Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
Chief Investigator:
Prof Kwee Yong
Recruitment target:
8 to 24
EudraCT number:
Contact details:
Lay summary:
An open label, Phase 1 study evaluating the activity of Modular CAR T for myeloma

Phase1 rolling 6 trial design evaluating safety of a novel BCMA CAR alone (D8 CAR Tcells) and of CAR T cells co-expressing BCMA CAR and a CD19 CAR (D8/CAT CAR Tcells) in patients with relapsed/ refractory Multiple Myeloma (RRMM). Thistrial therefore consists of two initial cohorts. Cohort 1 assesses D8 CAR at 50and 150x106 cells. Cohort 2 assesses a combined D8/CAT CAR and has 2potential doses of 50 and 150x106 cells


BCMA CAR Tcells OR co-expressing BCMA CAR and a CD19 CAR T cells.ATIMP manufacture takes about 15 days. During thisperiod, patients may receive bridging therapy to maintain disease control.Prior to ATIMP infusion patients will receive iv cyclophosphamide 60mg/kg andiv fludarabine 30 mg/m2 on Days -5 to -3. Patients receive the ATIMP via asingle intravenous infusion.Patients will be followed up regularly(with daily, weekly and monthly visits) until 2 years post ATIMP infusion. After 2 years patients will continue to be followed up annually until 10years post ATIMP infusion.

Key inclusion/exclusion criteria:

Key Inclusion:

  1. Age ≥ 18
  2. Relapsed/Refractory Multiple Myeloma
  3. Secretory disease: PP≥5g/L and/or sFLC≥100mg/L of involved light chain with abnormal K:L ratio.
  4. ≥3 prior lines of therapies (including PI (proteasome inhibitor), IMiD (immunomodulatory drugs), antiCD38 antibody
Key Exclusion:

  1.          Previous diagnosis of systemic light chainamyloidosis
  2.        Prior treatment with investigational orapproved gene therapy or cell therapy products 
  3.       Allogeneic stem cell transplant within 12months prior to registration into the study and/or moderate /severe chronicGVHD requiring immunosuppressive therapy and/or systemic steroids
  4.       Active infectious bacterial or viral disease 
  5.       Known CNS involvement
  6.       Medical history including: other neoplasms,autoimmune disease, chronic renal impairment, significant liver disease, DVT orpulmonary embolism
  7.       Patients receiving corticosteroids at a doseof >5 mg prednisolone per day (or equivalent) that cannot be discontinued
  8.       Use of rituximab (or rituximab biosimilar)within the last 3 months prior to CAR T cell infusion or leukapheresis. 
  9.       Localised radiation to asingle site, e.g. for bone pain is permitted at any time
  10.       Patients with any anti-myeloma therapy withinthe last 7 days prior to LD or leukapheresis
  11.       Inability to tolerate leukapheresis
  12.       Life expectancy
  13.       Women who are pregnant or breastfeeding
  14.       Known allergy to albumin or DMSO

Duration of recruitment: 30 Months


To determine the safety and tolerability of anovel BCMA CAR (D8) alone and of CAR T cells engineered to co-express BCMA CARand a CD19 CAR (CAT) in patients with  refractory MM.


To evaluate efficacy of a novel BCMA CAR (D8) aloneand of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR (CAT) in patientswith refractory MM.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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