Relapse/Refractory Multiple MyelomaPhase 1NCT06084962
A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
A Phase 1 study testing DeepTag-GPRC5D Targeted CAR T-cells in people with Relapse/Refractory Multiple Myeloma, run by He Huang at 1 site in China.
Trial summary
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapse/Refractory Multiple Myeloma
- What is being tested?
- DeepTag-GPRC5D Targeted CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2023to 20 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310000
He Huang, MD, 86-13605714822, hehuangyu@126.com
Yongxian Hu, MD, +8615957162012, huyongxian2000@aliyun.com
About this study
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Read the 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.
- Conditions
- Relapse/Refractory Multiple Myeloma
- Being tested
- DeepTag-GPRC5D Targeted CAR T-cells
- Keywords
- Multiple Myeloma, DeepTag-GPRC5D CAR T-cell
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepTag-GPRC5D Targeted CAR T-cellsBiological
Also called DeepTag-GPRC5D Targeted CAR T-cells injection
Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Administration of DeepTag-GPRC5D Targeted CAR T-cells | Experimental | Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. Receives: Biological: DeepTag-GPRC5D Targeted CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Up to 28 years after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: Up to 2 years after Treatment
Secondary outcomes (3)
Multiple Myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)
Measured: Up to 2 years after Treatment
Progression-free survival (PFS)
The time from randomization or start of study treatment until objective tumor progression or death
Measured: Up to 2 years after Treatment
Duration of remission,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease
Measured: Up to 1 years after Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Sponsor-investigator, He Huang, Zhejiang University
- Investigators
- He Huang, MD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084962
- Sponsor's protocol ID
- TXB2023018
- Status last verified
- Sep 2023
- First submitted
- 10 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06084962
- Acronym / sponsor ID
- TXB2023018
- Conditions
- Relapse/Refractory Multiple Myeloma
- Keywords
- Multiple Myeloma, DeepTag-GPRC5D CAR T-cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- He HuangUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of DeepTag-GPRC5D Targeted CAR T-cells | Experimental | Biological: DeepTag-GPRC5D Targeted CAR T-cellsDose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeepTag-GPRC5D Targeted CAR T-cellsAlso: DeepTag-GPRC5D Targeted CAR T-cells injectionEach subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion | Biological | Administration of DeepTag-GPRC5D Targeted CAR T-cells |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 28 years after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events [Safety and Tolerability]
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang, MD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DeepTag-GPRC5D Targeted CAR T-cells in people with Relapse/Refractory Multiple Myeloma, run by He Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, MD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 28 years after Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.