A Phase 1b/2 Study Of CAR T Cell Therapy Targeting CD19 And BCMA In Participants With Relapsed Or Refractory AL Amyloidosis.

Overview

About this study

Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* 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 disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
* ECOG performance status of 0 to 1
* 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 pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.

Exclusion Criteria:

* 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
* Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator
* Prior therapies:

1. CAR T cell therapy directed at any target
2. Prior BCMA-targeting therapy
3. 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.
* 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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Udit Yadav

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Rahma Warsame

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available