An Early Phase 1 interventional study of GT801 Injection in B-cell Acute Lymphoblastic Leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL) and B-cell Non-Hodgkin's Lymphoma (B-NHL), sponsored by Grit Biotechnology. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Grit Biotechnology · Early Phase 1, Interventional, and Treatment
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Among 102 studies in Burkitt Lymphoma with a site in China — 58 open to participants now, 62 under way, 4 of them phase 3. Burkitt Lymphoma · China.
Among the 102 studies in Burkitt Lymphoma with a site in China, this one is the 43rd largest by planned enrollment of the 100 interventional ones that give a count, is one of 19 that started in 2025, is one of 53 in phase 1, reaches primary completion later than 36 of the 61 other live ones, and was the 87th registered.
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
Browse Burkitt Lymphoma studies →58 of the 102 studies in Burkitt Lymphoma with a site in China are open now. Recruiting first, the newest first:
Liping Dou · Sites in China
Ages 14–75
Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital · Sites in China
Ages 18–75
Ruijin Hospital · Sites in China
Ages 18–75
Beijing GoBroad Hospital · Sites in China
Ages 1–18
Beijing Biotech · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 128 Burkitt Lymphoma studies recruiting now, 38 (30%) set no upper age limit and 77 (60%) stop at 75 or younger; 75 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
102 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 74 · Phase 2 40 · Phase 3 6
First in 2011; this study’s year is marked. 19 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 28 is below the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Median enrollment 24 across the 100 interventional studies, 228 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 102 have an industry lead sponsor. The 10 most frequent:
Grit Biotechnology is the lead sponsor of 30 studies on the registry; 17 are open to participants now.
Grit Biotechnology has 1 study filed under Burkitt Lymphoma — fewer than ten, so there is no comparison to draw.
13 of the studies in Burkitt Lymphoma with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06927466Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia. | 2026-12-31 |
| NCT07575971Liping DouExploratory Study of CD22/CD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia | 2026-12-31 |
| NCT07575919Liping DouTargeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL | 2026-12-31 |
| NCT06580301Excyte Biopharma LtdStudy of YK012 in B-cell Acute Lymphoblastic Leukemia | 2026-12-31 |
| NCT05397496Novartis PharmaceuticalsStudy of PIT565 in Relapsed and/or Refractory B-cell Malignancies | 2027-01-04 |
Add all 13 to your calendar (.ics) → With an account.
Among the 102 studies in Burkitt Lymphoma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed/refractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia. Interim analysis conducted when 2 patients complete primary endpoint measurement.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For any prior systemic therapy (excluding ), an interval of at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed between the last dose of such therapy and the planned initiation of study treatment.
For any prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), an interval of at least 3 half-lives or 28 days (whichever is shorter) must have elapsed between the last dose of such treatment and the planned initiation of study treatment.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GT801 Injection
Biological: GT801 Injection
GT801 Injection
Proportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Time frame: 28 days
Incidence and severity of adverse events
Incidence and severity of adverse events per NCI-CTCAE version 5.0
Time frame: 3 months post GT801 infusion
3rd month Overall response rate (ORR) of hematological malignancy
The proportion of all evaluable subjects who were determined by the investigators to have achieved confirmed partial remission or complete remission at the third month after treatment initiation
Time frame: From the date of infusion to the 3rd month
Best Overall Response (BOR) of hematological malignancy
Best Overall Response (BOR) refers to the best therapeutic effect recorded from the start of treatment until disease progression or recurrence.
Time frame: Up to 12 months post infusion
Duration of Response (DoR) of hematological malignancy
To evaluate the duration from the date that criteria are met for complete response or partial response as assessed by the investigator until the date of disease progression or death due to any cause
Time frame: Up to 12 months post infusion
Progression-free survival (PFS) of hematological malignancy
To evaluate the time from the date of infusion to the date of disease progression as assessed by the investigator or the date of death due to any cause
Time frame: Up to 12 months post infusion
Overall survival (OS) of hematological malignancy
To evaluate the time from the date of infusion to the date of death due to any cause
Time frame: From the date of infusion to date of death due to any cause, or up to 12 months post infusion (whichever occurs first)
Overall response rate (ORR) of Autoimmune Hemolytic Anemia (AIHA)
To evaluate the percentage of participants who have a confirmed partial response or complete response among total number of evaluable participants as assessed by the investigator
Time frame: Up to 12 months post infusion
Complete Response Rate (CRR) of Autoimmune Hemolytic Anemia (AIHA)
Complete Remission Rate (CRR) refers to the proportion of evaluable subjects who achieve complete remission following post-treatment assessment.
Time frame: Up to 12 months post infusion
Partial Response Rate (PRR) of Autoimmune Hemolytic Anemia (AIHA)
Partial Remission Rate (PRR) refers to the proportion of evaluable subjects who achieve partial remission following post-treatment assessment.
Time frame: Up to 12 months post infusion
Disease-Free Recurrence (DFR) of Autoimmune Hemolytic Anemia (AIHA)
DFR refers to the state where complete remission of the disease is achieved after treatment, all relevant medications are successfully discontinued, and stable disease without recurrence is maintained for a certain period.
Time frame: Up to 12 months post infusion
Time to Response (TTR) of Autoimmune Hemolytic Anemia (AIHA)
TTR refers to the interval from the start of treatment to the first documentation of a participant achieving a predefined response.
Time frame: Up to 12 months post infusion
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Nov 2027, 26 months after the start.
Of 109 phase 1 interventional studies under Burkitt Lymphoma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 90. This study's planned 26 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: GT801