A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.

Korábbi kezelés

• Prior therapies:
  • CAR T cell therapy directed at any target
  • Prior BCMA-targeting therapy
  • Prior treatment with any FDA approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months.
• Toxicity from previous anti-cancer or anti-PC-directed therapy did not resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.

Más betegség

• Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator

Egyéb

• Have any other form of amyloidosis other than AL amyloidosis
• Mayo Stage IIIb AL amyloidosis
• Oxygen saturation < 95% on room air
• Systolic blood pressure <100mmHg
• NYHA class III or IV
• Active plasma cell leukemia at the time of screening
• Symptomatic multiple myeloma (defined as clonal bone marrow plasma cells ≥10% plus at least one myeloma-defining event per IMWG 2014)

• Confirmed histopathological diagnosis of AL amyloidosis
• One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
• Measurable hematologic disease: dFLC > 20 mg/L or serum M-protein > 5g/L
• Relapsed or refractory disease with a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
• ECOG performance status of 0 to 2
• Must be able and willing to adhere to the study visit schedule and other protocol requirements
• Women of child-bearing potential (WCBP) must have a negative serum and/or urine pregnancy test result prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use highly effective methods of birth control throughout the study.