DeepTag-GPRC5D CAR-T Cells for Relapsed Multiple Myeloma
A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Recruiting
Phase 1Interventional Study
Relapse/Refractory Multiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
He Huang · Other
Who this trial is looking for
This trial is looking for adults with relapsed or refractory multiple myeloma who want to try a new treatment called DeepTag-GPRC5D CAR-T cell therapy. Participants will need to meet specific health criteria and will be closely monitored throughout the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have multiple myeloma.
I have tried at least three treatments before.
I agree to participate and provide consent.
I expect to live at least 12 more weeks.
I have a good performance status (ECOG 0-2).
I am not pregnant and will use effective contraception if female.
My blood counts meet the study's requirements.
You may not be able to join if
I have a history of severe brain injuries or disorders.
I have a serious heart condition or irregular heartbeat.
I am pregnant or breastfeeding.
I have an active HIV infection.
I have active hepatitis B or C infections.
I have taken systemic steroids in the past 2 weeks.
I have uncontrolled cancers other than multiple myeloma.
I have had an autologous stem cell transplant in the past 8 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Trial Locations
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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 fai…
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.
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