An interventional study of BCT301 Cell Injection in IgG4-related Disease, sponsored by Peking University Third Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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This is an investigator initiated trial to assess the safety and efficacy of BCT301 cell Injection (CAR-iT cells derived from chemically induced pluripotent stem cells) in patients with refractory/recurrent IgG4-related disease.
This is a single-arm, open-label, single-center clinical study in which all patients receive a unified treatment regimen. The primary objective is to evaluate the safety and tolerability of BCT301 Cell Injection in patients with refractory/recurrent IgG4-RD. Secondary objective is to evaluate the improvement in disease activity in patients with refractory/recurrent IgG4-RD treated with BCT301 Cell Injection. Six subjects with refractory/recurrent IgG4-RD meeting the inclusion/exclusion criteria are planned to be enrolled and will receive a single infusion of 1.8 × 10\^8 BCT301 Cell Injection to evaluate the safety, efficacy, and PK/PD characteristics following BCT301 Cell Injection infusion. The study flow consists of a screening period, a lymphodepletion pretreatment period, a treatment period, and a follow-up period. Patients without relapse or deterioration after BCT301 Cell Injection infusion and not requiring protocol-prohibited treatment will undergo a primary follow-up of up to 360 days.
72 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 40 are open to participants now.
This study's planned enrollment of 6 is below the median of 48 across 52 interventional studies indexed under Immunoglobulin G4-Related Disease.
Browse Immunoglobulin G4-Related Disease studies →Peking University Third Hospital is the lead sponsor of 755 studies on the registry; 276 are open to participants now.
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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.
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.
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.
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.
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.
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.
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
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.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: BCT301 Cell Injection
BCT301 Cell Injection are CAR-iT cells derived from chemically induced pluripotent stem cells. Six subjects with refractory/recurrent IgG4-RD meeting the inclusion/exclusion criteria are planned to be enrolled and will receive a single infusion of 1.8 × 10\^8 BCT301 Cell Injection to evaluate the safety, efficacy, and PK/PD characteristics following BCT301 Cell Injection infusion.
The safety and tolerability of BCT301 Cell Injection in patients with refractory/recurrent IgG4-RD.
The occurrence of cell-infusion-related adverse events within 28 days after BCT301 Cell Injection infusion, with special emphasis on cell-therapy-specific adverse reactions such as CRS and ICANS.
Time frame: 28 days after BCT301 Cell Injection infusion
The change in IgG4-RD RI from baseline at 180 days after BCT301 Cell Injection infusion.
This endpoint evaluates the absolute change in the IgG4-Related Disease Responder Index (IgG4-RD RI) score from baseline to Day 180 post-infusion. The IgG4-RD RI is a validated, disease-specific composite scoring system that quantifies organ involvement and disease activity across multiple domains (e.g., head/neck, chest, retroperitoneum, etc.). The change is calculated as the Day 180 score minus the baseline score; a negative value indicates improvement (reduction in disease activity), while a positive value indicates worsening. This continuous variable complements the binary response rate endpoint by providing a more granular assessment of the degree of clinical improvement or deterioration over time, and will be analyzed using descriptive statistics (mean, median, standard deviation) as well as inferential tests (e.g., paired t-test or Wilcoxon signed-rank test) for within-subject change.
Time frame: 180 days after BCT301 Cell Injection infusion.
IgG4-RD RI response rate (decrease ≥ 2 points from baseline) at 90 and 180 days after BCT301 Cell Injection infusion.
This endpoint measures the proportion of subjects achieving at least a 2-point reduction from baseline in the IgG4-Related Disease Responder Index (IgG4-RD RI) at Day 90 and Day 180 post-infusion. The IgG4-RD RI is a validated disease activity scoring system; a decrease of ≥2 points is considered clinically meaningful and indicates a partial response to treatment.
Time frame: 90, 180 days after BCT301 Cell Injection infusion.
IgG4-RD complete remission rate at 180 and 360 days after BCT301 Cell Injection infusion.
This endpoint evaluates the proportion of subjects who achieve stringent complete remission at Day 180 and Day 360. Complete remission requires all three criteria to be met simultaneously: (1) IgG4-RD RI score of 0 (no active disease manifestations); (2) prednisone dose of 0 mg/day after Week 4 (excluding any short-term glucocorticoid pulse used specifically to manage cytokine release syndrome \[CRS\] or allogeneic immune reactions, which are not counted as maintenance therapy); and (3) no documented recurrence or flare of disease activity from baseline through the assessment time point.
Time frame: 180 and 360 days after BCT301 Cell Injection infusion.
Proportion of patients with relapse after remission at 90, 180, and 360 days after BCT301 Cell Injection infusion.
This endpoint measures the cumulative proportion of subjects who, having achieved any remission (partial or complete) after infusion, subsequently experience disease relapse at Day 90, Day 180, or Day 360. Relapse is specifically defined as an increase in IgG4-RD RI score during the follow-up period that necessitates additional therapeutic intervention not specified in the study protocol, thereby indicating loss of disease control.
Time frame: 90, 180, and 360 days after BCT301 Cell Injection infusion.
Changes in IgG4 levels at 90, 180, and 360 days after BCT301 Cell Injection infusion.
This endpoint assesses the absolute change from baseline in serum IgG4 concentration (measured in g/L) at Day 90, Day 180, and Day 360 post-infusion.
Time frame: 90, 180, and 360 days after BCT301 Cell Injection infusion.
Physician Global Assessment (PhGA) and Patient Global Assessment (PtGA) compared with baseline.
This endpoint evaluates the change from baseline in both the Physician Global Assessment (PhGA) and the Patient Global Assessment (PtGA), each measured using a single-item visual analogue scale (VAS) ranging from 0 to 100 mm, where 0 indicates no disease activity and 100 indicates the worst possible disease activity/symptoms. Higher scores indicate a worse outcome. Changes are assessed at predefined time points (consistent with other endpoints, e.g., 90, 180, and 360 days) to capture the treatment effect from both clinician and patient perspectives.
Time frame: 90, 180, and 360 days after BCT301 Cell Injection infusion.
CAR gene copy number in peripheral blood after BCT301 Cell Injection infusion and the duration of persistence after infusion.
This endpoint quantifies the level of CAR transgene in peripheral blood using a validated quantitative polymerase chain reaction (qPCR) assay specific to the CAR construct. CAR gene copy number is measured at baseline and at multiple post-infusion time points: Days 1, 3, 7, 10, 14, 28, 90. Results are expressed as copies per microgram of genomic DNA or copies per milliliter of blood. The persistence duration is defined as the last time point at which the CAR copy number remains above the lower limit of quantification for each subject.
Time frame: Days 0, 1, 3, 7, 10, 14, 28, 90.
Time to maximum concentration (Tmax) of CAR gene copies after BCT301 Cell Injection infusion.
This PK parameter is derived from the CAR gene copy number-time profile. Tmax is defined as the time (in days) from the end of BCT301 infusion to the first occurrence of the peak CAR copy number (Cmax) in peripheral blood. It is estimated using non-compartmental analysis based on serial measurements collected during the early post-infusion period (Days 1, 3, 7, 10, 14, and 28). Tmax reflects the kinetics of CAR-T cell expansion and trafficking to the peripheral circulation.
Time frame: Days 0, 1, 3, 7, 10, 14, 28, 90.
Maximum concentration (Cmax) of CAR gene copies after BCT301 Cell Injection infusion.
This PK parameter represents the peak observed CAR gene copy number in peripheral blood after infusion. Cmax is determined directly from the concentration-time data as the highest measured value ( copies/mL) during sampling period. It quantifies the maximal expansion level of the infused CAR-T cells and is a key exposure metric for correlating with efficacy and toxicity.
Time frame: Days 0, 1, 3, 7,10, 14, 28, 90.
Area under the concentration-time curve from 0 to 28 days (AUC28) of CAR gene copies after BCT301 Cell Injection infusion.
AUC28 is the integral of the CAR gene copy number-time curve from the time of infusion (Day 0) to Day 28, calculated using the linear trapezoidal rule (or log-linear for descending part). It quantifies the total early systemic exposure to CAR-T cells over the first 28 days, capturing the initial expansion and contraction phase. Missing intermediate values are handled by standard PK imputation methods. AUC28 is expressed as copies·day/mL.
Time frame: Days 0, 1, 3, 7, 10, 14, 28.
Area under the concentration-time curve from 0 to 90 days (AUC90) of CAR gene copies after BCT301 Cell Injection infusion.
AUC90 is the integral of the CAR gene copy number-time curve from the time of infusion to Day 90, calculated using the same non-compartmental method. It reflects the total exposure over a longer period that includes both early expansion and subsequent persistence/clearance. This parameter provides additional information on the durability of CAR-T cell persistence beyond the initial month and may better correlate with sustained pharmacodynamic effects. Measurements from Days 0, 1, 3, 7, 10, 14, 28, and 90 are used for calculation.
Time frame: Days 0, 1, 3, 7, 10, 14, 28, and 90.
The PD characteristics of B-cell count in peripheral blood after BCT301 Cell Injection infusion.
This endpoint evaluates the pharmacodynamic (PD) effect of BCT301 Cell Injection on B-cell lineage in the peripheral blood. Absolute B-cell counts (cells/µL) are measured by flow cytometry using CD19⁺ (or CD20⁺) gating at scheduled post-infusion time points (including 0-28 days, 90, 180, and 360 days). Changes from baseline in B-cell count are calculated to assess the extent and duration of B-cell depletion or modulation induced by the CAR-T therapy. The count is expressed as absolute number per microliter, and both raw values and percentage change from baseline will be summarized descriptively.
Time frame: 0-28 days, 90, 180, and 360 days after BCT301 Cell Injection infusion.
Cytokine changes following BCT301 infusion.
This endpoint measures serial changes in serum/plasma concentrations of six pro-inflammatory and immunomodulatory cytokines (IL-6, IL-10, IL-2, IL-8, TNF-α, and IFN-γ) following BCT301 infusion. Cytokine levels are quantified using a validated multiplex immunoassay (e.g., Luminex or electrochemiluminescence) at baseline and at multiple post-infusion time points (0-28 days, 90, 180, and 360 days). For each cytokine, the absolute change and percentage change from baseline are calculated. These data are used to monitor cytokine release syndrome (CRS) risk and to explore the relationship between cytokine dynamics and clinical efficacy/toxicity.
Time frame: 0-28 days, 90, 180, and 360 days after BCT301 infusion.
B-cell subset changes following BCT301 Cell Injection infusion.
This endpoint evaluates the phenotypic redistribution of B-cell subpopulations in peripheral blood after BCT301 infusion. Using multicolor flow cytometry with defined gating strategies, the following proportional measures are derived at baseline and at post-infusion time points (0-28 days, 90, 180, and 360 days): (1) total B cells as % of lymphocytes (CD19⁺ or CD20⁺); (2) naive B cells (CD19⁺CD27-IgD⁺) as % of B cells; (3) memory B cells (CD19⁺CD27⁺) as % of B cells; (4) class-switched memory B cells (CD19⁺CD27⁺IgD-) as % of B cells; (5) unswitched memory B cells (CD19⁺CD27⁺IgD⁺) as % of B cells; (6) plasmablasts (CD19⁺CD38⁺CD27⁺) as % of B cells; and (7) immature/transitional B cells (CD19⁺CD20⁺CD21-CD27-) as % of CD19⁺CD20⁺ cells. Changes from baseline for each subset proportion are calculated to assess the impact of CAR-T therapy on B-cell maturation and reconstitution, which may correlate with humoral immune recovery and long-term disease control.
Time frame: 0-28 days, 90, 180, and 360 days after BCT301 Cell Injection infusion.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Immunoglobulin G4-Related Disease →
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