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ORR,OS,PFSEarly Phase 1NCT06574958

Clinical Study of CD38\CS1 Chimeric Antigen Receptor T Cells in the Treatment of Refractory/Recurrent Multiple Myeloma

A Early Phase 1 study testing CD38/CS1 injection in people with ORR,OS,PFS, run by The Second Hospital of Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators developed a dual-target CAR-T targeting CD38 and CS1. Previous experimental results showed that the investigators double-target CAR-T not only had a good killing effect on CD38/CS1 double-positive tumor cells, but also had a high killing rate on CD38 or CS1 single-positive tumor cells. Read more about this study

Who is it for?
Ages 15 to 80 years
Conditions the study is for
ORR,OS,PFS
What is being tested?
CD38/CS1 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
30 Apr 2024to 15 Jan 2025
Phase
Early 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 15 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Inclusion Criteria:1. Relapsed, refractory, drug-resistant MM. 2. MM patients who have not achieved CR in 4 cycles of standard treatment. 3. Age over 15 and under 75. 4. KPS≥50 or ECOG score ≤2 points and expected survival greater than 3 months. 5. No systemic therapy (except systemic immune checkpoint suppression or activation therapy) for at least 2 weeks or at least 5 drug half-lives (whichever is shorter) prior to apheresis. 6. The absolute number of neutrophils was > 1.0x109 /L. 7. Absolute number of platelets > 50x109 /L. 8. Absolute number of lymphocytes ≥ 0.15x109 /L. 9. ALT/AST < 3 times the normal value. 10. Total bilirubin < 1.5mg/dl. 11. Creatinine < 2.5mg/dl, or creatinine clearance ≥60 mL/min/1.73 m2. 12. Cardiac ejection fraction ≥ 45%, echocardiography (ECHO) showed no pericardial effusion, electrocardiogram (ECG) was normal 13. Blood oxygen saturation ≥92% under normal conditions. 14. Women of childbearing age who had a negative urine pregnancy test before the start of dosing and consented to effective contraceptive use during the trial period until the last follow-up visit. 15. Volunteer to participate in this experiment and sign the informed consent.

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Exclusion Criteria:1. Patients with expected survival of less than 3 months. 2. Patients whose disease progression was so rapid that a complete treatment cycle could not be ensured according to the investigator at the time of enrollment. 3. Patients with primary tumors other than melanoma skin cancer (e.g. cervical cancer, bladder cancer, breast cancer) (unless cured for more than 3 years). 4. Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation. 5. Patients who test positive for HIV, HBV and HCV. 6. Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases. 7. Patients with myocardial infection, cardiac angiography or stent, active angina pectoris or other significant clinical symptoms, or with cardiogenic asthma or cardiovascular plasma cell infiltration in the 12 months prior to enrollment. 8. People who are receiving anticoagulant therapy or have severe coagulation disorders. 9. According to the judgment of the researcher, the drug treatment that the patient is receiving will affect the safety and effectiveness study of this project. 10. Patients with allergy or history of allergy to the biologics used in this project. 11. Pregnant or lactating women. 12. Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids). 13. The efficiency of T cell transduction by replication-deficient lentivirus is less than 30%, or the amplification ability is insufficient (times) in response to CD3 / CD28 co-stimulatory signals. 14. Patients with other uncontrolled diseases deemed unsuitable by the researchers. 15. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results. 16. Patients who are also participating in other clinical studies.

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Trial locations and contacts

1 site in 1 country.

China1 site
  • Second Hospital of Shandong University

    Shandong, Shandong, 250000

Other trials in China

About this study

Official title: Professor of Medicine Second Hospital of Shandong University

The investigators developed a dual-target CAR-T targeting CD38 and CS1. Previous experimental results showed that the investigators double-target CAR-T not only had a good killing effect on CD38/CS1 double-positive tumor cells, but also had a high killing rate on CD38 or CS1 single-positive tumor cells. The investigators further study also found that the killing rate of the investigators dual-target CAR-T after mixing CD38 and CS1 monoyang tumor cells was over 80%. The advantage of the investigators dual-target CAR-T product is that the killing effect on single-yang, double-yang and single-yang mixed tumors is stable, and the killing rate is above 80% (see Figure 1). It has a wide killing range and can effectively reduce the phenomenon of tumor immune escape. Therefore, the investigators dual CAR products have good advantages and development potential.

Conditions
ORR,OS,PFS
Being tested
CD38/CS1 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD38/CS1 injectionBiological

    Dosage form and specification: injection, 40mL/ dose, according to the number of positive cells 1×106/kg Properties: Colorless or slightly light white clear liquid Prescription composition: CD38/CS1 CAR T cells, 2.5% human blood albumin, 0.9% sodium chloride injection.

    Administration mode: intravenous injection Storage condition: 2-8℃ for 8h Mechanism of action :38WP as a dual-target CAR T cell therapy, compared with single-target CAR T cell therapy, its advantage is that it can reduce antigen escape of tumor cells.

Study groups in NCT06574958
Study groupRoleWhat they receive
refractory or relapsed MMExperimentalNot described
Receives: Biological: CD38/CS1 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    sCR、CR、VGPR、PR

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start30 Apr 2024
  3. Primary completion15 Jan 2025 (estimated)
  4. Study completion15 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
10
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574958
Sponsor's protocol ID
2024 CD38/CS1 T cell of MM
Status last verified
Aug 2024
First submitted
13 Aug 2024
Last updated
28 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD38/CS1 injection in people with ORR,OS,PFS, run by The Second Hospital of Shandong University 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?

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 28 Aug 2024. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: one year). 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 28 Aug 2024.

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