An interventional study of CHT105 in Immune Thrombocytopenia (ITP), sponsored by Nanjing Miracle Biotechnology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Nanjing Miracle Biotechnology Co., Ltd. · Not applicable, Interventional, and Treatment
Among 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China — 82 open to participants now, 92 under way, 12 of them phase 3. Purpura, Thrombocytopenic, Idiopathic · China.
Among the 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China, this one is the 132nd largest by planned enrollment of the 167 interventional ones that give a count, is one of 19 that started in 2026, is one of 13 with no phase, reaches primary completion later than 76 of the 91 other live ones, and was the 185th registered.
504 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 159 are open to participants now.
Browse Purpura, Thrombocytopenic, Idiopathic studies →82 of the 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China are open now. Recruiting first, the newest first:
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18–75
Hangzhou Sumgen Biotech Co., Ltd. · Sites in China
Ages 18–75
Chinese SLE Treatment And Research Group · Sites in China
Ages 18–65
Shandong University · Sites in China
Ages 18–80
The First Affiliated Hospital of Soochow University · Sites in China
Ages 18+
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 103 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 49 (48%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 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.
185 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 30 · Phase 2 79 · Phase 3 43 · Phase 4 16
First in 2005; this study’s year is marked. 19 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 58 across 377 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Median enrollment 62 across the 167 interventional studies, 400 across the 18 observational. Of the 44 that completed or were terminated, 8 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
49 of 185 have an industry lead sponsor. The 10 most frequent:
Nanjing Miracle Biotechnology Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Nanjing Miracle Biotechnology Co., Ltd. has 1 study filed under Purpura, Thrombocytopenic, Idiopathic — fewer than ten, so there is no comparison to draw.
26 of the studies in Purpura, Thrombocytopenic, Idiopathic with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06900920Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia | 2027-03 |
| NCT07559331Phase 3Shandong UniversityHigh-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia | 2027-04-08 |
| NCT07657793Phase 3Chinese SLE Treatment And Research GroupSirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia | 2027-09-30 |
| NCT04812925Phase 3argenxA Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | 2027-10 |
| NCT06107582Institute of Hematology & Blood Diseases Hospital, ChinaLongitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP) | 2026-12 |
Add all 26 to your calendar (.ics) → With an account.
Among the 185 studies in Purpura, Thrombocytopenic, Idiopathic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Primary Objective: To evaluate the safety and efficacy of CHT105 Injection in subjects with relapsed/refractory autoimmune diseases.
Secondary Objective:To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CHT105 Injection.
Indication: Immune Thrombocytopenia (ITP)
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.
1). Bone marrow function: a. ≥1×10⁹/L (no colony-stimulating factor therapy within 2 weeks prior to testing, except for neutropenia caused by underlying disease); b. ≥60 g/L; 2). Liver function: ≤3× (except for ALT elevation due to underlying disease); AST ≤3×ULN (except for AST elevation due to underlying disease); ≤1.5×ULN (except for TBIL elevation due to underlying disease); 3). Renal function: (CrCl) ≥30 mL/min (calculated by the Cockcroft-Gault formula, except for decreased CrCl caused by underlying disease); 4). Coagulation function: (INR) ≤1.5×ULN; Prothrombin Time (PT) ≤1.5×ULN; 5). Cardiac function: Good hemodynamic stability; 4.Female subjects of and male subjects with partners of child-bearing potential must use medically-accepted measures or practice abstinence during study treatment and for at least 6 months after the end of study treatment. Female subjects of child-bearing potential must have a negative serum HCG test result within 7 days prior to study enrollment and shall not be lactating; 5.Voluntarily participate in this clinical study, provide signed , have good compliance, and be willing to comply with follow-up procedures.
6.Diagnosed with immune thrombocytopenia (ITP) according to the 2009 International Working Group (IWG) consensus criteria; 7.latelet count \<50×10⁹/L on at least two consecutive occasions. In addition, peripheral blood smear findings shall support the diagnosis of ITP, with no evidence indicating alternative causes of thrombocytopenia (e.g., pseudothrombocytopenia, myelofibrosis). Physical examination findings shall reveal no diseases other than ITP that may cause thrombocytopenia; 8.Subjects shall have received one or more prior therapies for ITP (including but not limited to , immunoglobulins, azathioprine, danazol, cyclophosphamide and/or rituximab); 9.Subjects must have either a response to one prior ITP therapy ( count >50×10⁹/L) within the past 3 years, or bone marrow findings consistent with ITP, to rule out myelodysplastic syndrome (MDS) or other alternative causes of thrombocytopenia; 10.Subjects shall have Prothrombin Time (PT) not exceeding ±3 seconds relative to the normal reference range (or the International Normalized Ratio [INR] within 80%-120% of the normal range); activated partial thromboplastin time (aPTT) not exceeding ±10 seconds relative to the normal reference range; and no history of hypercoagulable state.
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Drug: CHT105
Single-dose administration and Multiple-dose administration, administered dose：2\*10\^8 CAR-T cells,6\*10\^8 CAR-T cells,1.8\*10\^9 CAR-T cells,3.6\*10\^9 CAR-T cells.
Types, severity, and frequency of adverse events (AEs)
Time frame: Throughout the study period, up to 52 weeks.
Complete response rate and partial response rate
Time frame: Week 12，Week 24
Peripheral blood CAR copy number
Time frame: Day 1,Day 4,Day 7,Day 10,Day 21
Peripheral blood lymphocyte subsets
Time frame: Day 1,Day 4,Day 7,Day 10,Week 2,Week 3,Week 4,Week 8,Week 12,Week 24,Week 36,Week 52
Autoantibodies
Time frame: Day 1,Day 7,Week 2,Week 3,Week 4,Week 8,Week 12,Week 24,Week 36,Week 52
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Purpura, Thrombocytopenic, Idiopathic →
Nanjing Miracle Biotechnology Co., Ltd.