Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)

• Status: Recruiting
• Trial end date: 2036-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tessa Therapeutics
• Treatments: Bendamustine Hydrochloride; Fludarabine

Criteria

Inclusion Criteria:

Eligibility is determined prior to blood collection . Patients must satisfy the following criteria to be enrolled in the study:

1. Signed Informed Consent Form

2. Male or female patients who are 12 - 75 years of age

3. Histologically confirmed classical Hodgkin Lymphoma

4. Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including:

• chemotherapy

• BV and/or

• PD-1 inhibitor Patients may have previously received an autologous and/or allogeneic stem cell transplant

5. CD30-positive tumor

6. At least 1 measurable lesion according to The Lugano Classification

7. Laboratory parameters: Hematological, renal and hepatic functions, and coagulation parameters

• Hgb ≥ 8.0 g/dL

• Total bilirubin ≤ 1.5 × ULN

• AST and ALT ≤ 5 × the ULN

• CrCl > 45 mL/min

• ANC >1,000/µL

• Platelets >75,000/µL

• PT or INR ≤ 1.5 × ULN; PTT or aPTT ≤ 1.5 × ULN

8. ECOG PS of 0 to 1 or equivalent [either Karnofsky PS (for patients ≥ 16 year of age) or Lansky PS (for patients < 16 years of age)]

9. Anticipated life expectancy > 12 weeks

Exclusion Criteria:

1. Evidence of lymphomatous involvement of central nervous system (CNS)

2. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement

3. Active uncontrolled bleeding or a known bleeding diathesis

4. Inadequate pulmonary function defined as pulse oximetry < 90% on room air

5. ECHO or MUGA with LVEF < 45%

6. On-going treatment with immunosuppressive drugs or chronic systemic corticosteroids

7. Having received:

• Anti-CD30 antibody-based therapy within 4 weeks prior to CD30.CAR-T infusion

• Prior investigational CD30.CAR-T

• CD30 bispecific agent within 8 weeks prior to CD30.CAR-T infusion

• Autologous HSCT within 90 days or allogeneic HSCT within 180 days prior to CD30.CAR-T infusion

8. Currently receiving any investigational agents within 4 weeks prior to study enrollment; or received any tumor vaccines within 6 weeks prior to CD30.CAR-T infusion

9. Active acute or chronic graft versus host disease (GVHD) requiring immune suppression regardless of grade

10. Evidence of human immunodeficiency virus (HIV) infection

11. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

12. Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments

13. History of hypersensitivity reactions to murine protein-containing products or other product excipients

14. Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification

15. Active second malignancy or history of another malignancy within the last 3 years

16. Women who are pregnant or intending to become pregnant; women who are breastfeeding; persons with procreative potential not using and not willing to use 2 highly effective methods of contraception

17. Any other serious, life-threatening, or unstable preexisting medical conditions