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Acute Myeloid LeukemiaPhase 1/2NCT05858814

RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT

A Phase 1/2 study testing RC1012 injection (allo-DNT cells) in people with Acute Myeloid Leukemia, run by Guangdong Ruishun Biotech Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
RC1012 injection (allo-DNT cells)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
4 May 2023to 24 Jun 2026
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign an ICF and expect to complete the study procedures for follow-up examinations and treatment.
  • Aged 18 to 70 years (including cut-offs), regardless of gender.
  • Subject must be diagnosed with AML according to World Health Organization (WHO) criteria (2016).
  • The subject has received an allogeneic HSCT within 60-100 days, the percentage of malignant primitive cells in the bone marrow is < 5% after HSCT and STR-PCR shows complete donor chimerism.
  • The subject has one of the following high-risk factors for relapse after allo-HSCT: (1) Failure to achieve remission after two courses of induction chemotherapy. (2) Prior history of Myelodysplastic Syndromes (MDS) or Myeloproliferative Neoplasm (MPN). (3) High leukocytes (≥100×10^9/L) combined with Central Nervous System Leukemia (CNSL); (4) Positive Minimal Residual Disease (MRD) before HSCT; (5) Non-remission or disease progression prior to HSCT; (6) Subject with cytogenetic high-risk factors (except that who can be treated with targeted drugs).
  • The subject has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade <2 (unless the abnormality is tumor-related).
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  • ECOG score 0 to 1.
  • With appropriate organ function:
  • Glutathione aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN);
  • Glutamic aminotransferase (ALT) ≤ 3 times ULN;
  • Total bilirubin ≤ 1.5 times ULN, unless the patient has documented Gilbert syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;
  • Serum creatinine ≤ 1.5 times ULN or a creatinine clearance ≥ 60 ml/min;
  • Hemoglobin ≥ 80 g/L or hemoglobin maintained at that level following transfusion;
  • International Normalized Ratio (INR) ≤ 1.5 times ULN and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN;
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.
  • A platelet count ≥ 50 x 10^9/L or a platelet count maintained at that level following a platelet transfusion;
  • Left ventricular ejection fraction (LVEF) ≥ 45%.
  • Female patients with childbearing potential should have a negative pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female patients without childbearing potential (meeting at least 1 of the following criteria) is described below.
  • Have undergone a hysterectomy or bilateral oophorectomy;
  • Medically recognized as ovarian failure;
  • Medically recognized as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause).

Who cannot join

  • Subject is confirmed to have morphological relapse of leukemia or positive MRD after allo-HSCT.
  • Subject with extramedullary infiltration of leukemia.
  • Suffer from other malignancies within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, post-radical thyroid cancer, and post-radical ductal carcinoma in situ.
  • Has severe respiratory disease (previous or combined history of severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm).
  • A previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia.
  • Evidence of active central nervous system invasion or cranial neuropathy.
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  • Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titration assay not within the normal reference range, positive hepatitis C virus (HCV) antibody and peripheral blood HCV RNA ,positive for human immunodeficiency virus (HIV), or positive for cytomegalovirus (CMV) DNA, or positive syphilis test.
  • Subject who is allergic to the excipients of RC1012 injection or other drugs recommended in the study protocol (e.g., tolimumab, etc.).
  • Serious cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive heart attack, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension.
  • Persons who have previously received an organ transplant or are preparing to receive an organ transplant (except for HSCT).
  • Subject who has received other maintenance therapy drugs after HSCT or who wish to receive other maintenance therapy.
  • Subject with the presence of acute GvHD of degree III to IV or extensive chronic GvHD.
  • Active neurological autoimmune or inflammatory diseases (e.g. Guillain-Barre Syndrome (GBS), Amyotrophic lateral sclerosis (ALS)).
  • Clinically significant active cerebrovascular disease (e.g. cerebral oedema, Posterior Reversible Encephalopathy Syndrome (PRES)).
  • Subject with a life expectancy of less than 3 months.
  • Subject has been involved in other clinical studies within 3 months prior to screening.
  • Subject , in the judgement of the investigator and/or clinical criteria, is contraindicated to any study procedure or have other medical conditions that may place them at unacceptable risk.

Trial locations and contacts

1 site in 1 country.

Xiaoyu Zhu, MD, PhD contact

086-15255456091

bayinhexy@126.com

China1 site, 1 recruiting

  • The First Hospital of the University of Science and Technology of China

    Hefei, Anhui, 230001

    Sir Peng, MD, PhD, 086-0551-62282931, ahslyygcp@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Clinical Trial of RC1012 Injection for the Prevention of Relapse in AML Patients After Allogeneic Hematopoietic Stem Cell Transplantation

To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT

Read the detailed description

This study aims to evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT.

DNT cells are mature T lymphocytes that comprise 3-10% of T cells in human peripheral blood mononuclear cells (PBMC). Allo-DNT cells from healthy donors have been proved to be safe and demonstrated potent cytotoxicity against AML blasts from AML patients in preclinical and preliminary clinical studies. Allo-DNT cells will be collected from healthy donors (NO MHC match needed) and infused into patients. The drug for this study is an off-the-shelf product. Patients DO NOT need to wait for the cell manufacturing.

Being tested
RC1012 injection (allo-DNT cells)
Keywords
allo-HSCT, Cell Therapy, AML, off-the-shelf cell product
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.

  • RC1012 injection (allo-DNT cells)Biological

    RC1012 injection (allo-DNT cells) are from healthy donors and have been proved to be safe and demonstrated potent cytotoxicity against AML blasts from AML patients in preclinical and preliminary clinical studies. Allo- DNT cells will be collected from healthy donors (NO MHC match needed) and injected into patients. The drug for this study is an off-the-shelf product. Patients DO NOT need to wait for the cell manufacturing.

Study groups in NCT05858814
Study groupRoleWhat they receive
RC1012 injection (allo-DNT Cells)ExperimentalThe trial is divided into two parts: Part A is a dose escalation trial with two dose groups (1.0×10^8 cells/kg, 1.5×10^8 cells/kg at day 0, day 28 and day 56), with 6-12 patients planned to be enrolled. Part B is a dose-expansion randomized controlled trial in which 40-60 patients will receive RC1012 infusions at RP2D dose levels.
Receives: Biological: RC1012 injection (allo-DNT cells)

What is being measured

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

  1. Dose-Limiting Toxicity (DLT)

    To evaluate the safety, tolerability, and determine the recommended dosage of allo-DNT Cell Therapy for AML subjects after Allo-HSCT

    Measured: Up to 28 days

  2. Maximum Tolerated Dose (MTD)

    MTD was the highest dose for DLT in ≤1/6 subjects

    Measured: Up to 28 days

  3. Incidence of abnormalities

    Incidence of abnormalities in AE/SAE/laboratory tests/electrocardiograms/vital signs.

    Measured: Up to 28 days

Secondary outcomes (8)

  1. Pharmacokinetics (PK) indicator (Cmax)

    The peak concentration of allo-DNT cells amplified in the peripheral blood (Cmax, detected by Flow Cytometry).

    Measured: Up to 2 years

  2. Pharmacokinetics (PK) indicator (AUC)

    Allo-DNT cells blood concentrations will be measured at different time points to evaluate the area under the curve (AUC). (AUC, detected by Flow Cytometry).

    Measured: Up to 2 years

  3. Pharmacokinetics (PK) indicator (Tmax)

    Allo-DNT cells blood concentrations will be measured at different time points to evaluate the peak time (Tmax) in peripheral blood. Tmax is defined as the time to reach the highest concentration (Tmax, detected by Flow Cytometry).

    Measured: Up to 2 years

  4. Pharmacokinetics (PK) indicator (T1/2)

    Allo-DNT cells blood concentrations will be measured at different time points to evaluate the elimination half-life in hours (T1/2). T1/2 is defined as the time point when the concentration of allo-DNT reaches half of maximum in a patient's peripheral blood (T1/2, detected by Flow Cytometry).

    Measured: Up to 2 years

  5. Recurrence rate at 6 months

    Record the proportion of patients with recurrence in the study.

    Measured: Up to 6 months

  6. Relapse-free survival (RFS)

    Relapse-free survival is the time from study enrollment until documented disease relapse, or death from any cause.

    Measured: Up to 2 years

  7. GvHD-free and relapse-free survival (GRFS)

    GRFS is the time from study enrollment until documented disease relapse, or death, or GvHD occur from any cause.

    Measured: Up to 2 years

  8. 2-year overall survival

    From the date of entry into the clinical study until death from any cause.

    Measured: Up to 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 posted15 May 2023
  2. Study start4 May 2023
  3. Primary completion27 May 2024 (estimated)
  4. Study completion24 Jun 2026 (estimated)

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05858814
Sponsor's protocol ID
RC1012-AML002
Status last verified
Jan 2023
First submitted
5 May 2023
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RC1012 injection (allo-DNT cells) in people with Acute Myeloid Leukemia, run by Guangdong Ruishun Biotech Co., Ltd 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 21 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 19 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 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?

Results are not available in the source record.

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

Contact Xiaoyu Zhu, MD, PhD (086-15255456091, bayinhexy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: Up to 28 days). 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 NCT05858814.

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 19 May 2023.

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