Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

Phase 1

Active, not recruiting

• Conditions: Anaplastic Large Cell Lymphoma; Primary Mediastinal Large B-Cell Lymphoma (PMBCL); Peripheral T Cell Lymphoma; Extranodal NK/T-cell Lymphoma; Diffuse Large B Cell Lymphoma
• Interventions: Drug: CD30.CAR-T

• Registration Number: NCT04526834
• Lead Sponsor: Tessa Therapeutics

Brief Summary

This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma

Detailed Description

Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells.

CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine.

Subjects will be closely monitored for DLT and safety.

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-26
• Study Start: 2021-09-08
• Primary Completion: 2022-11-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20
• Study Completion: 2036-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:

1. Signed Informed Consent Form
2. Male or female patients who are 18-75 years of age
3. Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
4. Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor
5. At least 1 measurable lesion according to the Lugano Classification
6. ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy >12 weeks

Exclusion Criteria

1. CNS involvement by malignancy

2. Inadequate laboratory abnormalities at screening:

   Hgb ≤ 8.0 g/dL Total bilirubin > 1.5 x ULN (>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR >1.5 x ULN aPTT> 1.5 x ULN

3. Active uncontrolled bleeding or a known bleeding diathesis

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

5. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (>10 mg/day prednisone or equivalent for >48 hours)

6. Received prior therapy of:

   Anti-CD30 Ab based therapy within the previous 8 weeks Previous CD30.CAR-T investigational product Bi-specific CD30 Ab within the previous 8 weeks Allogenic HSCT in the last 180 days Autologous HSCT within 90 days

7. Active GVHD requiring immune suppression regardless of grade

8. HIV positive

9. Active HBV and/or HCV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD30 positive NHL subtypes	CD30.CAR-T	(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL) Dose Level 1 Dose Level 2 Dose Level 3

Primary Outcome Measures

Name	Time	Method
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose	Day 0 to 28 for DLT	Incidence of DLTs and occurrence of study related adverse events

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year	ORR
Progression Free Survival (PFS)	Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year	PFS
To evaluate pharmacokinetics of autologous CD30.CAR-T	Start of infusion of CD30.CAR-T (Day 0) until year 5	AUC (copies/ug DNA over time)
Duration of Response (DOR)	Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year	DOR

Trial Locations

Locations (4)

The University of Texas MD Anderson Cancer Centre; 🇺🇸 Houston, Texas, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

City of Hope; 🇺🇸 Duarte, California, United States