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

All Trial Locations

View all clinical trial locations sorted by state.

Massachusetts

Massachusetts General Hospital

Boston, MA

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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