Relapsed/ Refractory Multiple MyelomaEarly Phase 1NCT06791681
A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma
A Early Phase 1 study testing ESO-T01 in people with Relapsed/ Refractory Multiple Myeloma, run by Chunrui Li at 1 site in China.
Trial summary
This is a single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/ Refractory Multiple Myeloma
- What is being tested?
- ESO-T01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2025to 30 Nov 2027
- Phase
- Early 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
- Age ≥ 18 years；
- Diagnosis of multiple myeloma (MM) confirmed according to the IMWG diagnostic criteria, with BCMA expression on MM cells determined by flow cytometry or immunohistochemistry;
- Previously treated with at least 2 lines of anti-MM therapy, with at least 1 complete treatment cycle for each line, and disease progression within 12 months after the most recent anti-myeloma treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, along with disease progression within 2 months after the most recent anti-myeloma treatment (according to the IMWG diagnostic criteria);
- Disease must be measurable at screening, meeting at least one of the following criteria:Serum M-protein level ≥ 0.5 g/dL; Urinary M-protein level ≥ 200 mg/24h; Serum involved free light chain ≥ 10 mg/dL and an abnormal serum free light chain κ/λ ratio;
- ECOG score 0-2, with an expected survival time ≥ 3 months;
- Bone marrow function at screening (or within 2 months prior to screening) meets the following criteria: a.Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin is allowed; for patients who meet the ≥6 g/dL criterion at screening, red blood cell transfusion is allowed to maintain hemoglobin ≥ 6 g/dL; b.Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor (G-CSF) within 1 week or pegylated G-CSF within 2 weeks prior to screening); c. Platelet count ≥ 50,000/μL; d. Lymphocyte count ≥ 500/μL; e. Absolute CD3-positive T cell count ≥ 150/μL;
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- Renal function at screening (or within 2 months prior to screening) should be normal, with a creatinine clearance ≥ 45 mL/min;
- Liver function at screening (or within 2 months prior to screening) must meet the following criteria: a. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × the upper limit of normal (ULN); b. Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert's syndrome, where direct bilirubin can be ≤ 1.5 × ULN); c. Albumin ≥ 3 g/dL;
- Cardiac function at screening (or within 2 months prior to screening) must meet the following criteria: a. Left ventricular ejection fraction ≥ 40% (measured by echocardiogram or MUGA scan); b. No clinically significant pericardial effusion detected; c. No clinically significant ECG abnormalities detected;
- Pulmonary function at screening (or within 2 months prior to screening) must meet the following criteria: Oxygen saturation ≥ 90%;No clinically significant pleural effusion detected;
- For women of childbearing potential, a negative pregnancy test must be obtained at screening and prior to drug infusion, and they must not be breastfeeding;
- Male and female subjects of childbearing potential must agree to use effective contraception from the time of informed consent until 1 year after the study drug administration;
- Male and female subjects of childbearing potential must agree not to donate sperm or eggs (oocytes) or other reproductive cells from the time of informed consent until 1 year after the study drug administration;
- The participant or their legally authorized representative must provide written informed consent (ICF), indicating their understanding of the purpose and procedures of the study and their willingness to participate.
Who cannot join
- Previous anticancer treatment (as determined by the investigator): a. Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive investigational medical devices within 5 half-lives; b. Received immune/non-immune-directed systemic therapy within 1 week; Received cytotoxic therapy within 1 week; c. Received proteasome inhibitors or immunomodulatory agent therapy within 2 weeks; d. Received radiotherapy within 4 weeks (if the radiation field covered ≤5% of bone marrow reserve, the subject is eligible regardless of the date of radiotherapy completion);
- Received allogeneic HSCT within 6 months prior to infusion, or autologous HSCT within 3 months prior to infusion;
- Other malignancies prior to screening (except the following): Malignancies treated with curative intent and no evidence of active disease ≥2 years before enrollment; Adequately treated non-melanoma skin cancer with no evidence of disease;
- Previously treated with any viral therapy using VSVG pseudotype virus;
- Serious uncontrolled infections during screening: Bacterial, viral, fungal, etc. infections;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with elevated peripheral blood HBV DNA levels within 6 months prior to infusion; Positive for hepatitis C antibody (HCV Ab) with elevated peripheral blood HCV RNA levels; Positive for HIV antibody; Positive for syphilis;
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- Symptomatic heart failure or significant arrhythmias: NYHA Class III or IV congestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months prior to signing ICF; Clinically significant ventricular arrhythmias or unexplained syncope (except when caused by vasovagal or dehydration); Significant non-ischemic cardiomyopathy history;
- Other significant diseases: Primary immunodeficiency; Stroke or seizure within 6 months prior to screening; Obvious clinical evidence of dementia or altered mental status; History of Parkinson's disease or Parkinsonism;
- Surgery within 2 weeks prior to treatment or planned surgery within 2 weeks post-treatment, except for local anesthesia procedures;
- Use of live-attenuated vaccines within 1 month before treatment;
- Known severe allergic reaction to ESO-T01 or its formulation components;
- Known severe allergic reaction to Tocilizumab;
- Inability to establish venous access;
- Any other condition deemed by the investigator as unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College
Wuhan, Hubei, 430000
Chunrui Li, 86-13647233185, cunrui5650@126.com
About this study
Official title: Clinical Study for Evaluating ESO-T01 Injection's Safety and Efficacy in Treating Relapsed/refractory Multiple Myeloma
This is a single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed/refractory multiple myeloma.
Read the detailed description
ESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR. Before infusion, the patients will be given the prophylaxis of acetaminophen and diphenhydramine. The designed dose-escalation includes four dose groups of dose A, B, C, and D. After infusion, patients will be followed for 2 years.
- Conditions
- Relapsed/ Refractory Multiple Myeloma
- Being tested
- ESO-T01
- Keywords
- ESO-T01, Multiple Myeloma, in vivo
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESO-T01Drug
Also called BCMA CAR-T
ESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR.
| Study group | Role | What they receive |
|---|---|---|
| ESO-T01 treatment group | Experimental | the third-generation self-inactivating lentiviral vector Receives: Drug: ESO-T01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Dose limiting toxicity will be assessed after injection
Measured: Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.
Cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) would be graded according to the ASTCT consensus.
Measured: up to Day 28 post-infusion
immune cell-associated immune effector cell-associated neurotoxicity syndrome (ICANS)
ICANS would be scored according to Immune Effector Cell-Associated Encephalopathy (ICE), and then graded by the ASTCT consensus.
Measured: up to Day 28 post-infusion
Treatment-associated adverse effects (AEs)
All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: up to 2 years after treatment of ESO-T01
Secondary outcomes (8)
Overall response rate (ORR)
Clinical efficacy can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Measured: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01.
Complete response (CR) rate
sCR/CR can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Measured: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01.
Duration of response (DOR)
DOR is defined as the interval between the first sCR, CR, VGPR, or PR after infusion and the disease progression or death.
Measured: Through study completion, an average of 2 year
Progression-free survival (PFS)
PFS is defined as the interval between a subject's receipt of ESO-T01 infusion and the first assessment of disease progression or death.
Measured: up to 2 years after treatment of ESO-T01.
Overall survival (OS)
OS is defined as the interval between a subject's receipt of ESO-T01 infusion and death from any cause.
Measured: up to 2 years after treatment of ESO-T01
Cmax
CAR-T kinetics would be detected by flow cytometry and droplet digital PCR in peripheral blood and bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells.
Measured: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01
Tmax
CAR-T kinetics would be detected by flow cytometry and droplet digital PCR in peripheral blood and bone marrow at each important time points. Tmax is the time of the occurrence of expansion peak.
Measured: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01
AUC(0-day 28)
CAR-T kinetics would be detected by flow cytometry and droplet digital PCR in peripheral blood and bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells. AUC(0- day28) refers to the area under curve of CAR-T cell expansion between infusion and day 28 post infusion. They all reflect the pharmacokinetics.
Measured: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28 after the treatment of ESO-T01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start27 Jan 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/ Refractory Multiple MyelomaStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunrui Li
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Responsible party
- Sponsor-investigator, Chunrui Li, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791681
- Sponsor's protocol ID
- PRG2402E
- Status last verified
- Nov 2024
- First submitted
- 9 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
An N, Wang D, Zhang P, Zhang J, Parone P, Hu J, Bao Y, Xu L, Ruan H, Wan Y, Wen X, Gao Y, Li C. In vivo generation of anti-BCMA CAR-T cells in relapsed or refractory multiple myeloma: a phase 1 study. Nat Med. 2026 Apr;32(4):1257-1266. doi: 10.1038/s41591-026-04244-6. Epub 2026 Mar 25.
PubMed 41882404
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Evaluating ESO-T01 Injection's Safety and Efficacy in Treating Relapsed/refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06791681
- Acronym / sponsor ID
- PRG2402E
- Conditions
- Relapsed/ Refractory Multiple Myeloma
- Keywords
- ESO-T01, Multiple Myeloma, in vivo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chunrui LiUniversity, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 24 Jan 2025 (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 single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed/refractory multiple myeloma.
Detailed description
ESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR. Before infusion, the patients will be given the prophylaxis of acetaminophen and diphenhydramine. The designed dose-escalation includes four dose groups of dose A, B, C, and D. After infusion, patients will be followed for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESO-T01 treatment group | Experimental | Drug: ESO-T01the third-generation self-inactivating lentiviral vector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years；
- Diagnosis of multiple myeloma (MM) confirmed according to the IMWG diagnostic criteria, with BCMA expression on MM cells determined by flow cytometry or immunohistochemistry;
- Previously treated with at least 2 lines of anti-MM therapy, with at least 1 complete treatment cycle for each line, and disease progression within 12 months after the most recent anti-myeloma treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, along with disease progression within 2 months after the most recent anti-myeloma treatment (according to the IMWG diagnostic criteria);
- Disease must be measurable at screening, meeting at least one of the following criteria:Serum M-protein level ≥ 0.5 g/dL; Urinary M-protein level ≥ 200 mg/24h; Serum involved free light chain ≥ 10 mg/dL and an abnormal serum free light chain κ/λ ratio;
- ECOG score 0-2, with an expected survival time ≥ 3 months;
Key exclusion criteria (14 listed)
- Previous anticancer treatment (as determined by the investigator): a. Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive investigational medical devices within 5 half-lives; b. Received immune/non-immune-directed systemic therapy within 1 week; Received cytotoxic therapy within 1 week; c. Received proteasome inhibitors or immunomodulatory agent therapy within 2 weeks; d. Received radiotherapy within 4 weeks (if the radiation field covered ≤5% of bone marrow reserve, the subject is eligible regardless of the date of radiotherapy completion);
- Received allogeneic HSCT within 6 months prior to infusion, or autologous HSCT within 3 months prior to infusion;
- Other malignancies prior to screening (except the following): Malignancies treated with curative intent and no evidence of active disease ≥2 years before enrollment; Adequately treated non-melanoma skin cancer with no evidence of disease;
- Previously treated with any viral therapy using VSVG pseudotype virus;
- Serious uncontrolled infections during screening: Bacterial, viral, fungal, etc. infections;
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 |
|---|---|---|
| ESO-T01Also: BCMA CAR-TESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR. | Drug | ESO-T01 treatment group |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.
Dose limiting toxicity will be assessed after injection
Cytokine release syndrome (CRS)
Time frame: up to Day 28 post-infusion
Cytokine release syndrome (CRS) would be graded according to the ASTCT consensus.
immune cell-associated immune effector cell-associated neurotoxicity syndrome (ICANS)
Time frame: up to Day 28 post-infusion
ICANS would be scored according to Immune Effector Cell-Associated Encephalopathy (ICE), and then graded by the ASTCT consensus.
Treatment-associated adverse effects (AEs)
Time frame: up to 2 years after treatment of ESO-T01
All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
8 secondary outcomes
Overall response rate (ORR)
Time frame: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01.
Complete response (CR) rate
Time frame: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01.
Duration of response (DOR)
Time frame: Through study completion, an average of 2 year
Progression-free survival (PFS)
Time frame: up to 2 years after treatment of ESO-T01.
Overall survival (OS)
Time frame: up to 2 years after treatment of ESO-T01
Cmax
Time frame: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01
Tmax
Time frame: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01
AUC(0-day 28)
Time frame: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28 after the treatment of ESO-T01
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 11 Feb 2025.
- Derived from this study: PubMed 41882404An N, Wang D, Zhang P, Zhang J, Parone P, Hu J, Bao Y, Xu L, Ruan H, Wan Y, Wen X, Gao Y, Li C. In vivo generation of anti-BCMA CAR-T cells in relapsed or refractory multiple myeloma: a phase 1 study. Nat Med. 2026 Apr;32(4):1257-1266. doi: 10.1038/s41591-026-04244-6. Epub 2026 Mar 25.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
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 ESO-T01 in people with Relapsed/ Refractory Multiple Myeloma, run by Chunrui Li 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 14 inclusion and 14 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 11 Feb 2025. 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?
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 Chunrui Li (86-13647233185, cunrui5650@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLTs) (time frame: Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.). The study lists 4 primary outcomes in all. 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 NCT06791681, which also lists 1 linked publication.
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 11 Feb 2025.