Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXi'an No.3 Hospital

About this trial

The purpose of this clinical trial is to learn if allogeneic cord blood-derived CAR-T cell drug works to treat Multiple Myeloma (MM) including Bone-related extramedullary (EMB) disease and extramedullary extraosseous disease(EME) in adults. It will also learn about the safety of the allogeneic cord blood-derived CAR-T cell drug. The main questions it aims to answer are:

1. What adverse events occur and the incidence rate of DLTs within 28 days and UCAR-T-related AEs within 28 days after the allogeneic cord blood-derived CAR-T cell injection for multiple myeloma (MM)? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the overall responserate (ORR), including stringent complete response (sCR), completeresponse (CR),very good partial response (VGPR), partial response (PR), minimal Response (MR) and DOR, PFS, RFS, OS?

Participants will:

1. be pretreated with FC regimen, fludarabine (30mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300\~500 mg/m²/d, day -5,-4, and -3). 2. rest for 2 days on Day-2 and Day-1. Tumor burden should be re-evaluated and chemotherapy side effects assessment. 3. receive allogeneic cord blood-derived CAR-T cells infusion 4. Visit the clinic at D28, 1 month, 2 months, 3 months, 4 months, 6 months, 9 months and 1 year after CAR-T cells infusion.

Eligibility criteria

Qualifiers

1.Aged 18 to 75 years (inclusive of boundary values), with no limitation on gender;

S: Bone marrow monoclonal plasma cell percentage ≥60%;

Li: Ratio of involved to uninvolved serum free light chain ≥100 (with the involved light chain value being at least ≥100 mg/L);

M: MRI detection of >1 focal bone lesion larger than 5 mm.

Disqualifiers

2.Lactating women;

3.Unwillingness to undergo follow-up for 15 years;

4.Poor compliance with the study procedures;

5.Individuals under legal guardianship or conservatorship;

Trial design

Treatments tested in this trial

  • allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

Xi'an No.3 Hospital

Lead sponsor

Ucello Therapeutics Co., Limited

Collaborator