A Phase 2 Multi-Center Study Evaluating the Safety and Efficacy of CD30-Directed Genetically Modified Autologous T Cells (CD30.CAR-T) in Adult and Pediatric Patients with Relapsed or Refractory CD30 Positive Classical Hodgkin Lymphoma (CHARIOT TESSCAR001)
Trial Description
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.
Eligibility Requirements
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