Diffuse Large B Cell LymphomaPhase 3NCT05020392

Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma

A Phase 3 study testing BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 Cells and Fludarabine-based chemotherapy + CAR-T-CD19 Cells in people with Diffuse Large B Cell Lymphoma and Burkitt Lymphoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a single-center, open-label and pragmatic clinical trial to evaluate the primary efficacy and safety of anti-CD19 chimeric antigen receptor (CAR)-modified T cells (CART-CD19) with concurrent BTK inhibitor in patients with relapsed or refractory B cell lymphoma Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diffuse Large B Cell Lymphoma, Burkitt Lymphoma, Follicular Lymphoma
What is being tested?: BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 Cells and Fludarabine-based chemotherapy + CAR-T-CD19 Cells
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 14 Sep 2021to 13 Oct 2024
Phase: Phase 3
Are there results?: None posted in the registry

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged ≥ 18 years and ≤70 years.
Expected survival over 6 months.
Eastern Cooperative Oncology Group score≤ 2.
Diagnosed pathologically and histologically CD19+B cell lymphoma, including mantle cell lymphoma, chronic lymphocytic leukemia, follicular cell lymphoma, Burkitt lymphoma and diffuse large B cell lymphoma.
Patients have failed at least 1 line of prior therapy
Negativity of blood pregnancy test for woman, and participants use effective methods of contraception until last follow-up.
Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
-

Who cannot join

Investigators judge the patients with gastrointestinal lymph node and/or central nervous system involvement who may be at high-risk of receiving CAR-T-CD19 cell treatment.
Existing or preexisting CNS conditions, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS related autoimmune diseases.
Patients with graft-versus-host reaction and need immunosuppressive agents, or patients with autoimmune diseases.
Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within five years.
History of Richter's syndrome.
History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.

Show all 19Show fewer

Patients who are pregnant or breast-feeding.
Patients with any one of the following terms:
Creatine >2.5mg/dl (221.0umol/L). B. Alanine aminotransferase/aspartate aminotransferase >3 times the upper limit of normal (ULN).
Total bilirubin>2.0 mg/dl (34.2umol/L).
Major surgery within 4 weeks of randomization.
Systemic steroids are used within 2 weeks before apheresis (Except for those who are using inhaled steroids recently or currently).
Patients receive cytotoxic chemotherapy or radiotherapy within 21 days before enrollment (Tyrosine kinase inhibitors or other targeted therapies can be used two weeks before lymphodepleting chemotherapy).
Prior treatment with any gene therapy product.
Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection.
Systemic fungal, bacterial, viral, or other infection that is not controlled.
The absolute value of lymphocytes was too low to manufacture CAR-T cells.
Other conditions considered inappropriate by the researcher.
-

Trial locations and contacts

1 site in 1 country.

Heng Mei contact

Wenjing Luo contact

China1 site, 1 recruiting

Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heng Mei, M.D., Ph.D, 027-8572600, hmei@hust.edu.cn
Wenjing Luo, 15927552323, weerfi1211@hust.edu.cn
Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma：a Single-center, Open-label, Pragmatic Clinical Trial

Read the detailed description

Anti-CD19 chimeric antigen receptor (CAR) T-cell has shown dramatical efficacy in B cell malignancies. And Bruton tyrosine kinase (BTK) inhibitor agents have been validated as an effective drug to treat B cell malignancies. Combined therapies comprising ibrutinib (a BTK inhibitor) and anti-CD19 CAR-T cells in patients with CLL after ibrutinib failure are considered feasible and safe.

Ibrutinib is the first-generation BTK inhibitror and Zanubrutinib is the second-generation BTK inhibitor. Orelabrutinib is a newly developed BTK inhibitor with high selectivity and have received its approval in China. Autologous cells derived T cells are purified and transduced with a lentiviral vector encoding the humanized CD19 scFv.

To evaluate whether the addition of BTK inhibitor (Ibrutinib, Zanubrutinib and Orelabrutinib) in anti-CD19 CAR-T cells therapy would further improve efficacy and safety, we intend to conduct this pragmatic clinical trial.

Conditions: Diffuse Large B Cell Lymphoma, Burkitt Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
Being tested: BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 Cells, Fludarabine-based chemotherapy + CAR-T-CD19 Cells
Medical subject headings: Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma, Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 CellsDrug
BTK inhibitor from enrollment to more than 90 days after CAR-T-CD19 infusion. Fludarabine-based lymphodepletion chemotherapy was followed by CART19 infusion at a dose of 1x10^6/kg on day 0 and day 1 respectively.
Fludarabine-based chemotherapy + CAR-T-CD19 CellsDrug
Fludarabine-based lymphodepletion chemotherapy was followed by CART19 infusion at a dose of 1x10^6/kg on day 0 and day 1 respectively.

Study groups in NCT05020392
Study group	Role	What they receive
Effective of CAR-T-CD19 cells with concurrent BTK inhibitor	Experimental	After enrollment, all subjects will receive oral BTK inhibitor immediately and BTK inhibitor treatment will continue for up to 90 days (or longer for who are benefiting from BTK inhibitor) after CAR-T-CD19 infusion. Eligible patients will undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMCs) for CAR T-cell production. Upon successful generation CAR-T-CD19 product, participants will receive fludarabine-based lymphodepletion chemotherapy, followed by infusion of CAR-T-CD19 cells (2*10^6 cells/kg) on day 0 and day 1 respectively. Receives: Drug: BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 Cells
Effective of CAR-T-CD19 cells monotherapy	Active comparator	Eligible patients will undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMCs) for CAR T-cell production. Upon successful generation CAR-T-CD19 product, participants will receive fludarabine-based lymphodepletion chemotherapy, followed by infusion of CAR-T-CD19 cells (2*10^6 cells/kg) on day 0 and day 1 respectively. Receives: Drug: Fludarabine-based chemotherapy + CAR-T-CD19 Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-related Adverse Events
Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: within 2 years after infusion

Secondary outcomes (6)

Overall response rate (ORR) of administering CAR-T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory B cell lymphoma.
ORR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 2 years after infusion
Duration of Response (DOR) of administering CAR- T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory CD19+ B-cell lymphoma.
DOR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 2 years after infusion
Overall survival (OS) of administering CAR- T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory CD19+ B-cell lymphoma.
OS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 2 years after infusion
PFS will be assessed from CAR-T cell infusion to death or last follow-up
Progress-free survival (PFS) of administering CAR- T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory CD19+ B-cell lymphoma.
Measured: within 2 years after infusion
Complete response rate (CR) of administering CAR-T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory B cell lymphoma.
CR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Measured: within 2 years after infusion
Partial response rate (PR) of administering CAR-T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory B cell lymphoma.
PR will be assessed from CAR-T cell infusion to death or last follow-up.
Measured: within 2 years after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202113 Oct 2024

First posted25 Aug 2021
Study start14 Sep 2021
Primary completion13 Oct 2023 (estimated)
Study completion13 Oct 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This study was a pragmatic clinical trial in which patients were divided into two groups, one receiving anti-CD19 CAR-T cells infusion, the other group receiving anti-CD19 CAR-T cells infusion and concurrent oral BTK inhibitor.
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05020392
Sponsor's protocol ID: auto-CART-CD19 cells and BTKi
Status last verified: Jul 2023
First submitted: 19 Aug 2021
Last updated: 25 Jul 2023
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gauthier J, Hirayama AV, Purushe J, Hay KA, Lymp J, Li DH, Yeung CCS, Sheih A, Pender BS, Hawkins RM, Vakil A, Phi TD, Steinmetz RN, Shadman M, Riddell SR, Maloney DG, Turtle CJ. Feasibility and efficacy of CD19-targeted CAR T cells with concurrent ibrutinib for CLL after ibrutinib failure. Blood. 2020 May 7;135(19):1650-1660. doi: 10.1182/blood.2019002936.
PubMed 32076701
Fraietta JA, Beckwith KA, Patel PR, Ruella M, Zheng Z, Barrett DM, Lacey SF, Melenhorst JJ, McGettigan SE, Cook DR, Zhang C, Xu J, Do P, Hulitt J, Kudchodkar SB, Cogdill AP, Gill S, Porter DL, Woyach JA, Long M, Johnson AJ, Maddocks K, Muthusamy N, Levine BL, June CH, Byrd JC, Maus MV. Ibrutinib enhances chimeric antigen receptor T-cell engraftment and efficacy in leukemia. Blood. 2016 Mar 3;127(9):1117-27. doi: 10.1182/blood-2015-11-679134. Epub 2016 Jan 26.
PubMed 26813675
Cameron F, Sanford M. Ibrutinib: first global approval. Drugs. 2014 Feb;74(2):263-71. doi: 10.1007/s40265-014-0178-8.
PubMed 24464309
Luo W, Zhang Y, Li C, Xu J, Wu Z, Wang X, Kang Y, Liao D, Kou H, Xie W, Xiong W, Deng J, Mei H, Hu Y. BTK Inhibitor Synergizes With CD19-Targeted Chimeric Antigen Receptor-T Cells in Patients With Relapsed or Refractory B-Cell Lymphoma: An Open-Label Pragmatic Clinical Trial. Cancer Med. 2025 Oct;14(20):e71321. doi: 10.1002/cam4.71321.
PubMed 41123227

Want to know more?

Heng Mei

027-8572600

hmei@hust.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma：a Single-center, Open-label, Pragmatic Clinical Trial
ClinicalTrials.gov ID: NCT05020392
Acronym / sponsor ID: auto-CART-CD19 cells and BTKi
Conditions: Diffuse Large B Cell Lymphoma, Burkitt Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Collaborators: Wuhan Si'an Medical Technology Co., Ltd
Study start: 14 Sep 2021 (actual)
Primary completion: 13 Oct 2023 (estimated)
Study completion: 13 Oct 2024 (estimated)
First posted: 25 Aug 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This study was a pragmatic clinical trial in which patients were divided into two groups, one receiving anti-CD19 CAR-T cells infusion, the other group receiving anti-CD19 CAR-T cells infusion and concurrent oral BTK inhibitor.

Arm	Type	Receives
Effective of CAR-T-CD19 cells with concurrent BTK inhibitor	Experimental	Drug: BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 CellsAfter enrollment, all subjects will receive oral BTK inhibitor immediately and BTK inhibitor treatment will continue for up to 90 days (or longer for who are benefiting from BTK inhibitor) after CAR-T-CD19 infusion. Eligible patients will undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMCs) for CAR T-cell production. Upon successful generation CAR-T-CD19 product, participants will receive fludarabine-based lymphodepletion chemotherapy, followed by infusion of CAR-T-CD19 cells (2*10^6 cells/kg) on day 0 and day 1 respectively.
Effective of CAR-T-CD19 cells monotherapy	Active comparator	Drug: Fludarabine-based chemotherapy + CAR-T-CD19 CellsEligible patients will undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMCs) for CAR T-cell production. Upon successful generation CAR-T-CD19 product, participants will receive fludarabine-based lymphodepletion chemotherapy, followed by infusion of CAR-T-CD19 cells (2*10^6 cells/kg) on day 0 and day 1 respectively.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Aged ≥ 18 years and ≤70 years.
Expected survival over 6 months.
Eastern Cooperative Oncology Group score≤ 2.
Diagnosed pathologically and histologically CD19+B cell lymphoma, including mantle cell lymphoma, chronic lymphocytic leukemia, follicular cell lymphoma, Burkitt lymphoma and diffuse large B cell lymphoma.
Patients have failed at least 1 line of prior therapy

Key exclusion criteria (19 listed)

Investigators judge the patients with gastrointestinal lymph node and/or central nervous system involvement who may be at high-risk of receiving CAR-T-CD19 cell treatment.
Existing or preexisting CNS conditions, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS related autoimmune diseases.
Patients with graft-versus-host reaction and need immunosuppressive agents, or patients with autoimmune diseases.
Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within five years.
History of Richter's syndrome.

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
BTK inhibitor+ Fludarabine-based chemotherapy + CAR-T-CD19 CellsBTK inhibitor from enrollment to more than 90 days after CAR-T-CD19 infusion. Fludarabine-based lymphodepletion chemotherapy was followed by CART19 infusion at a dose of 1x10^6/kg on day 0 and day 1 respectively.	Drug	Effective of CAR-T-CD19 cells with concurrent BTK inhibitor
Fludarabine-based chemotherapy + CAR-T-CD19 CellsFludarabine-based lymphodepletion chemotherapy was followed by CART19 infusion at a dose of 1x10^6/kg on day 0 and day 1 respectively.	Drug	Effective of CAR-T-CD19 cells monotherapy

Primary outcome

Incidence of Treatment-related Adverse Events
Time frame: within 2 years after infusion
Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

6 secondary outcomes

Overall response rate (ORR) of administering CAR-T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory B cell lymphoma.
Time frame: within 2 years after infusion
Duration of Response (DOR) of administering CAR- T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory CD19+ B-cell lymphoma.
Time frame: within 2 years after infusion
Overall survival (OS) of administering CAR- T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory CD19+ B-cell lymphoma.
Time frame: within 2 years after infusion
PFS will be assessed from CAR-T cell infusion to death or last follow-up
Time frame: within 2 years after infusion
Complete response rate (CR) of administering CAR-T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory B cell lymphoma.
Time frame: within 2 years after infusion
Partial response rate (PR) of administering CAR-T-CD19 cells or CAR-T-CD19 cells with oral BTK inhibitor in Relapsed/Refractory B cell lymphoma.
Time frame: within 2 years after infusion

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
Background: PubMed 32076701Gauthier J, Hirayama AV, Purushe J, Hay KA, Lymp J, Li DH, Yeung CCS, Sheih A, Pender BS, Hawkins RM, Vakil A, Phi TD, Steinmetz RN, Shadman M, Riddell SR, Maloney DG, Turtle CJ. Feasibility and efficacy of CD19-targeted CAR T cells with concurrent ibrutinib for CLL after ibrutinib failure. Blood. 2020 May 7;135(19):1650-1660. doi: 10.1182/blood.2019002936.
Background: PubMed 26813675Fraietta JA, Beckwith KA, Patel PR, Ruella M, Zheng Z, Barrett DM, Lacey SF, Melenhorst JJ, McGettigan SE, Cook DR, Zhang C, Xu J, Do P, Hulitt J, Kudchodkar SB, Cogdill AP, Gill S, Porter DL, Woyach JA, Long M, Johnson AJ, Maddocks K, Muthusamy N, Levine BL, June CH, Byrd JC, Maus MV. Ibrutinib enhances chimeric antigen receptor T-cell engraftment and efficacy in leukemia. Blood. 2016 Mar 3;127(9):1117-27. doi: 10.1182/blood-2015-11-679134. Epub 2016 Jan 26.
Background: PubMed 24464309Cameron F, Sanford M. Ibrutinib: first global approval. Drugs. 2014 Feb;74(2):263-71. doi: 10.1007/s40265-014-0178-8.
Derived from this study: PubMed 41123227Luo W, Zhang Y, Li C, Xu J, Wu Z, Wang X, Kang Y, Liao D, Kou H, Xie W, Xiong W, Deng J, Mei H, Hu Y. BTK Inhibitor Synergizes With CD19-Targeted Chimeric Antigen Receptor-T Cells in Patients With Relapsed or Refractory B-Cell Lymphoma: An Open-Label Pragmatic Clinical Trial. Cancer Med. 2025 Oct;14(20):e71321. doi: 10.1002/cam4.71321.
Individual participant dataSharing planned: No

Related trials for Diffuse Large B Cell Lymphoma

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Study of Oral MRT-2359 in Selected Cancer Patients
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Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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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. This study is not recruiting at the moment.

Heng Mei contact

Wenjing Luo contact

Yu Hu principal investigator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Heng Mei (027-8572600, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-related Adverse Events (time frame: within 2 years after infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05020392, which also lists 4 linked publications.

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 25 Jul 2023.