B-cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT04129099
A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
A Early Phase 1 study testing GC022F in people with B-cell Acute Lymphoblastic Leukemia, run by Hebei Yanda Ludaopei Hospital at 1 site in China.
Trial summary
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of GC022F CAR-T cell immunotherapy in relapsed or refractory B-ALL. The study will include 18 subjects to receive GC022F therapy. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- GC022F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2019to Jun 2022
- Phase
- Early 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 2-70 years;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2;
- Life expectancy≥12 weeks;
- CD19 and/or CD22 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry;
- Relapsed or refractory B- ALL: a) Refractory B- ALL: MRD≥0.1% or 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 MRD≥0.1% or 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; Relapse is defined as above; 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;
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- Adequate organ function defined as: a) Creatinine clearance (as estimated by Cockcroft Gault) >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 period of trial and in 2 years after cell transfusion therapy; 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, willing and able to comply with the planned visit, research, treatment planning, laboratory and other test procedures.
Who cannot join
- Isolated extra-medullary disease relapse;
- Central nervous system leukemia involved CNS-3;
- 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 virology 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 weeks prior to enrollment;
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- 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, surgical operation 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 during the study;
- 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, any autoimmune diseases that involve CNS;
- Presence of active infection that require therapy ≤2 weeks prior to apheresis;
- Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, 065200
Peihua Lu, PhD&MD, +86-0316-3306393
About this study
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of GC022F CAR-T cell immunotherapy in relapsed or refractory B-ALL. The study will include 18 subjects to receive GC022F therapy.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- GC022F
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC022FBiological
GC022F is the CAR-T cell immunotherapy targeted CD19 and CD22. The subjects will receive GC022F as one dose. The dosage ranges from 6×10^4 to 1.5×10^5 CAR+T/Kg.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment group | Experimental | The patients will receive one dose of GC022F. GC022F dosage ranges from 6×10^4 to 1.5×10^5 CAR+T/Kg. Receives: Biological: GC022F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment related Adverse Events, CRS and Neurotoxicity (Safety and tolerability)
Adverse events(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 CRS/ICANS )
Measured: 2 years
Secondary outcomes (3)
CAR copies and concentration of GC022F in peripheral blood, bone marrow and CSF (amplification and persistence)
GC022F CAR copies and cells in peripheral blood, bone marrow and CSF will be measured by qPCR and FCM in 2 years
Measured: 2 years
Overall response rate of patients who received GC022F infusion (efficacy)
Overall response rate will be estimated as the percents of patients who achieved CR or CRi.
Measured: 2 years
Concentraiton of anti-GC022F antibody after infusion (humoral immune response)
After GC022F infusion, GC022F 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.
- First posted16 Oct 2019
- Study start22 Oct 2019
- Primary completionSep 2020 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnology Ltd., Beijing Lu Daopei Hospital
- Responsible party
- Sponsor
- Investigators
- Junfang Yang, Bachelor, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129099
- Sponsor's protocol ID
- PGC0006
- Status last verified
- May 2020
- First submitted
- 15 Oct 2019
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
- ClinicalTrials.gov ID
- NCT04129099
- Acronym / sponsor ID
- PGC0006
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Collaborators
- Gracell Biotechnology Ltd., Beijing Lu Daopei Hospital
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of GC022F CAR-T cell immunotherapy in relapsed or refractory B-ALL. The study will include 18 subjects to receive GC022F therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment group | Experimental | Biological: GC022FThe patients will receive one dose of GC022F. GC022F dosage ranges from 6×10^4 to 1.5×10^5 CAR+T/Kg. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 2-70 years;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2;
- Life expectancy≥12 weeks;
- CD19 and/or CD22 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry;
- Relapsed or refractory B- ALL: a) Refractory B- ALL: MRD≥0.1% or 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 MRD≥0.1% or 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; Relapse is defined as above; 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.
Key exclusion criteria (18 listed)
- Isolated extra-medullary disease relapse;
- Central nervous system leukemia involved CNS-3;
- 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 virology tests is positive: HIV; HCV; HBsAg; or HBCAb positive with HBV DNA copies positive; TPPA;
- Live vaccine ≤4 weeks prior to enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC022FGC022F is the CAR-T cell immunotherapy targeted CD19 and CD22. The subjects will receive GC022F as one dose. The dosage ranges from 6×10^4 to 1.5×10^5 CAR+T/Kg. | Biological | CAR-T treatment group |
Primary outcome
Incidence and severity of treatment related Adverse Events, CRS and Neurotoxicity (Safety and tolerability)
Time frame: 2 years
Adverse events(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 CRS/ICANS )
3 secondary outcomes
CAR copies and concentration of GC022F in peripheral blood, bone marrow and CSF (amplification and persistence)
Time frame: 2 years
Overall response rate of patients who received GC022F infusion (efficacy)
Time frame: 2 years
Concentraiton of anti-GC022F antibody after infusion (humoral immune response)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junfang Yang, Bachelor principal investigator
Hebei Yanda Ludaopei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GC022F in people with B-cell Acute Lymphoblastic Leukemia, run by Hebei Yanda Ludaopei 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 10 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: status not confirmed, as of the sponsor's last update on 28 May 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Junfang Yang, Bachelor (13522084342, Yangjunfang77@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 treatment related Adverse Events, CRS and Neurotoxicity (Safety and tolerability) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2020.