A Phase 1b/2 Study of AZD0120 (also known as GC012F), a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Participants with Relapsed or Refractory AL Amyloidosis

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Phase 1b

Primary Objectives:

To evaluate the safety and tolerability of AZD0120, and determine the RP2D of AZD0120 in participants with AL amyloidosis

Secondary Objectives:

To evaluate the efficacy of AZD0120 in participants with AL amyloidosis
To characterize the CK of AZD0120 in peripheral blood following a single-dose of AZD0120 in participants with AL amyloidosis
To assess immunogenicity of AZD0120 in participants with AL amyloidosis

Phase 2

Primary Objectives:

Secondary Objectives:

To further evaluate the efficacy of AZD0120 in participants with AL amyloidosis
To characterize the safety of AZD0120 in participants with AL amyloidosis
To characterize the CK of AZD0120 in peripheral blood following a single-dose of AZD0120 in participants with AL amyloidosis
To assess immunogenicity of AZD0120 in participants with AL amyloidosis
To assess the effect of AZD0120 on overall health status in participants with AL amyloidosis

Eligibility

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:

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.
Active plasma cell leukemia at the time of screening

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices