AzTrials
AzTrials

B-cell Acute Lymphoblastic LeukemiaPhase 1NCT04595162

A Study of GC019F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL

A Phase 1 study testing GC019F in people with B-cell Acute Lymphoblastic Leukemia, run by Peking University Third Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of GC019F CAR-T cell immunotherapy in relapsed or refractory B-ALL. The study will include 6-12 subjects to receive GC019F therapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
B-cell Acute Lymphoblastic Leukemia
What is being tested?
GC019F
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
15 Mar 2021to 15 Dec 2035
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Aged 18-70 years;
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 2;
  • Life expectancy≥12 weeks;
  • CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry;
  • Relapsed or refractory B- ALL: a) Refractory B- ALL: Fail to achieve a CR after 2 cycles of a standard induction chemotherapy regimen or one-line/multi-line salvage chemotherapy; b) Relapsed B- ALL: Relapse after remission for the first time in 12 months or relapse after one-line/multi-line salvage chemotherapy; Relapse is defined as recurrence of primitive cell in peripheral blood or bone marrow(>5%) after remission; c)Relapse after autologous stem cell transplantation or allogeneic hematopoietic stem cell transplantation; d)Patients with Philadelphia chromosome positive(Ph+) ALL were eligible if they were intolerant to or had failed two lines of tyrosine kinase inhibitor (TKI) therapy, or had t315i mutation.
  • Did not receive hematopoietic stem cell transplantation≤6 months prior to enrollment;
Show all 11Show fewer
  • Adequate organ function defined as: a) Creatinine clearance (as estimated by Cockcroft Gault method) >60 mL/min; b) Serum ALT/AST <2.5 ULN; c) Total bilirubin <1.5 ULN (subjects with Gilbert's syndrome≤3 ULN); d) Cardiac ejection fraction≥50%, no evidence of clinically significant pericardial effusion as determined by an ECHO; e) No clinically significant pleural effusion; f) Baseline oxygen saturation >92% on room air;
  • Females of reproductive age must be in non-lactation period. Females of childbearing potential must have a negative serum or urine pregnancy test. All subjects must use medical-approved-contraception (such as intrauterine device and contraceptive drugs) during the treatment and in 2 years after cell transfusion treatment; Males should avoid sperm donation;
  • Venous access can be established, peripheral blood mononuclear cells (PBMC) can be collected in researcher's judgement;
  • The subject agrees to and sign informed consent form;
  • The subject can communicate well with the researcher, is willing and able to comply with the research plans, and finish the research according to the research rule.

Who cannot join

  • Isolated extramedullary leukemia or isolated extramedullary disease relapse;
  • Central nervous system leukemia involved CNS3;
  • Concomitant malignancy other than cured non-melanoma skin cancer or cervical carcinoma in situ or localized prostate cancer or superficial bladder cancer or ductal carcinoma in situ or diagnosis of other malignancy exceeds 5 years without relapse or treatment during the 5 years;
  • Any result of the following infectious disease tests is positive: HIV; HCV; HBsAg; or HBcAb positive with HBV DNA copies positive; TPPA;
  • Live vaccine ≤4 weeks prior to enrollment;
  • For Ph+ ALL, TKI therapy ≤1 week prior to enrollment;
Show all 18Show fewer
  • History of anti-CD19 therapy or CAR-T or other gene-editing T cell therapy;
  • Presence of ≥ grade 2 acute graft-versus-host disease (GVHD, Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) that require treatment ≤4 weeks prior to enrollment, or during the study period the subject is required to receive anti-GCHD therapy in researcher's judgement;
  • Presence of concomitant disease that require systemic steroids or other immune suppressive therapy during the study period in researcher's judgement; Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) ≤4 weeks prior to enrollment;
  • CNS stereotactic radiotherapy ≤4 weeks prior to enrollment;
  • Toxicities related to previous therapy did not relieved to ≤1 grade, except hematological toxicity and alopecia;
  • Known life-threatening hypersensitivity to cyclophosphamide or fludarabine, or presence of other intolerant conditions, or severe allergic constitution;
  • Patients with active autoimmune disease (e.g., systemic lupus erythematosus, sjogren syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, hypothyroidism which can be controlled by thyroid hormone replacement therapy is an exception);
  • For patients that underwent or plan to undergo major surgical operation before CAR-T treatment, major surgery which required general anesthesia happened ≤4 weeks prior to enrollment, or did not be fully recovered and clinically stable prior to enrollment, or be anticipated to undergo major surgical operation which requires general anesthesia during the study;
  • Took drug from other research≤28 days prior to enrollment;
  • Any unstable cardiovascular diseases happened ≤6 months prior to enrollment, including but not limited to, unstable angina, myocardial infarction, heart failure (NYHA grade≥ III grade), severe arrhythmia that require drug interference, cardiac angioplasty/coronary stent implantation/ cardiac bypass surgery ≤6 months prior to enrollment;
  • Presence of central nervous system (CNS) disease or disease history, including epilepsy, cerebral ischemia/bleeding, dementia, cerebellar disease, or any autoimmune diseases that involve CNS;
  • Any other condition that researcher think it is inappropriate for the subject to anticipate the trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hongmei Jing, Doctor contact

15611908428

hongmei_jing@163.com

About this study

Official title: A Study of GC019F CAR-T Cell Immunotherapy for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of GC019F CAR-T cell immunotherapy in relapsed or refractory B-ALL. The study will include 6-12 subjects to receive GC019F therapy.

Read the detailed description

This study is an early, open, single-centered trial. The major aim of this study is to evaluate the safety and tolerance of GC019F CAR-T cell immunotherapy in relapsed or refractory B-ALL. The study will include 6-12 subjects to receive GC019F single infusion.

Being tested
GC019F
Medical subject headings
Burkitt Lymphoma

What participants receive

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

  • GC019FBiological

    GC019F is the CAR-T cell immunotherapy targeted CD19. The subjects will receive one single infusion of GC019F.

Study groups in NCT04595162
Study groupRoleWhat they receive
CAR-T treatment groupExperimentalThe patients will receive one dose of GC019F.
Receives: Biological: GC019F

What is being measured

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

  1. Incidence and severity of adverse events(AE)

    AEs will be collected and graded according to ASTCT consensus(for Cytokine Release Syndrome, CRS and Immune Effector Cell-Associated Neurotoxicity Syndrome, ICANS) and CTCAE v5.0(for AE except for CRS/ICANS )

    Measured: 15 years

Secondary outcomes (4)

  1. CAR copies and concentration of GC007F in peripheral blood, bone marrow and CSF

    GC007F CAR copies and cells in peripheral blood, bone marrow and CSF will be measured by qPCR and FCM in 2 years

    Measured: 2 years

  2. Overall response rate (ORR) and minimal residual disease negative (MRD-) rate of patients who received GC007F infusion

    ORR will be estimated as the percentage of patients who achieved CR or CRi. MRD- rate will be estimated as the percentage of patients who achieved MRD-(blast cells in bone marrow<10^-4 as determined by FCM).

    Measured: 2 years

  3. Duration of response (DOR), progression-free survival (PFS), overall survival (OS) of patients who received GC007F infusion

    DOR refers to the time interval from the date when the patient was evaluated as CR/CRi for the first time to the date when the patient was evaluated as disease relapse or death due to any reason. PFS refers to the time interval from the date of GC007F infusion to the date when the patient was evaluated as disease relapse or death due to any reason. OS refers to the time interval from the date of GC007F infusion to the date when the patient died due to any reason.

    Measured: 15 years

  4. Concentration of anti-GC007F antibody after infusion

    After GC007F infusion, GC007F antibody in peripheral blood will be measured in 2 years

    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 posted20 Oct 2020
  2. Study start15 Mar 2021 (estimated)
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion15 Dec 2035 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595162
Sponsor's protocol ID
PGC0005
Status last verified
Nov 2019
First submitted
14 Oct 2020
Last updated
20 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GC019F in people with B-cell Acute Lymphoblastic Leukemia, run by Peking University Third Hospital.

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 11 inclusion and 18 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: opening soon, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Hongmei Jing, Doctor (15611908428, hongmei_jing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events(AE) (time frame: 15 years). 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 NCT04595162.

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 20 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in