B Cell LymphomaEarly Phase 1NCT06662227
Universal CAR-T Cells (REVO-UWD-19) for Refractory and Relapsed B-Cell Tumors
A Early Phase 1 study testing Single dose injection of certain dose of UWD-19 and MMF Immunosuppression in people with B Cell Lymphoma and B Cell Leukemia, run by Wondercel Biotech (ShenZhen) at 1 site in China.
Trial summary
This study is a single-arm, single-center, investigator-initiated clinical trial. The primary objective is to evaluate the safety and preliminary efficacy of administering universal CD19 CAR-T cells to subjects with refractory and relapsed B-cell tumors. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- B Cell Lymphoma, B Cell Leukemia, B Cell Malignancy
- What is being tested?
- Single dose injection of certain dose of UWD-19 and MMF Immunosuppression
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 30 Dec 2029
- Phase
- Early Phase 1
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (or their guardians) understand the study and voluntarily sign the informed consent form, with an expected ability to complete follow-up evaluations and treatments as per study protocol.
- Age range: 3-70 years, no gender restrictions. Diagnosis of B-cell lymphoma, meeting the 2018 NCCN B-Cell Lymphoma guidelines (Version 5), with CD19 positivity confirmed by flow cytometry or immunohistochemistry.
- At least one evaluable or measurable lesion per Lugano 2014 criteria. Evaluable lesions are indicated by FDG uptake above liver levels on FDG/PET or by lymphoma-like characteristics on PET/CT. Measurable lesions require a nodal diameter >15 mm or extranodal lesion >10 mm (with post-radiation evidence of progression if previously irradiated). Cases without measurable lesions but with diffuse liver FDG uptake are excluded.
- Refractory and relapsed B-cell lymphoma, meeting at least one of the following: a. Received ≥2 cycles of standardized second-line or higher treatment, and meets Lugano 2014 criteria for best clinical response:
- Progressive Disease (PD) on the most recent treatment.
- Stable Disease (SD) lasting <6 months before progressing. b. Recurrence or progression ≤12 months post-autologous stem cell transplant. c. Based on investigator judgment, the potential benefit may outweigh risk in cases such as:
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- Recent SD with measurable disease progression but not meeting PD criteria. Partial remission (PR) or better lasting <6 months post-treatment, then progression.
- Intolerance to most recent chemotherapy. Relapsed/refractory CD19-positive acute B lymphoblastic leukemia.
- Laboratory values indicating adequate organ and marrow function, with no severe cardiac, pulmonary, hepatic, renal, or immune dysfunction:
- Serum albumin ≥25 g/L Creatinine clearance ≥30 mL/min/1.73 m² ALT and AST ≤3.0× ULN Total bilirubin ≤2.0× ULN (exceptions for congenital hyperbilirubinemia like Gilbert syndrome with direct bilirubin ≤1.5× ULN) PT and APTT <2× ULN Oxygen saturation ≥95% Blood transfusions allowed to maintain hemoglobin ≥8.0 g/dL. ECOG performance status 0-1. Expected survival time >90 days. Negative β-hCG test for women of childbearing potential at screening and prior to chemotherapy.
- Women of childbearing potential must use a highly effective contraceptive method (annual failure rate <1%) from the time of consent until 1 year after UWD-CD19 infusion, including:
- Non-user-dependent: implantable progestogen, IUD, hormone-releasing system, or partner vasectomy.
- User-dependent: combination hormonal contraception, progestogen-only pill, or injection.
Who cannot join
- History of aggressive malignancies other than B-cell lymphoma, except:
- Cancer in remission >2 years post-curative therapy. Non-melanoma skin cancer successfully treated and inactive.
- Prior anti-cancer therapy including:
- Targeted, epigenetic, or experimental drug therapy within 14 days or 5 half-lives.
- Cytotoxic therapy within 14 days. Immunomodulators within 7 days. Monoclonal antibodies within 21 days. Radiotherapy within 14 days. Active CNS involvement. Conditions like Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
- Active hepatitis B (HBsAg or HBcAb positive with viral load >1000 copies/ml), hepatitis C (HCV RNA positive), HIV, CMV, or syphilis positivity.
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- Severe allergy history, or known allergy to trial components, adjuvants, or animal-derived proteins.
- Severe cardiac conditions such as arrhythmias, unstable angina, recent MI, heart failure (NYHA III/IV), uncontrolled hypertension.
- Unstable systemic disease, including significant liver, kidney, or metabolic disease requiring medication.
- Acute/chronic GVHD or requiring immunosuppressants within 6 months. Active autoimmune or inflammatory neurologic diseases. Urgent tumor-related conditions requiring emergency treatment. Uncontrolled bacterial, fungal, or viral infections. Major surgery within 4 weeks or planned major surgery during the study. Live virus vaccination within 4 weeks prior to screening. Severe psychiatric disorders. History of substance abuse. Pregnant or lactating women, or individuals planning conception within 2 years of cell infusion.
- Any contraindications per investigator's judgment due to clinical standards or patient's condition.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: A Clinical Study Evaluating the Safety and Efficacy of Universal CD19-Targeted CAR-T (UWD-CD19) Therapy for Refractory and Relapsed B-Cell Tumors
This study is a single-arm, single-center, investigator-initiated clinical trial. The primary objective is to evaluate the safety and preliminary efficacy of administering universal CD19 CAR-T cells to subjects with refractory and relapsed B-cell tumors. Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of universal UWD-19 to assess its safety and efficacy. Subjects will be hospitalized for a period, and after discharge, they will undergo periodic efficacy assessments and long-term survival follow-up for at least five years.
Read the detailed description
This study is a single-arm clinical trial evaluating the universal CD19-targeted CAR-T cell therapy (UWD-CD19) in treating relapsed and refractory B-cell tumors. Initiated by investigators, the study aims to assess the safety and preliminary efficacy of this cell therapy, providing new therapeutic options for patients with B-cell tumors-a class of hematologic malignancies that often recur and resist standard treatments, posing substantial treatment challenges.
CD19 is a specific marker predominantly expressed on the surface of B-cells, making it a prime target for CAR-T cell therapies. CAR-T therapy involves extracting T cells from a healthy donor and genetically engineering them to recognize and attack CD19-expressing tumor cells. UWD-CD19, a "universal" CAR-T cell product, seeks to enhance therapy adaptability, allowing it to effectively target B-cell tumors across different patient groups.
Study Objectives The primary objective of this study is to observe the therapeutic response in patients with relapsed or refractory B-cell tumors through a single infusion of UWD-CD19, specifically focusing on safety, tolerability, and preliminary efficacy. The research team will also conduct long-term follow-up on patients to assess the durability of treatment effects and survival rates, providing data support for the potential wider application of this novel therapy.
Inclusion Criteria: Patients aged between 3 and 70, with no gender restrictions, must meet diagnostic criteria for B-cell lymphoma with CD19-positive tumor cells. Patients should have an evaluable or measurable lesion as defined by the 2014 Lugano criteria.
Preconditioning: Eligible patients will receive lymphodepleting chemotherapy with Fludarabine and Cyclophosphamide before cell infusion to suppress the immune system and optimize CAR-T cell performance.
CAR-T Cell Infusion: Patients will receive a one-time infusion of UWD-CD19 cells, and their responses will be closely monitored during and after infusion to ensure safety.
Follow-up and Efficacy Assessment: Following treatment, patients will be hospitalized for a period and, after discharge, return regularly for follow-up and efficacy evaluations. The research team will conduct survival monitoring for at least five years.
Inclusion and Exclusion Criteria To ensure the study's safety and scientific rigor, strict inclusion and exclusion criteria are set. Patients must meet requirements across age, pathology, disease stage, and organ function, and should not have other severe health conditions (e.g., active CNS involvement, severe cardiovascular disease, serious infections) that could confound efficacy assessments or increase patient risk.
Potential Impact If results demonstrate good safety and efficacy of UWD-CD19 cell therapy in patients with relapsed and refractory B-cell tumors, this could open a new treatment pathway for this patient population. Universal CAR-T cell therapy could eventually extend to more hematologic malignancies, offering hope and support to patients facing significant treatment barriers.
Ethics and Risk Management The study has been approved by the Medical Ethics Committee, and the research team will strictly adhere to ethical standards, ensuring patients provide informed consent and receive adequate medical support. Since CAR-T therapy may present potential side effects (e.g., cytokine release syndrome, neurotoxicity), patients will be under real-time monitoring, with prompt intervention provided as needed.
This study aims to provide new insights and therapeutic approaches for B-cell tumor treatment through an in-depth evaluation of UWD-CD19 cell therapy. The research team will continue observing and recording patients' responses, establishing a scientific foundation for future immunotherapies in oncology and offering patients the prospect of long-term health benefits and quality of life improvements.
- Conditions
- B Cell Lymphoma, B Cell Leukemia, B Cell Malignancy
- Being tested
- Single dose injection of certain dose of UWD-19, MMF Immunosuppression
- Keywords
- CAR-T, Universal CAR-T, CD19, B cell lymphoma, B cell leukemia
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose injection of certain dose of UWD-19Biological
Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of certain dose of universal UWD-19 cells
MMF ImmunosuppressionDrug
One day after the completion of fludarabine preconditioning (D-2), initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID) for 15 consecutive days, or extend the duration appropriately based on CAR-T cell expansion status (discontinuation may occur at the end of CAR-T cell expansion or on the day of patient discharge). The maximum duration of administration must not exceed 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Off-the-shelf REVO-UWD-19 | Experimental | Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning, followed by a one-time injection of universal UWD-19 cells Receives: Biological: Single dose injection of certain dose of UWD-19; Drug: MMF Immunosuppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The highest dose of UWD-19 CAR-T cells that can be administered without causing unacceptable side effects, measured during the dose escalation phase.
Measured: [Time Frame: Within the first month post-infusion.]
Dose-Limiting Toxicities (DLT)
The incidence of treatment-related toxicities that prevent further dose escalation.
Measured: [Time Frame: Within the first month post-infusion.]
Treatment-Emergent Adverse Events (TEAE)
The frequency and severity of adverse events that arise following the administration of UWD-19-CAR-T cells.
Measured: [Time Frame: From the administration of UWD-19 CAR-T cells through six months post-infusion]
Secondary outcomes (4)
Objective Response Rate (ORR)
The proportion of patients with a measurable reduction in tumor size (complete or partial response) following UWD-19 CAR-T therapy.
Measured: [Time Frame: Measured at 3 and 6 months after treatment.]
Progression-Free Survival (PFS)
The length of time during and after treatment that the patient lives without disease progression.
Measured: [Time Frame: From the start of treatment up to 5 years.]
Overall Survival (OS)
The duration from the start of treatment to the time of death from any cause.
Measured: [Time Frame: From the start of treatment up to maximum follow-up period of five years.]
Duration of Response (DOR)
The time from initial tumor response (CR or PR) to disease progression or relapse or any cause of death.
Measured: [Time Frame: From the administration of UWD-19 CAR-T cells to a maximum follow-up period of five years.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start24 Oct 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Why it stopped: Because the implementation of the new regulation policy by the Chinese authority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wondercel Biotech (ShenZhen)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pengcheng He, M.D. Ph.D., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662227
- Sponsor's protocol ID
- 2024-REVO-UWD-19
- Status last verified
- May 2026
- First submitted
- 25 Oct 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Efficacy of Universal CD19-Targeted CAR-T (UWD-CD19) Therapy for Refractory and Relapsed B-Cell Tumors
- ClinicalTrials.gov ID
- NCT06662227
- Acronym / sponsor ID
- 2024-REVO-UWD-19
- Conditions
- B Cell Lymphoma, B Cell Leukemia, B Cell Malignancy
- Keywords
- CAR-T, Universal CAR-T, CD19, B cell lymphoma, B cell leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because the implementation of the new regulation policy by the Chinese authority
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wondercel Biotech (ShenZhen)Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 28 Oct 2024 (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 study is a single-arm, single-center, investigator-initiated clinical trial. The primary objective is to evaluate the safety and preliminary efficacy of administering universal CD19 CAR-T cells to subjects with refractory and relapsed B-cell tumors. Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of universal UWD-19 to assess its safety and efficacy. Subjects will be hospitalized for a period, and after discharge, they will undergo periodic efficacy assessments and long-term survival follow-up for at least five years.
Detailed description
This study is a single-arm clinical trial evaluating the universal CD19-targeted CAR-T cell therapy (UWD-CD19) in treating relapsed and refractory B-cell tumors. Initiated by investigators, the study aims to assess the safety and preliminary efficacy of this cell therapy, providing new therapeutic options for patients with B-cell tumors-a class of hematologic malignancies that often recur and resist standard treatments, posing substantial treatment challenges.
CD19 is a specific marker predominantly expressed on the surface of B-cells, making it a prime target for CAR-T cell therapies. CAR-T therapy involves extracting T cells from a healthy donor and genetically engineering them to recognize and attack CD19-expressing tumor cells. UWD-CD19, a "universal" CAR-T cell product, seeks to enhance therapy adaptability, allowing it to effectively target B-cell tumors across different patient groups.
Study Objectives The primary objective of this study is to observe the therapeutic response in patients with relapsed or refractory B-cell tumors through a single infusion of UWD-CD19, specifically focusing on safety, tolerability, and preliminary efficacy. The research team will also conduct long-term follow-up on patients to assess the durability of treatment effects and survival rates, providing data support for the potential wider application of this novel therapy.
Inclusion Criteria: Patients aged between 3 and 70, with no gender restrictions, must meet diagnostic criteria for B-cell lymphoma with CD19-positive tumor cells. Patients should have an evaluable or measurable lesion as defined by the 2014 Lugano criteria.
Preconditioning: Eligible patients will receive lymphodepleting chemotherapy with Fludarabine and Cyclophosphamide before cell infusion to suppress the immune system and optimize CAR-T cell performance.
CAR-T Cell Infusion: Patients will receive a one-time infusion of UWD-CD19 cells, and their responses will be closely monitored during and after infusion to ensure safety.
Follow-up and Efficacy Assessment: Following treatment, patients will be hospitalized for a period and, after discharge, return regularly for follow-up and efficacy evaluations. The research team will conduct survival monitoring for at least five years.
Inclusion and Exclusion Criteria To ensure the study's safety and scientific rigor, strict inclusion and exclusion criteria are set. Patients must meet requirements across age, pathology, disease stage, and organ function, and should not have other severe health conditions (e.g., active CNS involvement, severe cardiovascular disease, serious infections) that could confound efficacy assessments or increase patient risk.
Potential Impact If results demonstrate good safety and efficacy of UWD-CD19 cell therapy in patients with relapsed and refractory B-cell tumors, this could open a new treatment pathway for this patient population. Universal CAR-T cell therapy could eventually extend to more hematologic malignancies, offering hope and support to patients facing significant treatment barriers.
Ethics and Risk Management The study has been approved by the Medical Ethics Committee, and the research team will strictly adhere to ethical standards, ensuring patients provide informed consent and receive adequate medical support. Since CAR-T therapy may present potential side effects (e.g., cytokine release syndrome, neurotoxicity), patients will be under real-time monitoring, with prompt intervention provided as needed.
This study aims to provide new insights and therapeutic approaches for B-cell tumor treatment through an in-depth evaluation of UWD-CD19 cell therapy. The research team will continue observing and recording patients' responses, establishing a scientific foundation for future immunotherapies in oncology and offering patients the prospect of long-term health benefits and quality of life improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Off-the-shelf REVO-UWD-19 | Experimental | Biological: Single dose injection of certain dose of UWD-19, Drug: MMF ImmunosuppressionEligible participants will undergo FC lymphodepleting chemotherapy preconditioning, followed by a one-time injection of universal UWD-19 cells |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Patients (or their guardians) understand the study and voluntarily sign the informed consent form, with an expected ability to complete follow-up evaluations and treatments as per study protocol.
- Age range: 3-70 years, no gender restrictions. Diagnosis of B-cell lymphoma, meeting the 2018 NCCN B-Cell Lymphoma guidelines (Version 5), with CD19 positivity confirmed by flow cytometry or immunohistochemistry.
- At least one evaluable or measurable lesion per Lugano 2014 criteria. Evaluable lesions are indicated by FDG uptake above liver levels on FDG/PET or by lymphoma-like characteristics on PET/CT. Measurable lesions require a nodal diameter >15 mm or extranodal lesion >10 mm (with post-radiation evidence of progression if previously irradiated). Cases without measurable lesions but with diffuse liver FDG uptake are excluded.
- Refractory and relapsed B-cell lymphoma, meeting at least one of the following: a. Received ≥2 cycles of standardized second-line or higher treatment, and meets Lugano 2014 criteria for best clinical response:
- Progressive Disease (PD) on the most recent treatment.
Key exclusion criteria (11 listed)
- History of aggressive malignancies other than B-cell lymphoma, except:
- Cancer in remission >2 years post-curative therapy. Non-melanoma skin cancer successfully treated and inactive.
- Targeted, epigenetic, or experimental drug therapy within 14 days or 5 half-lives.
- Cytotoxic therapy within 14 days. Immunomodulators within 7 days. Monoclonal antibodies within 21 days. Radiotherapy within 14 days. Active CNS involvement. Conditions like Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
- Active hepatitis B (HBsAg or HBcAb positive with viral load >1000 copies/ml), hepatitis C (HCV RNA positive), HIV, CMV, or syphilis positivity.
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 |
|---|---|---|
| Single dose injection of certain dose of UWD-19Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of certain dose of universal UWD-19 cells | Biological | Off-the-shelf REVO-UWD-19 |
| MMF ImmunosuppressionOne day after the completion of fludarabine preconditioning (D-2), initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID) for 15 consecutive days, or extend the duration appropriately based on CAR-T cell expansion status (discontinuation may occur at the end of CAR-T cell expansion or on the day of patient discharge). The maximum duration of administration must not exceed 30 days. | Drug | Off-the-shelf REVO-UWD-19 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: [Time Frame: Within the first month post-infusion.]
The highest dose of UWD-19 CAR-T cells that can be administered without causing unacceptable side effects, measured during the dose escalation phase.
Dose-Limiting Toxicities (DLT)
Time frame: [Time Frame: Within the first month post-infusion.]
The incidence of treatment-related toxicities that prevent further dose escalation.
Treatment-Emergent Adverse Events (TEAE)
Time frame: [Time Frame: From the administration of UWD-19 CAR-T cells through six months post-infusion]
The frequency and severity of adverse events that arise following the administration of UWD-19-CAR-T cells.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: [Time Frame: Measured at 3 and 6 months after treatment.]
Progression-Free Survival (PFS)
Time frame: [Time Frame: From the start of treatment up to 5 years.]
Overall Survival (OS)
Time frame: [Time Frame: From the start of treatment up to maximum follow-up period of five years.]
Duration of Response (DOR)
Time frame: [Time Frame: From the administration of UWD-19 CAR-T cells to a maximum follow-up period of five years.]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Pengcheng He, M.D. Ph.D. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Single dose injection of certain dose of UWD-19 and MMF Immunosuppression in people with B Cell Lymphoma and B Cell Leukemia, run by Wondercel Biotech (ShenZhen) at 1 site in China.
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 13 inclusion and 11 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: paused, as of the sponsor's last update on 7 May 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: [Time Frame: Within the first month post-infusion.]). The study lists 3 primary outcomes in all. 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 7 May 2026.