Inclusion Criteria:
1. Voluntarily signed informed consent form.
2. Relapsed/refractory patients with histologically or cytologically confirmed diagnosis
of advanced-stage or recurrent cancer, including:
Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group
B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic
leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma,
cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved
package labeling of the ICI)
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
4. Life expectancy > 3 months as assessed by the Investigator
5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors
(RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
Exclusion Criteria:
1. Any malignancy of Vγ9Vδ2 T cell origin
2. Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination
half-life (whichever is shorter) before study treatment (does not apply to patients
receiving ICI for the combination arm)
3. Treatment with investigational drug(s) within 28 days before study treatment
4. Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or
equivalent, for the last 28 days and need for ongoing treatment.
5. Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic,
visceral spread, with a risk of life-threatening complications in the short term
(e.g., during Screening Period/ treatment washout) that includes patients with massive
uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and
over 50% liver involvement
6. Ongoing immune-related adverse events (irAEs) and/or AEs ≥grade 2 not resolved from
previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and
stable endocrinopathies with replacement hormone therapy.
7. Within 4 weeks of major surgery
8. Documented history of active autoimmune disorders requiring systemic immunosuppressive
therapy within the last 12 months
9. Primary or secondary immune deficiency
10. Active and uncontrolled infections requiring intravenous antibiotic or antiviral
treatment