complete response (CR), leukemia cells or blast cells in the bone marrow reappear >5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy).
  • For patients with refractory AML: initial cases who have been treated with standard regimens for 2 courses of treatment that are not effective; after CR, they undergo consolidation and intensive treatment and relapse within 12 months; those who relapse after 12 months but are ineffective after conventional chemotherapy; those who relapse for 2 or multiple times.
  • AML patients with disease progression after transplantation.
  • Male or female ≥ 18 years old.
  • ECOG Performance Status 0 to 2.
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  • Life expectancy ≥3 months.
  • Available HLA-haploidentical donor meeting the following criteria:
  • Related donor (parent, sibling, offspring, or offspring of sibling);
  • At least 18 years of age;
  • HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A\&B locus;
  • In general, the donor is healthy and can tolerate leukapheresis for collecting NK cells required in this study;
  • Negative for HCV antibody, five items of HBV, HIV antibody and syphilis on donor viral screening;
  • The female donor of childbearing potential must have a negative pregnancy test within screening.
  • Voluntary written consent to participate in this study.
  • Adequate organ function as defined below:
  • Total bilirubin<2 mg/dL;
  • AST(SGOT)/ALT(SGPT) <3.0 x ULN;
  • Creatinine within normal institutional limits;
  • Oxygen saturation ≥90% on room air;
  • Ejection fraction ≥35%.
  • Able to be off corticosteroids and any other immune suppressive medications beginning on 3 days before the CT101a infusion and continuing until 28 days after the CT101a infusion. However, use of low-level corticosteroids is permitted at the judgment of the investigator if deemed medically necessary. Low-level corticosteroid use is defined as 10mg or less of prednisone (or equivalent for other steroids) per day.
  • Women of childbearing potential must have a negative pregnancy test within screening. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • Acute or chronic GVHD with ongoing active systemic treatment.
  • Circulating blast count >30,000/μL by morphology or flow cytometry.
  • Prior treatment with ML NK cell therapy within 3 months prior to screening.
  • Patients who are undergoing any approved or investigational chemotherapy and anti-leukemic therapy with small molecule-targeted drugs within the 14 days prior to the first dose of fludarabine.
  • Presence of any severe or uncontrolled systemic disease or condition.
  • Patients with active infection requiring systemic therapy within 2 weeks prior to screening.
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  • HBsAg positive and HBV DNA is detectable or above the cut-off value or positive HCV antibody or positive HIV antibody or positive syphilis test.
  • New progressive pulmonary infiltrates on screening chest X-ray or chest CT scan that have not been evaluated with bronchoscopy.
  • Patients with a significant cardiovascular disease or condition.
  • Inadequate bone marrow reserve or organ function.
  • Other patients judged inappropriate for this study by the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital，College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Phase 1 Study of Evaluating Preliminary Safety and Efficacy of CT101a in the Treatment of Relapsed or Refractory (r/r) AML Patients

This is a single-arm, open-label, non-randomized, multiple-dose, phase 1 dose escalation study evaluating the safety, efficacy and PK of CT101a in patients with relapsed/refractory acute myeloid leukemia.

Primary Objective:

Read more

To evaluate the safety and tolerability of CT101a and estimate the MTD in Chinese patients.

Secondary Objective:

To determine the preliminary efficacy of CT101a in the treatment of r/r AML by IWG response rate; To determine the duration of response, time to progression, disease-free survival, and overall survival of AML patients treated with CT101a.

Exploratory Objective:

To investigate and analyze the correlation between the donor KIR gene and the efficacy in the subject.

To explore the feasibility and safety of multiple doses of CT101a in the treatment of r/r AML.

To detect blood samples and bone marrow samples before and after CT101a infusion by single cell sequencing method, and to perform difference analysis.

Read the detailed description

This is a single-arm, open-label, non-randomized, multiple-dose, phase 1 dose escalation study evaluating the safety, efficacy and PK of CT101a in patients with relapsed/refractory AML.

This clinical study is to evaluate the safety, MTD and preliminary efficacy of CT101a in patients with relapsed/refractory AML. Up to 9-18 patients will be enrolled.

Conditions
AML
Being tested
CT101a
Keywords
cytokine-induced memory-like NK cells, relapsed or refractory acute myeloid leukemia
Medical subject headings
Recurrence, Leukemia, Myeloid, Acute

What participants receive

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

  • CT101aDrug

    cytokine-induced memory-like NK cells

Study groups in NCT05256277
Study groupRoleWhat they receive
CT101aExperimental1 dose infusion
Receives: Drug: CT101a

What is being measured

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

  1. DLT/MTD

    The severity of adverse events is graded according to NCI-CTCAE version 5.0, and the investigator will determine whether the subject has DLT.

    Taking into account the clinical characteristics of AML patients, DLT is defined as: During the 28-day DLT observation period after CT101a infusion, the subject still has any of the following conditions related to the study drug despite the treatment measures taken:

    1. Non-hematology related DLT: Any non-hematologic AE ≥ Grade 3 that is caused by CT101a treatment and does not resolve to below Grade 2 within 3 days; infusion-related reactions will not be considered as DLT.

    Patients with clinical progression of AML after CT101a infusion can receive cytoreductive therapy (such as hydroxyurea, cytarabine) to control their disease, and maintain the DLT assessment during the entire DLT period, but any AE related to cytoreductive therapy will not be considered as DLT.

    Measured: 28 days

Secondary outcomes (6)

  1. Safety parameters

    adverse events (AEs), serious adverse events (SAEs), laboratory test abnormalities, ECG changes and vital signs, physical examination abnormalities, etc.

    Measured: 2 years

  2. overall response rate

    The overall response rate (ORR, CR+CRi+PR) after cell infusion

    Measured: 2 years

  3. DOR

    DOR is defined as the time from the first date of the tumor achieving CR or CRi, until the first date of disease progression or death from any cause

    Measured: 2 years

  4. OS

    OS is defined as the time from the date of CT101a infusion until death from any cause

    Measured: 2 years

  5. TTP

    TTP is defined as the time from the date of CT101a infusion until the first date of leukemia progression.

    Measured: 2 years

  6. LFS

    LFS is defined as the time from the date of CT101a infusion until the first date of leukemia progression or relapse or death from any cause.

    Measured: 2 years

Timeline

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

  1. First posted25 Feb 2022
  2. Study start28 Dec 2021
  3. Primary completion28 Aug 2022
  4. Study completion3 Apr 2023

Why it stopped: A new study is planed to replace the current study due to IP upgrade

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05256277
Sponsor's protocol ID
CT101a-001
Status last verified
May 2023
First submitted
8 Feb 2022
Last updated
16 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT101a in people with AML, run by Zhejiang University 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 24 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 May 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 stopped early (reason given: A new study is planed to replace the current study due to IP upgrade). Results are not available in the source record.

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?

DLT/MTD (time frame: 28 days). 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 NCT05256277.

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 16 May 2023.

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