Study of CART-ddBMCA in Relapsed or Refractory Multiple Myeloma IMMAGINE-1

What's the purpose of this trial?

A Phase II study of CART-ddBCMA for patients with relapsed or refractory multiple myeloma. CART-ddBCMA is a BCMA-directed CAR-T cell therapy.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Age 18 years of age or older and has capacity to give informed consent
  • Relapsed or refractory Multiple Myeloma treated with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody and are refractory to the last line of therapy. For each line, 2 consecutive cycles are required unless the best response after 1 cycle was progressive disease.
  • Documented measurable disease including at least one or more of the following criteria:
    • serum m-protein ≥ 1.0 g/dL
    • urine m-protein ≥ 200 mg/24 hours
    • involved serum free light chain ≥ 10 mg/dL with abnormal kappa/lambda ratio (> 4:1 or < 1:2)
  • ECOG performance status 0-1
  • life expectancy > 12 weeks
  • adequate organ function as defined
  • resolution of AEs prior therapies to Gr 1 or baseline
  • if child bearing potential, must agree to highly effective means of birth control
  • willing to comply with the protocol and up to 15 years long term safety follow-up
  • leukapheresis product can be collected and accepted by manufacturing site.

Exclusion Criteria:

  • plasma cell leukemia or history of plasma cell leukemia
  • treatment with the following therapies:
    • prior systemic treatment for MM within the last 14 days prior to leukapheresis
    • receiving high dose systemic steroid therapy
    • prior treatment with any gene therapy or gene-modified cellular therapy
    • prior BCMA directed therapy
    • autologous stem cell transplant within 3 months prior to leukapheresis
  • patients with solitary plasmacytomas without evidence of other measurable disease are excluded.
  • history of allergy or sensitivity to study drug components (prior history of reaction to DMSO)
  • contraindication to fludarabine or cyclophosphamide
  • severe or uncontrolled intercurrent illness or lab abnormality
  • seropositive for and with evidence of active Hepatitis B or C infection at time of screening or HIV seropositive
  • active CNS involvement by malignancy
  • any sign of active or prior CNS pathology
  • active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission.
  • females who are pregnant or breastfeeding or child bearing potential not willing to agree to effective method of birth control.
  • significant medical condition, laboratory abnormality or psychiatric illness that would prevent participation.

Additional Trial Information

Phase 2

Enrollment: 100 patients (estimated)

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Trial Locations

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Massachusetts General Hospital

Boston, MA

Not Yet Accepting


Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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