B-cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT03825731
A Study of GC022 CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
A Early Phase 1 study testing GC022 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 GC022 CAR-T cell immunotherapy in relapsed or refractory B-ALL. The investigators plan to include 20 subjects to receive GC022 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?
- GC022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2019to 16 Sep 2019
- 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
- Relapsed or refractory paediatric B-cell ALL 1) 2nd or greater bone marrow (BM) relapse or 2) Relapse after remission for the first time in 12 months or 3) The interval between relapse after allogeneic hematopoietic stem cell transplantation and CAR-T cells transfusion≥100 days or 4) Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukaemia or 5) Patients with Philadelphia chromosome positive ALL were eligible if they were intolerant to or had failed two lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy was contraindicated or 6) Ineligible for allogeneic SCT because of: i. Comorbid disease ii. Other contraindications to allogeneic SCT conditioning regimen iii. Lack of suitable donor iv. Prior SCT v. Declined allogeneic SCT as a therapeutic option after documented discussion, including expected outcomes, about the role of SCT with a BM transplantation physician not part of the study team
- For relapsed patients, CD19 tumour expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry
- Aged 2-70 years
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- Life expectancy≥12 weeks
- Adequate organ function defined as:1) Creatinine clearance (as estimated by Cockcroft Gault) >60 mL/min. 2) Serum ALT/AST<2.5 ULN. 3) Total bilirubin<1.5 mg/dl, except in subjects with Gilbert's syndrome. 4) Cardiac ejection fraction≥45%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings. 5) No clinically significant pleural effusion. 6) Baseline oxygen saturation >92% on room air. 7) pulmonary function: ventilation function is normal or is restricted mildly.
- 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 6 months after cell transfusion therapy.
- The subject agree 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;
- Patients with Burkitt's lymphoma/leukaemia;
- Central nervous system leukemia involved CNS3;
- Concomitant malignancy other than non-melanoma skin cancer or adequately-treated cervical carcinoma in situ or prostate cancer (PSA score<1.0) or adequately-treated low grade bladder cancer or surgery-cured ductal carcinoma in situ or diagnosis of other malignancy exceeds 5 years without relapse or treatment during the 5 years;
- Concomitant genetic diseases except Down syndrome;
- Any result of the following virology tests is positive: HIV; HCV; HBsAg; or HBCAb positive with HBV DNA copies positive(≥ 5×10^2 copies/ml); RPR+TPPA postive;
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- Live vaccine ≤4 weeks prior to apheresis;
- Presence of grade 2 to 4 graft-versus-host disease (GVHD) after allo-HSCT;
- The following medications were excluded: 1) Steroids: Therapeutic systemic doses of steroids must be stopped >72 hours prior to tisagenlecleucel infusion. However, the following physiological replacement doses of steroids are allowed: <12 mg/m^2/day hydrocortisone or equivalent; 2) Allogeneic cellular therapy: Any donor lymphocyte infusions must be completed >6 weeks prior to tisagenlecleucel infusion; 3) GVHD therapies: Any systemic drug used for GVHD must be stopped >4 weeks prior to infusion to confirm that GVHD recurrence is not observed;
- Preventive treatments of CNS diseases must be stopped >3 days prior to infusion (e.g., intrathecal injection of methotrexate) 1) Radiotherapy of non-CNS nidus must be completed >2 weeks prior to infusion; 2) CNS stereotactic radiotherapy must be completed >8 weeks prior to infusion;
- ≥2 grade toxicities related to previous therapy are not relieved, with the exception of adverse events without security risk (e.g., alopecia);
- Known life-threatening allergy, hypersensitivity or intolerance to GC022 cells and adjuvant, including DMSO (see investigator's brochure);
- Patients with active autoimmune disease (e.g., systemic lupus erythematosus, sjogren syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease) receive immunosuppressive therapy in 4 weeks before inclusion. thyroid hormone replacement therapy is an exception;
- For patients that underwent major surgical operation before CAR-T treatment, or anticipated to undergo a major surgical operation during the study process, they need to be fully recovered and clinically stable before inclusion.
- Participate in other clinical trial and received study drugs <28 days prior to inclusion;
- Concomitant disease that may or severe medical condition that may affect patients' safety, including active viral or bacterial infection, uncontrollable systemic fungal infection, uncontrollable cardiac disease, hypertension, abuse of psychoactive drugs, et al.
- Any other condition that may increase subjects' risk or interfere with trial's results.
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, Peihua_lu@126.com
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 GC022 CAR-T cell immunotherapy in relapsed or refractory B-ALL. The investigators plan to include 20 subjects to receive GC022 therapy.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- GC022
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC022Biological
GC022 is a bispecific CAR-T cell immunotherapy that targeted CD19 and CD22. The subjects will receive one dose of GC022 infusion. The dosage ranges from 3×10^5 to 1×10^7 CAR+T/Kg.
| Study group | Role | What they receive |
|---|---|---|
| GC022 | Experimental | The patients will receive GC022 CAR-T treatment. GC022 dosage ranges from 3×10^5 to 1×10^7 CAR+T/Kg. Receives: Biological: GC022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Dose Limiting Toxicity
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GC022 cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5
Measured: 12 weeks
Incidence of adverse events
After GC022 infusion, adverse events will be graded as CTCAE 4.0
Measured: 12 weeks
GC022 persistence
After GC022 infusion, GC022 CAR copies in peripheral blood. bone marrow and CSF will be measured by qPCR in 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
Percents of Patients with best response as complete remission and MRD negative complete remission
Response rates will be estimated as the percents of patients whose best response is complete remission and MRD negative complete remission
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start17 Jan 2019
- Primary completion16 Sep 2019 (estimated)
- Study completion16 Sep 2019 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnology Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825731
- Sponsor's protocol ID
- PGC0003
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of GC022 CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
- ClinicalTrials.gov ID
- NCT03825731
- Acronym / sponsor ID
- PGC0003
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Collaborators
- Gracell Biotechnology Ltd.
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 16 Sep 2019 (estimated)
- Study completion
- 16 Sep 2019 (estimated)
- First posted
- 31 Jan 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 GC022 CAR-T cell immunotherapy in relapsed or refractory B-ALL. The investigators plan to include 20 subjects to receive GC022 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC022 | Experimental | Biological: GC022The patients will receive GC022 CAR-T treatment. GC022 dosage ranges from 3×10^5 to 1×10^7 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 (8 listed)
- Relapsed or refractory paediatric B-cell ALL 1) 2nd or greater bone marrow (BM) relapse or 2) Relapse after remission for the first time in 12 months or 3) The interval between relapse after allogeneic hematopoietic stem cell transplantation and CAR-T cells transfusion≥100 days or 4) Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukaemia or 5) Patients with Philadelphia chromosome positive ALL were eligible if they were intolerant to or had failed two lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy was contraindicated or 6) Ineligible for allogeneic SCT because of: i. Comorbid disease ii. Other contraindications to allogeneic SCT conditioning regimen iii. Lack of suitable donor iv. Prior SCT v. Declined allogeneic SCT as a therapeutic option after documented discussion, including expected outcomes, about the role of SCT with a BM transplantation physician not part of the study team
- For relapsed patients, CD19 tumour expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry
- Aged 2-70 years
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- Life expectancy≥12 weeks
Key exclusion criteria (17 listed)
- Isolated extra-medullary disease relapse;
- Patients with Burkitt's lymphoma/leukaemia;
- Central nervous system leukemia involved CNS3;
- Concomitant malignancy other than non-melanoma skin cancer or adequately-treated cervical carcinoma in situ or prostate cancer (PSA score<1.0) or adequately-treated low grade bladder cancer or surgery-cured ductal carcinoma in situ or diagnosis of other malignancy exceeds 5 years without relapse or treatment during the 5 years;
- Concomitant genetic diseases except Down syndrome;
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 |
|---|---|---|
| GC022GC022 is a bispecific CAR-T cell immunotherapy that targeted CD19 and CD22. The subjects will receive one dose of GC022 infusion. The dosage ranges from 3×10^5 to 1×10^7 CAR+T/Kg. | Biological | GC022 |
Primary outcome
Number of Patients with Dose Limiting Toxicity
Time frame: 12 weeks
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GC022 cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5
Incidence of adverse events
Time frame: 12 weeks
After GC022 infusion, adverse events will be graded as CTCAE 4.0
GC022 persistence
Time frame: 12 weeks
After GC022 infusion, GC022 CAR copies in peripheral blood. bone marrow and CSF will be measured by qPCR in 12 weeks
1 secondary outcome
Percents of Patients with best response as complete remission and MRD negative complete remission
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: No
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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.
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 GC022 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 8 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 31 Jan 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Dose Limiting Toxicity (time frame: 12 weeks). 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?
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 31 Jan 2019.