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Plasma Cell LeukemiaPhase 2NCT05870917

A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia

A Phase 2 study testing anti-BCMA CAR-T and VRD-based Regimen in people with Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Plasma Cell Leukemia
What is being tested?
anti-BCMA CAR-T and VRD-based Regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
23 May 2023to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Age ≥ 18 years and ≤ 65 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Life expectancy at least 3 months
  • Definitive diagnosis of pPCL: meet the diagnosis criteria of multiple myeloma (refer to the Chinese guidelines for the diagnosis and management of multiple myeloma (revised 2022) criteria) and meeting any of the following:
  • the proportion of tumor plasma cells in peripheral blood leukocytes ≥ 5%;
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  • absolute value of peripheral blood tumorigenic plasma cells exceeds 2×10^9/L.
  • Patients have not received previous anti-myeloma related therapy.
  • Measurable disease, as defined by at lease one of the following:
  • Serum monoclonal paraprotein (M-protein) level ≥5g/L.
  • urine M-protein level ≥200 mg/24 hours.
  • If the serum and urine M-protein are unmeasurable, abnormal serum free light chain (FLC) ratio and affected FLC ≥10 mg/dL.
  • Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
  • Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : ANC ≥ 1.0 x 10^9/L, PLT ≥ 50 x 10^9/L.
  • All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria:
  • Total bilirubin<1.5 x upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST);
  • Creatinine clearance ≥ 50mL/min (calculated using Cockroft-Gault formula).
  • Patients must be able to take prophylactic anticoagulant therapy as recommended by the study.
  • The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter.
  • Willing and able to complete the study procedures and follow-up examinations.

Who cannot join

  • Secondary plasma cell leukemia.
  • With central nervous system (CNS) involvement.
  • Ineligible for autologous stem cell transplantation, such as severe cardiopulmonary disorders.
  • Known intolerant, allergic, or resistant to glucocorticoids, bortezomib, lenalidomide, Venetoclax, Selinexor and BCMA-CART cellular products.
  • Patients had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period.
  • Patients with unstable or active cardiovascular system disease, meeting any of the following:
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  • Unstable angina pectoris, symptomatic myocardial ischaemia, myocardial infarction or coronary artery reconstruction within 180 days prior to the first dose.
  • Uncontrolled hypertension (>140/90 mmHg with blood pressure fluctuations of more than 180/100 mmHg over a 6-month period).
  • Uncontrolled and clinically significant conduction abnormalities (e.g. patients with ventricular arrhythmias controlled by antiarrhythmic medication), not excluding patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior bundle branch block/right bundle branch block (LAFB/RBBB)).
  • Congestive heart failure (CHF) classification ≥ grade 3 as defined by the New York Heart Association (NYHA).
  • Left ventricular ejection fraction (LVEF) <50% on echocardiography.
  • History of stroke or intracranial haemorrhage within 12 months prior to screening.
  • Presence of a serious thrombotic event prior to treatment.
  • Known positive serology for HIV or HIV seropositivity.
  • Active hepatitis B or C infection. Screening requires serologic testing for hepatitis. If hepatitis B surface antigen and hepatitis B core antibody were positive, a negative DNA polymerase chain reaction (PCR) result was needed before enrollment (after anti-hepatitis B therapy, a negative DNA polymerase PCR result was confirmed before enrollment). If the hepatitis C antibody was positive, the RNA PCR test should be negative prior to enrollment.
  • Ongoing active infection.
  • Prior history of malignancies, unless free of the disease for ≥ 5 years.
  • Pregnant or breast feeding females.
  • Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of the studied treatment medication.
  • According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent.
  • Necessary medication or supportive therapy is contraindicated with study treatment.
  • Any other medical condition or comorbidity that might interfere with subject's participation.
  • Patients undergoing other experimental therapies.
  • Patients are not willing to or cannot comply with study scheme.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin

Other trials in China

About this study

Official title: A Prospective, Single-center, Phase II Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Newly Diagosed Primary Plasma Cell Leukemia

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia.

Read the detailed description

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of treatment with VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) in combination with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia. Patients receive 3-4 cycles of induction therapy with VRD-based regimen followed by the first infusion of CAR-T cells. Patients then received 2-3 cycles of VR-based consolidation therapy, followed by ASCT and the second infusion of CAR-T cells. And R-based maintenance starts on day 100 after ASCT.

Being tested
anti-BCMA CAR-T, VRD-based Regimen
Medical subject headings
Leukemia, Plasma Cell

What participants receive

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

  • anti-BCMA CAR-TBiological

    Patients receive two sequential intravenous infusions of one of two BCMA-directed autologous CAR T-cell products, with the same product used for both infusions in each patient: YK-BB-002, (2-4) × 10⁶ ± 20% CAR-positive T cells/kg; Equecabtagene autoleucel: Planned dose of 1.0 × 10⁶ CAR-positive T cells/kg.

  • VRD-based RegimenDrug

    Bortezomib, Lenalidomide and Dexamethasone

Study groups in NCT05870917
Study groupRoleWhat they receive
VRD-based regimen Combined CART-ASCT-CART2ExperimentalVRD：Bortezomib, Lenalidomide and Dexamethasone Bortezomib SC 1.3mg/sqm on day 1,8,15,22, Lenalidomide oral 25 mg on day 1-21, and Dexamethasone 40mg on day 1,8,15,22 in a 28-day cycle. Autologous BCMA-directed CAR T cells: two sequential intravenous infusions of the same product in each patient, either YK-BB-002 at a target dose of (2-4) × 10⁶ ± 20% CAR-positive T cells/kg or equecabtagene autoleucel at a planned dose of 1.0 × 10⁶ CAR-positive T cells/kg. Participants will receive VRD-based induction, first CAR-T infusion, VR-based consolidation, ASCT followed by the second CAR-T infusion, and R-based maintenance.
Receives: Biological: anti-BCMA CAR-T; Drug: VRD-based Regimen

What is being measured

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

  1. Progression free survival (PFS)

    Is defined as time from first induction date to first documentation of PD, or death due to any cause, whichever occurs first.

    Measured: 1 year

  2. Safety and Tolerability

    The incidence of treatment-emergent adverse events (TEAEs)

    Measured: 2 year

Secondary outcomes (5)

  1. Complete response rate (CRR)

    CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to IMWG criteria

    Measured: after induction therapy, 1 and 3 month after first CAR-T cell infusion, 1 and 3 month after the second CAR-T cell infusion

  2. Overall survival (OS)

    Is defined as time from first induction date to time of death due to any cause

    Measured: 2 year

  3. MRD-negative Rate

    MRD negative by flow cytometry

    Measured: after induction therapy, 1 and 3 month after first CAR-T cell infusion, 1 and 3 month after the second CAR-T cell infusion

  4. Duration of Remission (DOR)

    Duration from the first evaluation of at least partial remission (PR) to the onset of disease progression or death due to disease progression (whichever occurs first)

    Measured: 2 year

  5. Overall response rate (ORR)

    ORR (including sCR/CR/VGPR/PR, based on IMWG criteria)

    Measured: after induction therapy, 1 and 3 month after first CAR-T cell infusion, 1 and 3 month after the second CAR-T cell infusion

Timeline

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

  1. First posted23 May 2023
  2. Study start23 May 2023
  3. Primary completion18 Sep 2025
  4. Study completionApr 2027 (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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05870917
Sponsor's protocol ID
IIT2022064
Status last verified
Oct 2026
First submitted
29 Apr 2023
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-BCMA CAR-T and VRD-based Regimen in people with Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 21 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression free survival (PFS) (time frame: 1 year). 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?

On the ClinicalTrials.gov record for NCT05870917.

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 4 Nov 2026.

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