Large-cell LymphomaPhase 1NCT07443137
CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)
A Phase 1 study testing Rapcabtagene autoleucel (YTB323) in people with Large-cell Lymphoma, run by Stanford University at 1 site in United States.
Trial summary
This is a phase 1b clinical trial to assess the efficacy of rapcabtagene autoleucel (YTB323) administered at the recommended dose in adults with Large B Cell Lymphoma (LBCL) who are at high risk of relapse at end of first line treatment (EOT), as defined by positive measurable residual disease detected by Foresight… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large-cell Lymphoma
- What is being tested?
- Rapcabtagene autoleucel (YTB323)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility for Pre-Screening:
- Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2022[1]:
- Diffuse large B cell lymphoma (DLBCL); OR
- Primary mediastinal (thymic) large B cell lymphoma; OR
- Transformation of indolent lymphomas (eg follicular lymphoma or marginal zone lymphoma)to DLBCL; OR
- High grade B-cell Lymphoma (NOS, or with MYC/BCL2 rearrangements);
Show all 34Show fewer
- Double hit lymphoma (DHL) / Triple hit lymphoma (THL); OR
- Follicular lymphoma grade 3b
- Must have 10 unstained slides or tissue block from lymph node excision or core needle biopsy, or a lymph node biopsy (NOT FNA, bone or bone marrow biopsy), in 5 µm thickness FFPE with H\&E slide available for ctDNA calibration.
- Must have intention to complete frontline chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.
- In the investigator's assessment, is likely to be eligible to proceed to the treatment portion of this study with intention to undergo YTB323 if MRD positive.
- Must be able to understand and the willingness to sign the written IRB approved pre-screening informed consent document.
- Eligibility Criteria for Screening
- 1. Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2022[1]:
- Diffuse large B cell lymphoma (DLBCL); OR
- Primary mediastinal (thymic) large B cell lymphoma; OR
- Transformation of indolent lymphomas to DLBCL; OR
- High grade B-cell Lymphoma;
- Double hit lymphoma (DHL) / Triple hit lymphoma (THL); OR
- Follicular lymphoma grade 3b
- 2. Must have completed planned frontline chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline based therapy for LBCL indication with a CR or PR inaccessible for biopsy at end of treatment (EOT 1L).
- 3. Circulating tumor DNA is detectable by PhasED-seq within 12 weeks after completion of standard chemoimmunotherapy.
- 6. Normal Organ and Marrow Function
- ANC ≥ 1,000/uL
- Platelet count ≥ 75,000/uL
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL/min
- Serum ALT or AST ≤ 5 x ULN (except in subjects with liver involvement by lymphoma)
- Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome.
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.
- No clinically significant pleural effusion or ascites
- Baseline oxygen saturation > 92% on room air 7. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) 8. Contraception: Subjects of child bearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study and for twelve (12) months after receiving the preparative lymphodepletion regimen.
- 9. Must be able to understand and the willingness to sign the written IRB approved informed consent document. Subjects unable to give informed consent will not be eligible for this study.
- 4. Age 18 years or older 5. Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2.
Who cannot join
- 1. Prior treatment with CAR-T or adoptive cell therapy 2. Prior allogeneic transplant. 3. No bridging therapy permitted. 4. Active central nervous system disease from lymphoma. MRI of the brain with no evidence of CNS lymphoma if prior history of CNS involvement.
- 5. Prior history of allergic reactions to any of the reagents used in the rapcabtagene autoleucel infusion.
- 6. History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
- 7. History of T-cell histiocyte-rich large B-cell lymphoma. 8. Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment.
- 9. Women who are pregnant or breastfeeding 10. History of invasive malignancy unless the patient has been disease-free for two years.
- Exceptions include nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, and breast) and low grade prostate cancer (e.g. Gleason 3+3) Hormonal therapy in subjects in remission >1 year will be allowed. 11. History of stroke or transient ischemic attack within 12 months before enrollment, or seizure disorders requiring active anticonvulsive medication.
- 12. In the investigator's judgment, the subject is unlikely to complete all study-specific visits or procedures, including follow-up visits, or comply with the study requirements for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Sunny Salazar, 650-725-7540, sunnysw@stanford.edu
Saurabh Dahiya
About this study
Official title: Rapcabtagene Autoleucel for Eradication of Measurable Residual Disease in Large B-Cell Lymphoma (LBCL)
This is a phase 1b clinical trial to assess the efficacy of rapcabtagene autoleucel (YTB323) administered at the recommended dose in adults with Large B Cell Lymphoma (LBCL) who are at high risk of relapse at end of first line treatment (EOT), as defined by positive measurable residual disease detected by Foresight CLARITY (PhasED-seq). Participants will initially be pre-screened for MRD status after first line treatment (1L) with chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.
- Conditions
- Large-cell Lymphoma
- Being tested
- Rapcabtagene autoleucel (YTB323)
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapcabtagene autoleucel (YTB323)Biological
Autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy manufactured from participant-derived T cells. Participants undergo leukapheresis for cell collection, receive lymphodepleting chemotherapy, followed by a single intravenous infusion of rapcabtagene autoleucel (YTB323).
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort (MRD-Negative) | No intervention | Participants who are minimal residual disease (MRD) negative following frontline therapy will not receive study intervention and will be followed for subsequent treatments, response, disease status, and survival. |
| Rapcabtagene Autoleucel (YTB323) Treatment Cohort | Experimental | Participants who are MRD-positive following frontline therapy and meet eligibility criteria will undergo leukapheresis, lymphodepleting chemotherapy, and infusion of rapcabtagene autoleucel (YTB323). Participants will be followed for MRD conversion, safety, disease status, survival, and long-term gene therapy follow-up. Receives: Biological: Rapcabtagene autoleucel (YTB323) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Residual Disease (MRD) Conversion Rate at Day 90
Proportion of participants who achieve conversion from MRD-positive status at baseline to MRD-negative status at Day 90 (± 2 weeks) following infusion of rapcabtagene autoleucel (YTB323).
Measured: Day 90 (3 months ± 2 weeks) post-infusion
Secondary outcomes (3)
Progression free survival
Progression free survival (PFS) at 12 months from study treatment infusion as compared to historic controls (approximately 18 months from start of frontline therapy).
Measured: 12 months
Incidence of Adverse Events
Number of participants experiencing treatment-emergent adverse events following infusion of rapcabtagene autoleucel (YTB323), graded according to CTCAE criteria.
Measured: From infusion through Day 28 post-infusion
Incidence of Dose-Limiting Toxicities (DLTs)
Number of participants experiencing dose-limiting toxicities (DLTs) following infusion of rapcabtagene autoleucel (YTB323), as defined per protocol.
Measured: From infusion through Day 28 post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start15 Sep 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Saurabh Dahiya, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443137
- Sponsor's protocol ID
- IRB-78752
- Other IDs
- NCI-2026-03512
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapcabtagene Autoleucel for Eradication of Measurable Residual Disease in Large B-Cell Lymphoma (LBCL)
- ClinicalTrials.gov ID
- NCT07443137
- Acronym / sponsor ID
- IRB-78752
- Conditions
- Large-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1b clinical trial to assess the efficacy of rapcabtagene autoleucel (YTB323) administered at the recommended dose in adults with Large B Cell Lymphoma (LBCL) who are at high risk of relapse at end of first line treatment (EOT), as defined by positive measurable residual disease detected by Foresight CLARITY (PhasED-seq). Participants will initially be pre-screened for MRD status after first line treatment (1L) with chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort (MRD-Negative) | No intervention | –Participants who are minimal residual disease (MRD) negative following frontline therapy will not receive study intervention and will be followed for subsequent treatments, response, disease status, and survival. |
| Rapcabtagene Autoleucel (YTB323) Treatment Cohort | Experimental | Biological: Rapcabtagene autoleucel (YTB323)Participants who are MRD-positive following frontline therapy and meet eligibility criteria will undergo leukapheresis, lymphodepleting chemotherapy, and infusion of rapcabtagene autoleucel (YTB323). Participants will be followed for MRD conversion, safety, disease status, survival, and long-term gene therapy follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2022[1]:
- Must have 10 unstained slides or tissue block from lymph node excision or core needle biopsy, or a lymph node biopsy (NOT FNA, bone or bone marrow biopsy), in 5 µm thickness FFPE with H\&E slide available for ctDNA calibration.
- Must have intention to complete frontline chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.
- In the investigator's assessment, is likely to be eligible to proceed to the treatment portion of this study with intention to undergo YTB323 if MRD positive.
- Must be able to understand and the willingness to sign the written IRB approved pre-screening informed consent document.
Key exclusion criteria (7 listed)
- 1. Prior treatment with CAR-T or adoptive cell therapy 2. Prior allogeneic transplant. 3. No bridging therapy permitted. 4. Active central nervous system disease from lymphoma. MRI of the brain with no evidence of CNS lymphoma if prior history of CNS involvement.
- 5. Prior history of allergic reactions to any of the reagents used in the rapcabtagene autoleucel infusion.
- 6. History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
- 7. History of T-cell histiocyte-rich large B-cell lymphoma. 8. Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment.
- 9. Women who are pregnant or breastfeeding 10. History of invasive malignancy unless the patient has been disease-free for two years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapcabtagene autoleucel (YTB323)Autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy manufactured from participant-derived T cells. Participants undergo leukapheresis for cell collection, receive lymphodepleting chemotherapy, followed by a single intravenous infusion of rapcabtagene autoleucel (YTB323). | Biological | Rapcabtagene Autoleucel (YTB323) Treatment Cohort |
Primary outcome
Minimal Residual Disease (MRD) Conversion Rate at Day 90
Time frame: Day 90 (3 months ± 2 weeks) post-infusion
Proportion of participants who achieve conversion from MRD-positive status at baseline to MRD-negative status at Day 90 (± 2 weeks) following infusion of rapcabtagene autoleucel (YTB323).
3 secondary outcomes
Progression free survival
Time frame: 12 months
Incidence of Adverse Events
Time frame: From infusion through Day 28 post-infusion
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: From infusion through Day 28 post-infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saurabh Dahiya, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rapcabtagene autoleucel (YTB323) in people with Large-cell Lymphoma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunny Salazar ((650) 725-7540, sunnysw@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Residual Disease (MRD) Conversion Rate at Day 90 (time frame: Day 90 (3 months ± 2 weeks) post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.