NCT06084962 A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
| NCT ID | NCT06084962 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | He Huang |
| Condition | Relapse/Refractory Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2026-10-20 |
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 40 participants in total. It began in 2023-10-20 with a primary completion date of 2026-10-20.
⚠ 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
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Eligibility Criteria
Inclusion Criteria: * 1\. Those who voluntarily participated in this trial and provided informed consent; * 2\. Gender unlimited，18\<Age≤75; * 3\. Estimated life expectancy of minimum of 12 weeks; * 4\. ECOG 0-2; * 5\. Diagnosed as multiple myeloma according to the IMWG criteria; * 6\. Subjects failed treatment with at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors (PIs) ，immunomodulatory agents (IMiDs) and CD38 antibody）, or recived the above three treatment methods experienced disease progression or recurrence during the most recent treatment process or within 6 months after the end of treatment, Difficulty in treatment includes primary difficulty in treatment ( patient has not achieved minimal remission or disease progression during treatment) or secondary difficulty in treatment (patient develops disease progression within 60 days after completion of treatment); * 7\. Women have a negative urine pregnancy test before the start of medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up; * 8\. The blood routine meets the following standards: 1. Lymphocyte count\>0.3×10e9/L; 2. Neutrophils ≥0.5×10e9/L; 3. Hemoglobin ≥60g/L; 4. Platelet ≥30×10e9/L Exclusion Criteria: * 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; * 3\. Pregnant (or lactating) women; * 4\. Patients with HIV infection; * 5\. Active infection of hepatitis B virus or hepatitis C virus; * 6\. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; * 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 8\. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; * 9\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study; * 10\. Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening; * 11\. Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment; * 12\. Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period; * 13\. Patients received allogeneic stem cell therapy; * 14\. Any unsuitable to participate in this trial judged by the investigator.
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT06084962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Relapse/Refractory 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 NCT06084962 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 NCT06084962 currently recruiting?
Yes, NCT06084962 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT06084962 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06084962 clinical trial?
NCT06084962 is sponsored by He Huang. The principal investigator is He Huang, MD at Zhejiang University. The trial plans to enroll 40 participants.