CAR-37 T Cells in Hematologic Malignancies

NCT04136275 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 19-087
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) for treating people with relapsed or refractory CD37+ hematologic malignancies and to understand the side effects when treated with CAR-37 T Cells. \- Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) is an investigational treatment

Conditions

Hematologic Malignancy; Leukemia; Lymphoma; Lymphoma, B-Cell; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Keywords

Leukemia; Hematologic Malignancy; Lymphoma; CAR-T

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity

  2 years

• The occurrence of study related adverse events

  2 years

Secondary Outcomes (3)

• Disease Specific Response

  2 years

• Overall Survival

  2 years

• Progression Free Survival

  2 Years

Study Arms (2)

CAR-37 T cells

EXPERIMENTAL

* CAR-37 will be administered intravenously on day 0 * Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume. * Subjects will receive 3 days of lymphodepleting chemotherapy starting Day -5, before the infusion of CAR-37 T cells on Day 0

Biological: CAR-37 T cells

CAR-37 T cells Dose Escalation

EXPERIMENTAL

* CAR-37 will be administered intravenously on day 0 * Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume. * CAR-37 will undergo dose escalation

Biological: CAR-37 T cells

Interventions

CAR-37 T cells BIOLOGICAL

CAR-37 is an investigational treatment that uses the participant own immune cells, called T cells, to try to kill the cancerous cells

CAR-37 T cells; CAR-37 T cells Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign informed consent form.
• Age ≥18 years of at the time of signing informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Karnofsky ≥60%, see Appendix A)
• Diagnosis of relapsed/refractory (R/R) CD37+ hematologic malignancy as defined as one of the following:
• Mature B cell neoplasms
• Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a
• RR disease after 2 or more prior lines of therapy AND
• of the prior lines of therapy must include an anti-CD20 antibody monotherapy.
• Marginal Zone Lymphoma (MZL) nodal or extranodal:
• R/R disease after 2 or more prior lines of therapy AND
• of the prior lines of therapy must include an anti-CD20 antibody monotherapy
• Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and grade 3b Follicular Lymphoma (FL).
• R/R disease after 2 or more prior lines of therapy OR
• Relapsed following autologous SCT,OR
• Ineligible for autologous SCT.

You may not qualify if:

• Prior CD37 targeted therapies.
• Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.
• Any systemic anti-cancer therapy within 1 weeks of leukapheresis excluding steroids at or below physiologic dosing.
• Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.
• Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.
• Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and/or recent significant traumatic injury.
• Active, uncontrolled, systemic bacterial, viral, or fungal infection.
• Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.
• Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.
• Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.
• Subjects with history of a new pulmonary embolism within 6 months of beginning lymphodepletion.
• Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.
• Pregnant or lactating women

Sponsors & Collaborators

• Marcela V. Maus, M.D.,Ph.D.: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Scarfo I, Ormhoj M, Frigault MJ, Castano AP, Lorrey S, Bouffard AA, van Scoyk A, Rodig SJ, Shay AJ, Aster JC, Preffer FI, Weinstock DM, Maus MV. Anti-CD37 chimeric antigen receptor T cells are active against B- and T-cell lymphomas. Blood. 2018 Oct 4;132(14):1495-1506. doi: 10.1182/blood-2018-04-842708. Epub 2018 Aug 8.

  PMID: 30089630 BACKGROUND

• Frigault MJ, Graham CE, Berger TR, Ritchey J, Horick NK, El-Jawahri A, Scarfo I, Schmidts A, Haradhvala NJ, Wehrli M, Lee WH, Parker AL, Wiggin HR, Bouffard A, Dey A, Leick MB, Katsis K, Elder EL, Dolaher MA, Cook DT, Chekmasova AA, Huang L, Nikiforow S, Daley H, Ritz J, Armant M, Preffer F, DiPersio JF, Nardi V, Chen YB, Gallagher KME, Maus MV. Phase 1 study of CAR-37 T cells in patients with relapsed or refractory CD37+ lymphoid malignancies. Blood. 2024 Sep 12;144(11):1153-1167. doi: 10.1182/blood.2024024104.

  PMID: 38781564 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Lymphoma, B-Cell; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Matthew J. Frigault, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 23, 2019
• Study Start: June 19, 2020
• Primary Completion: September 30, 2023
• Study Completion: March 1, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)