A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChunrui Li
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
ESO-T01
DrugESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: ESO-T01 treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities (DLTs)
Dose limiting toxicity will be assessed after injection
Time frame
Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.2
Cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) would be graded according to the ASTCT consensus.
Time frame
up to Day 28 post-infusion3
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.
Time frame
up to Day 28 post-infusion4
Treatment-associated adverse effects (AEs)
All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time frame
up to 2 years after treatment of ESO-T01Secondary outcomes
1
Overall response rate (ORR)
Clinical efficacy can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Time frame
Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01.2
Complete response (CR) rate
sCR/CR can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Time frame
Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of ESO-T01.3
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.
Time frame
Through study completion, an average of 2 year4
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.
Time frame
up to 2 years after treatment of ESO-T01.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chunrui Li
Lead sponsor
Tongji Hospital
Sponsor institution
Shenzhen Pregene Biopharma Co., Ltd.
Collaborator
Source ClinicalTrials.gov