A Study to Evaluate the Safety and Effectiveness of ALLO-501A CAR T Cell Therapy in Adults with Relapsed/ Refractory Large B Cell Lymphoma

Overview

About this study

The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).

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:

For subjects with LBCL:

- Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at
last relapse per WHO 2017

- At least 1 measurable lesion at time of enrollment

- Relapsed or refractory disease after at least 2 lines of chemotherapy

- Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening
(Note: Only applicable for Phase 2)

For subjects with CLL/SLL:

- Diagnosis of CLL/SLL

- Relapsed/refractory disease

- Subjects relapsed/refractory to BTKi therapy and high-risk disease

- Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2
inhibitor (venetoclax)

- At least 1 measurable lesion at time of enrollment

For all subjects:

- Male or female subjects ≥18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- Adequate hematological, renal, and liver function

Exclusion Criteria:

- Active central nervous system (CNS) involvement by malignancy

- Current thyroid disorder (including hyperthyroidism), except for subjects with
hypothyroidism controlled on a stable dose of hormone replacement therapy

- Any other active malignancies that required systemic treatment within 3 years prior to
enrollment

- Radiation therapy within 2 weeks prior to ALLO-647

- Prior irradiation to >25% of the bone marrow

- Hypocellular bone marrow for age by institutional standard as determined from a bone
marrow biopsy performed at time of screening (Note: Only applicable for Phase 2).

- Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)

- Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/14/2024. Questions regarding updates should be directed to the study team contact.

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

Javier Munoz, M.D., M.B.A.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20510895

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