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SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

SGN-CD19A

Eric Feldman, MD

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).

A Safety Study of SGN-CD19A for Leukemia and Lymphoma

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

Seagen Inc.

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Mantle Cell Lymphoma

Follicular Lymphoma

Diffuse Large B-Cell Lymphoma

SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

Ana Kostic, MD

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)

A Safety Study of SGN-CD19A for B-Cell Lymphoma

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Antipyretics

Analgesics

Antirheumatic Agents

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Fludarabine

Fludarabine phosphate

Acetaminophen

Rituximab

Alemtuzumab

Diphenhydramine

Promethazine

Antineoplastic Agents, Immunological

Immunologic Factors

25 mg/m2/day for 5 days every 28 days (Week 2,6,10,14, 18,and 22) will be administered by IV over 10-30 minutes. (Fludarabine should be given AFTER rituximab on all days on which both drugs will be administered.)

Day 1, week 2 of cycle 1 rituximab 100 mg will be administered by IV, without dose escalation, over 4 hours (rate: 25 mg/hr). Day 3, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 50 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.

* On Day 5, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 100 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
* Rituximab 375 mg/m2 will be repeated on Day 1 of Week 6, 10, 14, 18, and 22. During these treatments, acetaminophen and diphenhydramine prophylactic treatment is left to the discretion of the treating physician.

The dose of alemtuzumab will be escalated during Week 1 of therapy. On Day 1 of Week 1, a dose of 3 mg should be administered IV over 2-hours. If this dose is well tolerated(grade 2 or less infusion or skin related toxicity), then the dose on Day 2 can be increased to 10 mg IV over 2 hours. If this dose is well tolerated, then the dose on Day 3 will be increased to 30 mg IV over 2-hours, and if tolerated, then day 5 and all subsequent alemtuzumab doses will be 30 mg. Vital signs (blood pressure, pulse, respiration rate,temperature, and O2 saturation) and skin assessment should be assessed at baseline, 1-hour, and 1-hour post administration during week 1 and 2. Following successful escalation to 30 mg of alemtuzumab, all subsequent doses of alemtuzumab will be 30 mg administered on the second day of fludarabine therapy (week 2,6,10,14,18,and 22).

John C. Byrd, M.D.

This purpose of this study is to assess the toxicity and the rate of complete and overall response using fludarabine, rituximab, and alemtuzumab to treat patients with B-chronic lymphocytic leukemia or small lymphocytic leukemia who have received previous treatment.

Immunotherapy, or treatments that work by boosting immune function in the body, such as monoclonal antibodies have shown some efficacy against different types of leukemia. Researchers have learned to manufacture antibodies outside of the human body that can bind to specific targets in cancer cells. Monoclonal antibodies are designed to recognize different proteins on specific cancer cells. The current study combines two monoclonal antibodies, rituximab and fludarabine. Rituximab attaches to a protein called the CD20 antigen that is found almost exclusively on the surface of B-cells with leukemia. Once rituximab attaches to the protein, the immune system activates to kill the malignant B-cells. Alemtuzumab works in a similar way by attaching with the CD25 antigen and also has activity in patients with p53 gene mutations. Previous studies indicate that both rituximab and alemtuzumab separately have some efficacy against lymphocytic leukemia. Research has also shown that fludarabine works against the disease. Rituximab and fludarabine in combination appear to have a high response rate in patients. Researchers are seeking to improve efficacy data by adding alemtuzumab to the combination of rituximab and fludarabine in this study.

This study will evaluate the safety and efficacy of fludarabine, rituximab, and alemtuzumab in patients with previously treated B-cell lymphocytic leukemia and small lymphocytic leukemia. Blood and bone marrow tests will assess genetic features associated with response to therapy, immune recovery, mechanisms of alemtuzumab's signaling, routes of drug resistance, and traces of residual disease following complete response in patients.

Patients in this study will receive fludarabine, rituximab, and alemtuzumab. These drugs will be administered through intravenous infusions. The treatment period will last 22 weeks. Fludarabine will not be given during week one, 5 days during week 2, and 5 days during weeks 6, 10, 14, 18, and 22. Rituximab will not be given during week one, 3 times the second week, and day one of weeks 6, 10, 14, 18, and 22. Alemtuzumab will be given 3 times during week one, once during week 2, and day 2 of weeks 6, 10, 14, 18, and 22. The dosage amount of rituximab and alemtuzumab will be increased depending upon the degree of side effects. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Fludarabine, Rituximab, and Alemtuzumab for B-Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Feasibility/Phase II Trial of Fludarabine, Rituximab, and Alemtuzumab for Previously Treated B-Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Ohio State University Comprehensive Cancer Center

Principal Investigator

Other Dietary Supplements

Immunomodulating Agents

Benzocaine

Tannic Acid

ALETA-001 will be administered intravenously (IV) every two weeks.

ALETA-001

Emma Ingleson

Sridhar Chaganti, Dr

Ram Malladi, Dr

Cathy Burton, Dr

William Townsend, Dr

Jane Norman, Dr

Adam Gibb, Dr

Carlos Arias, Dr

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in patients with relapsed non-Hodgkin lymphoma (NHL) who have failed to optimally respond to prior treatment with anti-CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 will be evaluated in Phase I in order to define a recommended dosing level and schedule for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

A Cancer Research Phase I/ II Trial of ALETA-001 in Participants Who Do Not Achieve or Maintain an Optimal Response to Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Malignancies

Individual de-identified patient data that underlie the results reported will be shared with researchers whose proposed use of the data is approved by a review committee of the Sponsor.

Determine a dose level that is deemed tolerable based on available safety and pharmacodynamic data.

DLTs will be assessed up to Day 28 and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the 28 days of the first dose of ALETA-001.

Related AEs are those considered by the investigator to be possibly, probably or highly probably related to ALETA-001. Events of cytokine release syndrome (CRS) and immune effector cell mediated neurotoxicity (ICANS) are graded according to the American Society for Transplantation and Cellular Therapy grading criteria. All other AEs are graded according to the Common Terminology Criteria for AEs (CTCAE) Version 5.0.

Best Overall Response according to Lugano criteria (Cheson, Journal of Clinical Oncology, 2014), the number of participants taking part in the Dose Expansion Phase with best overall response of complete response (CR), partial response (PR), no response or stable disease (SD/NR), and progressive disease (PD).

Median PFS measured from first dose of ALETA-001 to date of progression according to Lugano criteria or date of death without a previous progression recorded.

Median TTP measured from first dose of ALETA-001 to date of progression according to Lugano criteria. Participants who die without recorded progression will be censored.

Median OS measured from first dose of ALETA-001 to date of death due to any cause or to the date of censoring at the last time the participant was known to be alive.

Best Overall Response according to Lugano criteria, the number of participants taking part in the Safety Lead-in Phase with best overall response of complete response (CR), partial response (PR), no response or stable disease (SD), and progressive disease (PD).

Measurement of Cmax of ALETA-001 as appropriate.

Measurement of t1/2 of ALETA-001 as appropriate.

Measurement of AUC of ALETA-001 as appropriate.

Measurement of Vss of ALETA-001 as appropriate.

Measurement of CL of ALETA-001 as appropriate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Study of SGN-CD19A for Leukemia and Lymphoma	NCT01786096	Burkitt Lymphom... Precursor B-cel...	SGN-CD19A	1 Year -	Seagen Inc.
A Safety Study of SGN-CD19A for B-Cell Lymphoma	NCT01786135	Burkitt Lymphom... Lymphoma, Folli... Lymphoma, Large... Lymphoma, Mantl... Precursor B-cel...	SGN-CD19A	12 Years -	Seagen Inc.
Fludarabine, Rituximab, and Alemtuzumab for B-Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	NCT00143065	Lymphoma, Small... Lymphocytic Leu...	Fludarabine Rituximab Alemtuzumab	18 Years -	Ohio State University Comprehensive Cancer Center
A Safety Study of SGN-CD19A for B-Cell Lymphoma	NCT01786135	Burkitt Lymphom... Lymphoma, Folli... Lymphoma, Large... Lymphoma, Mantl... Precursor B-cel...	SGN-CD19A	12 Years -	Seagen Inc.
A Safety Study of SGN-CD19A for Leukemia and Lymphoma	NCT01786096	Burkitt Lymphom... Precursor B-cel...	SGN-CD19A	1 Year -	Seagen Inc.
Fludarabine, Rituximab, and Alemtuzumab for B-Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	NCT00143065	Lymphoma, Small... Lymphocytic Leu...	Fludarabine Rituximab Alemtuzumab	18 Years -	Ohio State University Comprehensive Cancer Center
A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies	NCT06045910	Lymphoma, Non-H... Lymphoma, Large... Lymphoma, Mantl... Lymphoma, Folli... Lymphoma, B-Cel...	ALETA-001	16 Years -	Cancer Research UK

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