Actively Recruiting
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
Led by Aurigene Discovery Technologies Limited · Updated on 2026-04-17
40
Participants Needed
27
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Adequate bone marrow and organ function including ANC 1000/bcL without growth factor support
- Platelet count 75,000/bcL without transfusion support
- Hemoglobin 9 g/dL (transfusion allowed to achieve this level)
- Total bilirubin 1.5 times upper limit of normal (ULN), or 2.5 times ULN if known Gilbert's syndrome
- AST and ALT levels 3 times ULN or 5 times ULN if known liver metastases
- Creatinine clearance 30 mL/min (measured or estimated)
- Ability to swallow and retain oral medications
- Histopathological diagnosis of Non-Hodgkin lymphoma or Hodgkin lymphoma, Stage III or IV by Lugano classification
- For lymphoma types where high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) is standard, disease relapsed after HD-ASCT, or patient is ineligible or refuses HD-ASCT
- For lymphoma types where CAR-T therapy is standard, disease relapsed after CAR-T, or patient refuses or lacks access to CAR-T
- Measurable disease per Lugano Criteria
- No available curative treatments; patient must have exhausted all effective locally available therapies
- Must have received at least two prior lines of systemic therapy
You will not qualify if you...
- Received systemic anti-cancer therapy (chemotherapy, biological therapy, immunomodulatory drugs) within 28 days or 5 half-lives prior to study start
- Acute or chronic toxicity from prior cancer treatment above Grade 1 except alopecia or nail changes
- Definitive radiotherapy within 21 days prior to study start (limited palliative radiation allowed)
- Use of investigational agents within 28 days or 5 half-lives prior to study start
- Diagnosis of cutaneous lymphomas such as mycosis fungoides or S�e9zary syndrome
- Primary central nervous system (CNS) lymphoma or untreated/recently treated symptomatic CNS lymphoma within 6 months
- Lymphoma requiring immediate cytoreductive therapy
- Use of drugs that are sensitive substrates of CYP2C8, P-glycoprotein or breast cancer resistance protein that cannot be stopped one week prior
- Major surgery within 28 days prior to study start
- Active infections requiring systemic treatment
- Known HIV infection or AIDS-related illness
- Active or chronic hepatitis B or C infection
- Expected to require other antineoplastic or targeted therapies during study
- Uncontrolled heart failure, recent major cardiovascular events or arrhythmias requiring treatment
- QTc interval >460 ms on ECG at screening or pre-dose
- Uncontrolled serious illnesses or medical conditions that may affect study participation
- Current or suspected COVID-19 infection at screening or study start
- History of other primary cancers within 5 years except treated skin or cervical cancers
- Positive pregnancy test or lactating women without surgical sterilization or reliable contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Omega Cancer Hospitals
Visakhapatnam, Andhra Pradesh, India, 530040
Actively Recruiting
2
Post Graduate Institute of Medical Education & Research,
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
3
Cellcure Care Cancer Pvt Ltd
Ahmedabad, Gujarat, India, 380009
Actively Recruiting
4
HCC Happiness Care and Cure Multispeciality Hospital
Ahmedabad, Gujarat, India, 380015
Actively Recruiting
5
Shankus Hospital Pvt. Ltd.
Ahmedabad, Gujarat, India, 384110
Actively Recruiting
6
Unique Hospital
Surat, Gujarat, India, 395002
Actively Recruiting
7
Kiran Multi Speciality Hospital
Surat, Gujarat, India, 395004
Actively Recruiting
8
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, Haryana, India, 124001
Actively Recruiting
9
Super Specialty Hospital (G.M.C) Srinagar
Srinagar, Jammu and Kashmir, India, 190010
Actively Recruiting
10
KLES Dr Prabhakar Kore Hospital and MRC
Belagavi, Karnataka, India, 590010
Actively Recruiting
11
Amrita Institute of Medical Sciences (AIMS)
Kochi, Kerala, India, 682041
Actively Recruiting
12
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation
Amravati, Maharashtra, India, 444606
Actively Recruiting
13
Dr. Bafna's Star Superspeciality Clinic & Hospital
Kolhāpur, Maharashtra, India, 416005
Actively Recruiting
14
Kolhapur Cancer Centre
Kolhāpur, Maharashtra, India, 416234
Actively Recruiting
15
Mumbai Onco Care Centre
Mumbai, Maharashtra, India, 400056
Actively Recruiting
16
All India Institute of Medical Sciences
Nagpur, Maharashtra, India, 441108
Actively Recruiting
17
HCG Manavata Cancer Centre
Nashik, Maharashtra, India, 422002
Actively Recruiting
18
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, India, 411004
Actively Recruiting
19
Sahyadri Super Specialty Hospital
Pune, Maharashtra, India, 411006
Actively Recruiting
20
Sushrut Hospital
Pune, Maharashtra, India, 411038
Actively Recruiting
21
Armed Forces Medical College
Pune, Maharashtra, India, 41140
Actively Recruiting
22
Sunact Cancer Institute Pvt. Ltd
Thane, Maharashtra, India, 400615
Actively Recruiting
23
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, National Capital Territory of Delhi, India, 110085
Actively Recruiting
24
All India Institute of Medical Sciences
Delhi, New Delhi, India, 10029
Actively Recruiting
25
Sparsh Hospital and Critical Care (P) Ltd.
Bhubaneswar, Odisha, India, 751007
Actively Recruiting
26
MNJ Institute of Oncology & Regional Cancer Centre
Hyderabad, Telangana, India, 500004
Actively Recruiting
27
Tata Medical Center
Kolkata, West Bengal, India, 700160
Actively Recruiting
Research Team
S
Suchit Kumbhare
CONTACT
S
Suresh Oduru
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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