AzTrials
AzTrials

Multiple MyelomaPhase 1/2NCT05521802

A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell in people with Multiple Myeloma, run by Shanghai AbelZeta Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
11 Nov 2022to Jul 2037
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age, male or female patients
  • Relapsed or refractory multiple myeloma
  • Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.
  • Had measurable disease as defined by any of the following criteria:
  • Serum M protein ≥ 0.5g/dL
  • Urine M protein ≥ 200mg/24h
Show all 9Show fewer
  • Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L
  • Adequate liver, renal, bone marrow, and heart function
  • Eastern cooperative oncology group (ECOG) 0-1

Who cannot join

  • Any known allergies to the components or excipients of the C-CAR088 cell product
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis
  • Central nervous system (CNS) involvement
  • Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)
  • Plasma leukemia
  • Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
Show all 11Show fewer
  • Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (HCV) infection; HIV or syphilis infection
  • Severe heart, liver, renal or metabolism disease
  • Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
  • Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
  • History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lugui Qiu, M.D., PH.D. contact

022-23909083

Qiulg@ihcams.ac.cn

An Gang, M.D., PH.D. contact

022-23909171

angang@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology and Blood Diseases Hospital

    Tianjin

    Lugui Qiu, M.D., Ph.D., 022-23909083, Qiulg@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma

This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.

Read the detailed description

The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.

Being tested
B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Medical subject headings
Multiple Myeloma

What participants receive

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

  • B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cellBiological

    Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously

Study groups in NCT05521802
Study groupRoleWhat they receive
C-CAR088ExperimentalAutologous C-CAR088 administered by intravenous (IV) infusion
Receives: Biological: B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell

What is being measured

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

  1. [phase Ib] Incidence and severity of Adverse Events

    Incidence and severity of Adverse Events

    Measured: 24 months

  2. [phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion

    the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion

    Measured: 3 months

Secondary outcomes (16)

  1. Overall response rate (ORR)

    The rate of patients with best response of partial response (PR) or better

    Measured: 24 months

  2. [phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion

    The rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion

    Measured: 3 months

  3. Duration of response (DOR)

    The time from the first documented PR or better response to relapse or death, whichever occurs first

    Measured: 24 months

  4. Time to response (TTR)

    The time from the date of C-CAR088 infusion to the first documented PR or better

    Measured: 24 months

  5. Progression-free survival (PFS)

    The time from the date of C-CAR088 infusion to the date of first documented disease progression or death

    Measured: 24 months

  6. Overall survival (OS)

    The time from the date of C-CAR088 infusion to the date of death

    Measured: 24 months

  7. Minimal residual disease (MRD) negativity rate

    The rate of patients reached MRD negativity

    Measured: 24 months

  8. [phase II] Incidence and severity of Adverse Events

    Incidence and severity of Adverse Events

    Measured: 24 months

  9. Maximal plasma concentration (Cmax)

    maximal plasma concentration of C-CAR088 in peripheral blood

    Measured: 24 months

  10. Time to reach the maximal plasma concentration (Tmax)

    Time to reach the maximal plasma concentration of C-CAR088 in peripheral blood

    Measured: 24 months

  11. Area under the curve within 28 days (AUC0-28d)

    Area under the curve of C-CAR088 in peripheral blood within 28 days post infusion

    Measured: 28 days

  12. Time of last measurable observed concentration (Tlast)

    Time of last measurable observed concentration of C-CAR088 in peripheral blood

    Measured: 24 months

  13. Anti-drug (C-CAR088) antibody

    Presence of serum anti-drug (C-CAR088) antibody

    Measured: 24 months

  14. Serum M protein

    serum M proteins concentration changes over time

    Measured: 24 months

  15. Urine M protein

    Urine M proteins concentration changes over time

    Measured: 24 months

  16. Serum free light chain (sFLC)

    Serum free light chain (sFLC) concentration changes over time

    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 posted30 Aug 2022
  2. Study start11 Nov 2022
  3. Primary completionJul 2024 (estimated)
  4. Study completionJul 2037 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05521802
Sponsor's protocol ID
0203-029
Status last verified
Mar 2023
First submitted
28 Aug 2022
Last updated
24 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell in people with Multiple Myeloma, run by Shanghai AbelZeta Ltd. 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 24 Mar 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 combined 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.

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?

Contact Lugui Qiu, M.D., PH.D. (022-23909083, Qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[phase Ib] Incidence and severity of Adverse Events (time frame: 24 months). 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 NCT05521802.

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 24 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in