Hodgkin Lymphoma Clinical Trials

⁃ 1\. Signed informed consent form 2. Male or females age ≥ 18 years 3. Disease-Specific Criteria

⁃ a. B-cell Non-Hodgkin Lymphoma (B-cell NHL)- including the following sub-types:

⁃ i. Patients with any of the following large B-cell lymphoma diagnoses who meet the prior treatment criteria outlined below: Diffuse Large B-cell Lymphoma not otherwise specified (DLBCL NOS); Primary Cutaneous DLBCL; Primary Mediastinal (thymic) Large B-cell Lymphoma; ALK+ Anaplastic Large B-cell Lymphoma; High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangements (i.e., Double or Triple Hit); High-grade B-cell Lymphoma, NOS; T-cell Rich B-cell Lymphoma; Transformed Follicular Lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma.

⁃ 1\. Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND 2. Relapsed/refractory disease after at least 2 prior lines of appropriate therapy.

⁃ ii. Follicular Lymphoma

• Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND

• Relapsed/refractory disease after at least 2 prior lines of systemic therapy (not including a single agent monoclonal antibody therapy).

⁃ iii. Mantle Cell Lymphoma

• Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND

• Relapsed/refractory disease after at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (TKI) inhibitor. Single-agent monoclonal antibody therapy does not count towards prior lines of therapy.

• iv. Marginal Zone Lymphoma- relapsed/refractory disease after at least 2 prior lines of appropriate therapy, including a Bruton tyrosine kinase (TKI) inhibitor. Note: Single-agent monoclonal antibody therapy does not count towards prior lines of therapy.

• b. T-cell Non-Hodgkin Lymphoma (T-cell NHL)

• i. Histologically or cytologically confirmed relapsed or refractory (r/r) mature aggressive T- and NK-cell neoplasms as defined in the 5th edition of the WHO Classification of Hematolymphoid tumors, which includes any of the following diagnoses:

• • Peripheral T-cell Lymphoma, NOS (PTCL-NOS);

• • Nodal T-cell Lymphomas with T Follicular Helper \[TFH\] Phenotype, including Follicular T cell Lymphoma, Angioimmunoblastic Lymphoma, or Anaplastic Large Cell Lymphoma (ALCL);

• • ALK+ or ALK-, Enteropathy-Associated T-cell Lymphoma (EATL);

• • Monomorphic Epitheliotropic Intestinal T-cell Lymphoma (MEITL);

• • Extranodal NK/T-cell Lymphoma;

• • Primary Cutaneous T-cell Lymphoma (CTCL);

• • Transformed Mycosis Fungoides (tMF) without blood involvement;

• • Primary Cutaneous Aggressive Epidermotropic CD8+ Cytotoxic T-Cell Lymphoma;

• • Subcutaneous Panniculitis-like T-cell Lymphoma.

• ii. Must have received at least one prior line of systemic therapy for their lymphoma. Additional prior treatment provisions required for the following indications:

⁃ 1\. Participants with Anaplastic Large Cell Lymphoma (ALCL) must have received prior Brentuximab vedotin, unless contraindicated.

⁃ 2\. Participants with Subcutaneous Panniculitis-like T-cell Lymphoma or Transformed Mycosis Fungoides (tMF) must have received at least 2 prior lines of systemic therapy.

⁃ c. Hodgkin Lymphoma (HL)

⁃ i. Patients with histologically proven classical Hodgkin Lymphoma that is CD45 positive by IHC or flow cytometry by a CLIA certified laboratory; AND

⁃ ii. Relapsed/refractory disease after at least 2 prior lines of therapy which must include the following:

• Brentuximab vedotin and immune checkpoint inhibitors (unless contraindicated); AND

• Autologous stem cell transplant (unless patient has chemorefractory disease to salvage treatment) d. Large Cell Transformation of CLL (Richter's Transformation) i. Patients must be primary refractory or received at least 1 prior line of treatment for Richter's Transformation.

⁃ 4\. Patients are appropriate candidates for autologous HSCT as per physician-investigator clinical discretion

⁃ 5\. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:

⁃ a. Have no active GVHD and require no immunosuppression

⁃ b. Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility

⁃ 6\. Adequate organ function defined as:

• Serum creatinine ≤ 1.5x ULN or estimated creatinine clearance ≥ 35 mL/min and not on dialysis

• ALT/AST ≤ 3 x ULN

• Direct bilirubin ≤ 2.0 mg/dl; for patients with Gilbert's syndrome direct bilirubin must be ≤ 3.0 mg/dl

• Left Ventricular Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA

• DLCO \> 45% predicted value; adjusted for level of hemoglobin

• Must have minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air 7. ECOG Performance Status 0-1