A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DeepTag-GPRC5D Targeted CAR T-cells.
- Who it may be relevant to
- Registry conditions: Relapse/Refractory Multiple Myeloma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Detailed description
In this study, 60 patients with relapsed refractory multiple myeloma were proposed to undergo DeepTag-GPRC5D CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of DeepTag-GPRC5D CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on DeepTag-GPRC5D CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.
Interventions
- Biological DeepTag-GPRC5D Targeted CAR T-cells
Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion
Primary outcome measures
- Dose-limiting toxicity (DLT) [Time frame: Up to 28 years after Treatment]
- Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after Treatment]
Secondary outcome measures (3)
- Multiple Myeloma (MM), Overall response rate (ORR) [Time frame: Up to 2 years after Treatment]
- Progression-free survival (PFS) [Time frame: Up to 2 years after Treatment]
- Duration of remission,DOR [Time frame: Up to 1 years after Treatment]
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:
- Lymphocyte count>0.3×10e9/L;
- Neutrophils ≥0.5×10e9/L;
- Hemoglobin ≥60g/L;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The first affiliated hospital of medical college of zhejiang university — Hangzhou
Identifiers
NCT: NCT06084962 · TXB2023018