NCT05521802 A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
| NCT ID | NCT05521802 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai AbelZeta Ltd. |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2022-11-11 |
| Primary Completion | 2024-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 92 participants in total. It began in 2022-11-11 with a primary completion date of 2024-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria * ≥ 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 * 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 Exclusion Criteria * 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 * 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
Contact & Investigator
Lugui Qiu
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT05521802 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05521802 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05521802 currently recruiting?
Yes, NCT05521802 is actively recruiting participants. Contact the research team at Qiulg@ihcams.ac.cn for enrollment information.
Where is the NCT05521802 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05521802 clinical trial?
NCT05521802 is sponsored by Shanghai AbelZeta Ltd.. The principal investigator is Lugui Qiu at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 92 participants.