Health TrialsbyHealthPanel

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

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai AbelZeta Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Serum M protein ≥ 0.5g/dL

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

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

Treatment groups

92 Participants
are divided into 1 treatment group
Group A: C-CAR088Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

[phase Ib] Incidence and severity of Adverse Events

Incidence and severity of Adverse Events

Time frame
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

Time frame
3 months

Secondary outcomes

1

Overall response rate (ORR)

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

Time frame
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

Time frame
3 months
3

Duration of response (DOR)

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

Time frame
24 months
4

Time to response (TTR)

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

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai AbelZeta Ltd.

Lead sponsor

Source ClinicalTrials.gov
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