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Multiple MyelomaPhase 2NCT05509530

Safety and Efficacy of Anti-BCMA/GPRC5D CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma(rr/MM)

A Phase 2 study testing anti-BCMA/GPRC5D CAR-T CELL in people with Multiple Myeloma, run by Xuzhou Medical 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/GPRC5D CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture Anti-BCMA/GPRC5D chimeric antigen receptor (CAR) modified T cells. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
anti-BCMA/GPRC5D CAR-T CELL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 May 2022to 1 May 2025
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age and gender: 18 years old <= age <= 70 years old, gender unlimited, signing informed consent voluntarily;
  • According to the classification definition of IMWG standard, the diagnosis of plasmacytoma is multiple myeloma, plasmacytic leukemia, poems syndrome, monoclonal IMMUNOGLOBULINEMIA, primary macroglobulinemia or primary amyloidosis which are invalid or relapsed after at least three-line treatment (including chemotherapy based on bortezomib and / or lenalidomide);
  • BCMA and GPRC5D were positive on the surface of plasma membrane;
  • The patients could not receive the treatment of HSCT, or the relapse after HSCT was judged to need treatment by researchers;
  • ECOG score is 0 or 1;
  • Expected survival time >= 12 weeks;
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  • The subjects must have proper organ function and meet all the following laboratory test results before entering the group
  • Blood routine test: neutrophil >= 1.0 x 10^9 / L; hemoglobin >= 70 g / L; platelet >= 50 x 10^9 / L;
  • Liver function: ALT and AST <= 2.5 x ULN; total bilirubin <= 1.5 x ULN;
  • Renal function: serum creatinine <= 2.5 x ULN; or creatinine clearance calculated according to Cockcroft Gault formula Rate CrCl >= 60 ml / min.
  • Electrolyte: blood potassium >= 3.0 mmol / L; blood calcium >= 2.0 mmol / L; blood magnesium >= 0.5 mmol / L;
  • Coagulation function: fibrinogen >= 1.0g/l; activated partial thromboplastin time (APTT) <= Keywords ULN + 10s; prothrombin time (PT) < ULN + 3S;
  • The subjects should be willing to provide effective diagnosis evidence or bone marrow examination before treatment, and bone marrow or effective examination after treatment;
  • Women of childbearing age and fertile male subjects must take one of the following effective contraceptive measures from signing informed consent until one year after anti-BCMA/GPRC5D CAR-T cell transfusion: abstinence, double barrier contraceptive method, IUD, hormone contraceptive;
  • Male subjects were forbidden to donate sperm from signing the informed consent until one year after anti-BCMA/GPRC5D CAR-T cell transfusion;
  • Sign informed consent
  • The subject must have informed consent to the test before the test, and be voluntary by himself (or his legal representative) signed the written informed consent;
  • The subjects or their legal representatives can communicate well with the researchers and follow the protocol to complete the test.

Who cannot join

  • Previous treatment history
  • Received hematopoietic stem cell transplantation within 2 months before the start of administration, or within the screening period after transplantation, immunosuppressive therapy was used because of graft-versus-host disease;
  • Patients who had received chemotherapy, immunotherapy, radiotherapy and major surgery within 4 weeks before the start of administration;
  • Those who received the live vaccine within 4 weeks before the start of administration and / or planned to receive the live vaccine after the trial;
  • Those who have received clinical trial drug treatment or are participating in other clinical trials within 4 weeks before drug administration;
  • History of disease and operation
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  • Patients with central nervous system invasion by plasmacytoma;
  • Hypertension and drug treatment can not get good control (blood pressure > 140 / 90 mmHg);
  • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) < 50%;
  • Arrhythmia with NCI CTCAE 5.0 grade >= 2, or male QTc > 450 ms, female QTc > 470 MS (QTc was calculated by the friderica correction formula QTc = QT / rr0.33); patients with a history of tip torsion or congenital QT prolongation syndrome;
  • Patients with any of the following diseases within 12 months before administration: myocardial infarction, severe or unstable heart, patients with colic, coronary artery bypass or peripheral artery bypass grafting, congestive heart failure, cerebrovascular events (including transient ischemic attack), etc;
  • During the screening period, the researchers judged that there were uncontrollable and active infectious diseases;
  • People infected with human immunodeficiency virus (HIV);
  • HBsAg was positive and in the active phase of hepatitis B (HBV DNA quantity >= 1.00 x 10^2 copies / ml);
  • Hepatitis C antibody (anti HCV) was positive and was in the active phase of hepatitis C (hepatitis C RNA was not in the normal mode)Perimetric value);
  • The researchers judged patients with severe electrolyte disorder;
  • Patients with a clear tendency of gastrointestinal bleeding, including the following: local active ulcer focus, and stool occult blood (>= + +); patients with a history of black stool and hematemesis within 2 months; researchers believe that digestion may occur Patients with massive bleeding of the Tao;
  • Patients with a history of solid organ transplantation;
  • The investigator or sponsor thinks that he / she has other acute, serious or chronic medical or psychological diseases and is not suitable for participation Add clinical trial;
  • Pregnant and nursing women
  • Prohibited treatment and / or medication
  • At the same time, other anti-tumor drugs, including traditional Chinese medicine, were used;
  • At the same time, take drugs that can prolong QT interval (including class IA and III antiarrhythmic drugs);
  • Those who need to receive oxygen every day;
  • Long term use of corticosteroids (except for local inhalation);
  • others
  • Those who have a history of psychoactive drug abuse and are unable to give up or have mental disorders;
  • Habitually drink grapefruit juice or excessive tea, coffee and / or caffeinated beverages during the trial Unable to give up;
  • According to the judgment of the researchers, there are serious concomitant diseases endangering the safety of patients or affecting the completion of the trialillnes.

Trial locations and contacts

1 site in 1 country.

Kailin Xu, M.D., Ph.D. contact

15162166166

lihmd@163.com

Junnian Zheng, M.D., Ph.D. contact

China1 site, 1 recruiting

  • Kailin Xu

    Xuzhou, Jiangsu, 221000

    Kailin Xu, M.D., Ph.D., 15162166166, lihmd@163.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety Study of Anti-BCMA/GPRC5D CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/GPRC5D CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture Anti-BCMA/GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/GPRC5D infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Read the detailed description

This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-BCMA/GPRC5D CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture Anti-BCMA/GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/GPRC5D infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.

Being tested
anti-BCMA/GPRC5D CAR-T CELL
Keywords
Multiple Myeloma, BCMA, GPRC5D
Medical subject headings
Multiple Myeloma

What participants receive

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

  • anti-BCMA/GPRC5D CAR-T CELLOther

    anti-BCMA/GPRC5D autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy

Study groups in NCT05509530
Study groupRoleWhat they receive
anti BCMA/GPRC5D CAR-TExperimentalEnrolled patients will receive prespecified dose of autologous anti BCMA/GPRC5D CAR-T cells.
Receives: Other: anti-BCMA/GPRC5D CAR-T CELL

What is being measured

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

  1. Number of participants with Adverse Events, with abnormal vital signs, abnormal physical examination findings, abnormal laboratory test results, abnormal ECGs and abnormal echocardiograms.

    Measured: 12 months

Secondary outcomes (4)

  1. overall response rate (ORR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM

    Percentage of subjects who achieved a CR, VGR, PR according to IMWG Uniform Response Criteria for Multiple Myeloma (MM)

    Measured: 24 months

  2. complete response (CR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM

    Percentage of subjects who achieved a CR according to IMWG Uniform Response Criteria for Multiple Myeloma (MM)

    Measured: 24 months

  3. very good partial response (VGPR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM

    Percentage of subjects who achieved a VGPR according to IMWG Uniform Response Criteria for Multiple Myeloma (MM)

    Measured: 24 months

  4. partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM

    Percentage of subjects who achieved a PR according to IMWG Uniform Response Criteria for Multiple Myeloma (MM)

    Measured: 24 months

Timeline

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

  1. First posted22 Aug 2022
  2. Study start1 May 2022
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 May 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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05509530
Sponsor's protocol ID
XYFY2022-KL118-01
Status last verified
Aug 2022
First submitted
2 Aug 2022
Last updated
22 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou D, Qi Y, Ma S, Sun Q, Gu W, Xia J, Zhang X, Chen W, Cheng H, Qi K, Zhu F, Xia F, Zhu L, Li H, Zhang H, Yan D, Qiu T, Zhang Y, Peng S, Sang W, Li D, Chang AH, Pan B, Yan Z. Anti-BCMA/GPRC5D CAR T cells in patients with relapsed or refractory multiple myeloma who have extraosseous extramedullary disease. Blood. 2026 Aug 13;148(7):831-840. doi: 10.1182/blood.2026033506.

    PubMed 42166352

  • Zhou D, Sun Q, Xia J, Gu W, Qian J, Zhuang W, Yan Z, Cheng H, Chen W, Zhu F, Qi K, Li D, Sang W, Zhu L, Ma S, Li H, Zhang H, Qiu T, Yan D, Zhang Y, Peng S, Chang AH, Xu K, Li Z. Anti-BCMA/GPRC5D bispecific CAR T cells in patients with relapsed or refractory multiple myeloma: a single-arm, single-centre, phase 1 trial. Lancet Haematol. 2024 Oct;11(10):e751-e760. doi: 10.1016/S2352-3026(24)00176-5. Epub 2024 Jul 23.

    PubMed 39059405

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-BCMA/GPRC5D CAR-T CELL in people with Multiple Myeloma, run by Xuzhou Medical 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?

The sponsor lists 18 inclusion and 29 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 22 Aug 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Kailin Xu, M.D., Ph.D. (15162166166, lihmd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events, with abnormal vital signs, abnormal physical examination findings, abnormal laboratory test results, abnormal ECGs and abnormal echocardiograms. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509530, which also lists 2 linked publications.

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 22 Aug 2022.

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