NCT07490613 A Phase I Study of SHR-3836 in Patients With Multiple Myeloma
| NCT ID | NCT07490613 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 99 participants in total. It began in 2026-06-02 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years, male or female 2. Expected survival ≥ 3 months 3. ECOG performance status 0 or 1 4. Diagnosed with active multiple myeloma per IMWG criteria 5. Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy. 6. Disease progression or non-response to the most recent therapy 7. Measurable disease as defined by serum/urine M-protein or serum free light chain 8. Adequate bone marrow, hepatic, renal, and coagulation function 9. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception 10. Willing and able to provide written informed consent and comply with study procedures Exclusion Criteria: 1. Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome. 2. Central nervous system involvement by tumor. 3. History of ≥ Grade 3 CRS with prior T-cell redirecting therapy. 4. Requirement for dialysis or plasmapheresis within 14 days prior to study drug. 5. Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies). 6. Concurrent participation in another clinical study. 7. Prior anti-tumor therapy within specified washout periods. 8. Major surgery within 28 days prior to informed consent or planned during the study. 9. Live attenuated vaccine within 4 weeks prior to first dose or planned during the study. 10. Significant comorbidity that in the investigator's judgment would interfere with study participation or safety. 11. Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo). 12. Active infection. 13. Known hypersensitivity or contraindication to SHR-3836.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07490613 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07490613 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07490613 currently recruiting?
Yes, NCT07490613 is actively recruiting participants. Contact the research team at drwudepei@163.com for enrollment information.
Where is the NCT07490613 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07490613 clinical trial?
NCT07490613 is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. The trial plans to enroll 99 participants.