Safety and Efficacy of Lacutamab in Patients With Relapse Peripheral T-cell Lymphoma That Express KIR3DL2

ID#: NCT05321147

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: March 17, 2022

End Date: April 28, 2023

Contact Information:
clinical trials
Summary: This is a multi-center phase Ib sutdy, which evaluates the safety and efficacy of lacutamab monotherpy in patients with relapse peripheral T-cell lymphoma that express KIR3DL2.

Inclusion Criteria:

1. Any subtype of relapsed PTCL

2. Patients should have received at least one prior systemic therapy including a CHOP-like chemotherapy;

3. Presence of at least 1 target lesion on PET/CT scan at screening;

4. Male or Female, at least 18 years of age;

5. ECOG performance status ≤ 2;

6. The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy;

7. Patients should have recovered from all adverse events from prior therapies related to prior therapy to ≤ grade 1 except for alopecia. Some AE's from prior therapies maybe permitted after discussion and consultation with the medical monitor;

8. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12 months and capable to become pregnant. They must have a negative serum beta-HCG pregnancy test result within seven days before start of treatment;

9. Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug

10. Signed informed consent form prior to any protocol-specific procedure.

Exclusion Criteria:

1. Treatment with > 2 lines of systemic therapies prior to enrollment. Consolidation therapy including stem cell transplant is not considered a line of therapy;

2. Primary refractory patients who progress while receiving first line systemic therapy;

3. Patients having a life expectancy of less than 3 months;

4. Receipt of live vaccines within 4 weeks prior to treatment;

5. Central nervous system (CNS) lymphoma involvement;

6. Prior treatment with lacutamab;

7. Concurrent enrollment in another clinical trial, unless it is an observational (non

- interventional) clinical study or the follow-up period of an interventional study.

8. Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents or immunotherapy;

9. Autologous stem cell transplantation less than 3 months prior to enrollment;

10. Prior allogenic transplantation;

11. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;

12. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;

13. Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ;

14. Pregnant or breastfeeding women;

15. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;

16. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.