An interventional study of Autologous CD19 CAR-T cells in Pemphigus Vulgaris, sponsored by Jinbo Chen. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Jinbo Chen · Not applicable, Interventional, and Treatment
This is an investigator-initiated, single-center, single-arm, open-label exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T cell therapy in patients with refractory pemphigus vulgaris.
This is an investigator-initiated, open-label, single-center, single-arm exploratory interventional study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immune reconstitution, and preliminary clinical efficacy of autologous CD19 CAR-T cell therapy in adult patients with moderate-to-severe refractory pemphigus vulgaris.
Eligible participants are adults with refractory pemphigus vulgaris. After enrollment, participants will undergo leukapheresis for ex vivo manufacturing of autologous CD19 CAR-T cells. After product release, participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide within 2 to 7 days prior to CAR-T infusion.
Participants will receive a single intravenous infusion of autologous CD19 CAR-T cells at a protocol-defined dose (1 X 10\^6 CAR-positive T cells per kilogram of body weight). Premedication may be administered at investigator discretion. No comparator group is included.
Participants will be followed for up to 96 weeks after infusion. Safety assessments include monitoring for cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, infections, cytopenias, organ toxicities, and other treatment-emergent adverse events.
Efficacy assessments include changes in PDAI score, disease control, Physician Global Assessment (PGA), Autoimmune Bullous Skin Disorder Intensity Score (ABSIS), relapse rate, time to relapse, and corticosteroid-sparing effects.
Translational assessments include peripheral CD19-positive B-cell depletion and reconstitution, B-cell subset dynamics, serum anti-desmoglein 1 and 3 antibody levels, and serum cytokine profiles. CAR-T pharmacokinetics will be evaluated through CAR transgene copy number and circulating CAR-positive T-cell detection, including expansion and persistence metrics.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 3 is below the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →This is the only study on the registry with Jinbo Chen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Participants must meet all of the following criteria:
pemphigus vulgaris is defined as inadequate response, disease relapse, or treatment dependence following systemic and rituximab-based therapy for at least 6 months, with persistent disease activity meeting at least one of the following criteria:
Participants must have adequate organ function as defined below:
9. No evidence of clinically significant active infection at baseline evaluation.
10. Reproductive Criteria: Women of must have a negative serum beta-human chorionic gonadotropin (β-hCG) test within 48 hours prior to initiation of lymphodepleting chemotherapy. Women of childbearing potential must agree to use effective during study participation and for at least 12 months after CAR-T infusion. Male participants must agree to use effective contraception and avoid sperm donation during study participation and for at least 12 months after infusion.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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).
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.
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.
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.
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 US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
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 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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
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.
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.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
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.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with moderate-to-severe refractory pemphigus vulgaris will undergo leukapheresis for ex vivo manufacturing of autologous CD19 CAR-T cells. The CAR-T product is individually manufactured from each participant's own peripheral blood mononuclear cells and reinfused into the same participant; therefore, this is an autologous, patient-specific cellular therapy and not an allogeneic or off-the-shelf product. Following confirmation of product release, participants will receive protocol-defined lymphodepleting chemotherapy prior to CAR-T infusion, followed by a single intravenous infusion of autologous CD19 CAR-T cells. Participants will be monitored for safety, pharmacokinetics, pharmacodynamics, immune reconstitution, and preliminary clinical efficacy.
Biological: Autologous CD19 CAR-T cells
Autologous CD19 CAR-T cells are manufactured ex vivo using the participant's own T cells collected by leukapheresis. The CAR construct targets CD19-expressing B cells and consists of a single-chain variable fragment directed against CD19. Participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide prior to CAR-T cell infusion according to the protocol-defined schedule. Following completion of lymphodepletion, each participant will receive a single intravenous infusion of autologous CD19 CAR-T cells under inpatient monitoring. Premedication, including acetaminophen and diphenhydramine, may be administered prior to infusion at the investigator's discretion in accordance with institutional practice.
Incidence and Severity of Treatment-Emergent Adverse Events
Treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, infections, cytopenias, organ toxicities, infusion-related reactions, and clinically significant laboratory abnormalities will be assessed. Adverse events will be graded according to CTCAE v5.0, and immune effector cell-related toxicities will be assessed according to applicable consensus grading criteria.
Time frame: From initiation of lymphodepleting chemotherapy through Day 90 after CAR-T cell infusion
Change From Baseline in PDAI Score at Week 12
The change from baseline in Pemphigus Disease Area Index (PDAI) score at Week 12 will be assessed to evaluate preliminary clinical efficacy of autologous CD19 CAR-T cell therapy in patients with refractory pemphigus vulgaris.
Time frame: Baseline and Week 12
Proportion of participants achieving disease control at Week 4 after CAR-T infusion
Disease control is defined as cessation of new active cutaneous or mucosal lesions with established lesion healing or no further progression of existing lesions, as assessed by the investigator. This endpoint evaluates the early clinical response following CD19 CAR-T cell therapy and reflects initial disease stabilization after B-cell depletion.
Time frame: Week 4
Change From Baseline in Pemphigus Disease Area Index （PDAI） Score Over Time (Range 0-263)
Changes from baseline in Pemphigus Disease Area Index (PDAI) score will be assessed at scheduled follow-up visits to evaluate the durability of clinical response. The total PDAI score ranges from 0 to 263, with higher scores indicating more severe disease.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Change From Baseline in Physician Global Assessment Score (PGA) (Range 0-10)
Change from baseline in PGA score will be assessed at scheduled follow-up visits. PGA is a physician-rated global assessment of pemphigus disease severity, with higher scores indicating more severe disease activity.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Change from Baseline in Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) (Range 0-206)
Change from baseline in ABSIS will be assessed at scheduled follow-up visits. ABSIS is used to evaluate autoimmune bullous disease activity, with higher scores indicating more severe disease activity.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Proportion of participants achieving disease control at Week 12
Disease control is defined as cessation of new active cutaneous or mucosal lesions with healing or stabilization of existing lesions, as assessed by the investigator. This endpoint evaluates the durability and consolidation of clinical response following CD19 CAR-T cell therapy in patients with refractory pemphigus vulgaris.
Time frame: Week 12
Change From Baseline in Anti-Desmoglein 1 and Anti-Desmoglein 3 Antibody Levels
Serum anti-desmoglein 1 and anti-desmoglein 3 antibody levels will be measured to evaluate changes in pemphigus-related autoantibody responses after CD19 CAR-T cell therapy.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Peripheral CD19-Positive B-Cell Depletion and Reconstitution
Peripheral CD19-positive B-cell counts and B-cell subset dynamics will be assessed to evaluate the pharmacodynamic effect of CD19 CAR-T cell therapy, including B-cell depletion, time to B-cell aplasia, duration of B-cell depletion, and B-cell reconstitution.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Number of Circulating CAR-Positive T Cells in Peripheral Blood
The number of circulating CAR-positive T cells in peripheral blood will be measured by flow cytometry at scheduled time points after CAR-T cell infusion to assess in vivo CAR-T cell expansion.
Time frame: From CAR-T cell infusion through Week 96
CAR Transgene Copy Number in Peripheral Blood
CAR transgene copy number in peripheral blood will be measured by quantitative polymerase chain reaction or digital PCR at scheduled time points after CAR-T cell infusion to assess CAR-T cell expansion and persistence.
Time frame: From CAR-T cell infusion through Week 96
Duration of Detectable CAR-T Cells in Peripheral Blood
The duration of detectable CAR-T cells in peripheral blood will be assessed based on the time from CAR-T cell infusion to the last time point at which CAR-positive T cells or CAR transgene copies remain detectable.
Time frame: From CAR-T cell infusion through Week 96
Change From Baseline in Serum Cytokine Levels
Change from baseline in serum cytokine levels will be measured to characterize immune activation after CAR-T cell infusion and to support evaluation of cytokine release syndrome. Cytokines include interleukin-6 (IL-6), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), interleukin-2 (IL-2), interleukin-10 (IL-10), and interleukin-17A (IL-17A).
Time frame: Baseline through Week 96 after CAR-T cell infusion
Change From Baseline in Lymphocyte Subset Counts
Change from baseline in lymphocyte subset counts will be assessed at scheduled follow-up visits by flow cytometry to characterize immune reconstitution after CD19 CAR-T cell therapy. Lymphocyte subsets include CD3-positive T cells, CD4-positive T cells, CD8-positive T cells, CD19-positive B cells, and natural killer cells.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Change From Baseline in B-Cell Subset Counts
Change from baseline in B-cell subset counts will be assessed at scheduled follow-up visits by flow cytometry to characterize B-cell depletion and reconstitution after CD19 CAR-T cell therapy. B-cell subsets may include naïve B cells, non-switched memory B cells, switched memory B cells, and plasmablasts.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Relapse Rate Through Week 96
Relapse rate will be assessed as the proportion of participants who experience relapse after achieving disease control. Relapse is defined as the occurrence of three or more new lesions within one month that do not heal spontaneously within one week, or extension of established lesions.
Time frame: From disease control through Week 96 after CAR-T cell infusion
Time to First Relapse
Time to first relapse will be assessed as the time from achievement of disease control to the first documented relapse.
Time frame: From disease control through Week 96 after CAR-T cell infusion
Change From Baseline in Daily Prednisone-Equivalent Corticosteroid Dose
Change from baseline in daily systemic corticosteroid use will be assessed using prednisone-equivalent dose in milligrams per day at scheduled follow-up visits. A lower prednisone-equivalent daily dose indicates reduced corticosteroid requirement after CAR-T cell therapy.
Time frame: Baseline through Week 96 after CAR-T cell infusion
Incidence of Serious Adverse Events and Long-Term Safety Events
Serious adverse events, infections, prolonged cytopenias, organ dysfunction, secondary malignancies, and other clinically significant long-term safety events will be recorded throughout the study follow-up period.
Time frame: From informed consent through Week 96 after CAR-T cell infusion
Plan to share: No
No publications or documents are linked to this record.
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.
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.